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CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff |
 
|
Document issued on: February 9, 2001
 |
U.S. Department of Health and Human
Services Division of Device User Programs and Systems Analysis |
Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.
For questions regarding the use or interpretation of this guidance contact Ann Hawthorne at (301) 594-1190 ext. 156, (301) 594-1243 ext. 145, or email cxh@cdrh.fda.gov.
Additional copies are available from the Internet at: http://www.fda.gov/cdrh/ohip/guidance/1323.pdf, or CDRH Facts-On-Demand. In order to receive this document via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number 1323 followed by the pound sign (#). Follow the remaining voice prompts to complete your request.
TABLE OF CONTENTS
Level 1 and Level 2 Guidance Documents
Using the CDRH GGP Coversheets
Federal Register (FR) Notice of Availability (NOA)
Following the CDRH GGP Conformance Checklist
CDRH Managers and Guidance Sign-off
CDRH Office and Division GGP Representatives
Public Availability of Guidance
Attachment I. Advice from the CDRH Focal Points on drafting guidance documents for the Internet
Attachment II. CDRH GGP Coversheet Templates from K:/GGP/TEMPLATES
Attachment III. Notice of Availability (NOA) Templates
Attachment IV. GGP Conformance Checklist
Attachment V. GGP Regulations Final Rule, September 19, 2000 (65 FR 56468)
| This document is intended to provide guidance. It represents the Agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. |
Who should use this manual?
All FDA employees who are involved in the
development, issuance, or application of guidance should use this manual.
How should I use this manual?
You should use this manual to help you develop,
publish, and apply CDRH guidance documents. Using this manual will help ensure that your
guidance document conforms to the FDA GGP regulations. This manual will help you develop
and publish meaningful guidance in the most efficient way possible.
What are the FDA GGP regulations?
The FDA GGP regulations are the practices
established by the FDA to assure the appropriate level of public participation in the
development of FDA guidance documents. The GGP regulations went into effect on October 19,
2000.
Where are the GGP regulations?
The GGP regulations will be in 21 CFR §10.115,
when the 2001 issue of the Code of Federal Regulations (CFR) is published. Until then, the
GGP regulations are publicly available in the Federal Register (FR) published on September
19, 2000 (65 FR 56468), a copy of which is included in this manual as Attachment V.
Who must follow the GGP regulations?
All FDA employees must follow the GGP
regulations when developing, issuing, or applying guidance documents.
Is GGP training required for all FDA employees who
develop, issue, or apply guidance documents?
Yes. 21 CFR §10.115(l)(1) requires that all FDA
employees involved in the development, issuance, or application of guidance documents
receive training on the FDA GGP regulations. CDRH will offer Center-wide training, make
the CDRH manual available on the Center Net, and offer periodic, office-specific GGP
training.
Which documents are guidance documents?
Guidance documents are defined by 21 CFR
§10.115(b) as documents prepared for FDA staff, applicants/sponsors, and the public that
describe FDA’s interpretation of or policy on a regulatory issue. Guidance documents
include, but are not limited to, documents that relate to:
Are internal memos and operating procedure documents
guidance?
Documents directed to FDA staff that also
provide guidance to applicants/sponsors or the public are guidance documents. Internal
documents that describe FDA’s day-to-day business are not guidance documents.
Examples of internal documents that are not guidance documents include staff guides on
personnel or leave policies, and directives on routing documents for assignment or review.
Which documents are not guidance?
21 CFR §10.115(b)(3) provides these additional
examples of FDA documents that are not guidance:
Are "Mammography Matters" and "User Facility Reporting
Bulletins" guidance?
No. They are not guidance documents. They are
general information documents provided to consumers and health professionals. According to
21 CFR §10.115(b)(3), they are not guidance.
Are "Dear Doctor" letters and safety alerts
guidance?
No. They are not guidance documents. They are
general information documents provided to consumers and health professionals.
Are Memoranda of Understanding (MOUs) guidance?
No. They are not guidance documents because they
do not articulate FDA policy.
What are guidance documents for?
Guidance documents represent FDA’s current
thinking on a given topic.
What is the legal effect of guidance?
Guidance documents do not establish legally
enforceable rights or responsibilities. They do not legally bind the public or FDA. 21 CFR
§10.115(d)(1).
May FDA use means other than a guidance document to communicate new policy or
new regulatory approaches?
No. FDA may not use documents and other means of
communication that are excluded from the definition of guidance documents to informally
communicate new or different regulatory expectations to a broad public audience for the
first time. FDA must follow the GGP regulations whenever we first communicate regulatory
expectations that are not readily apparent from the statute or regulations to a broad
public audience. 21 CFR §10.115(e).
Is there more than one type of guidance?
Yes. The GGP regulations establish two types of
guidance, Level 1 and Level 2. They are subject to different levels of public
participation in their development before FDA implements them.
What is Level 1 guidance?
According to 21 CFR §10.115(c)(1), Level 1
guidance documents include documents that:
(i) Set forth initial interpretations of statutory or
regulatory requirements,
(ii) Set forth changes in interpretation or policy that are of more than
a minor nature,
(iii) Include complex scientific issues, or
(iv) Cover highly controversial issues.
What is Level 2 guidance?
According to 21 CFR §10.115(c)(2), Level 2
guidance documents are documents that set forth existing practices or minor changes in
interpretation or policy. Level 2 guidance documents include all guidance documents that
are not classified as Level 1.
Who determines whether a guidance document is Level 1 or Level 2?
Managers in the Branch, Division, or Office developing the
guidance should determine whether the guidance is Level 1 or Level 2 following 21 CFR
§10.115(c).
What do draft and final mean?
Draft means that the guidance document is not for implementation,
it is being issued only for public comment. Final means that we are implementing the
guidance when we issue it. FDA continues accepting public comment on all final guidance
documents.
What is Immediately-in-Effect?
When public comment is not feasible or
appropriate, FDA may issue a Level 1 guidance as an Immediately-in-Effect instead of
draft. FDA implements this type of Level 1 guidance as soon as it is available on the
Internet and in hard copy.
What is Level 1 draft guidance?
Generally, once you determine that your guidance
document is Level 1, you will first prepare and issue a Level 1 draft. The Level 1 draft
is issued for public comment and marked, "Draft Not for Implementation."
What is required for a Level 1 draft?
FDA is required to announce the
availability of the guidance in the Federal Register (FR), provide a public comment
period, and make the guidance document available on the Internet and in hard copy.
Does a Level 1 draft always require an Notice of Availability (NOA)?
Yes, 21 CFR §10.115(g)(1)(ii)(A)
requires that we publish an NOA in the Federal Register (FR) announcing the availability
of a Level 1 draft.
How long is the comment period for a Level 1 draft?
CDRH generally provides a 90 day public comment period. You
cannot implement a Level 1 draft until you publish it as a Level 1 final.
Are we required to mark "Draft Not for Implementation" on every
page of a draft guidance?
Yes. CDRH includes "Draft Not for
Implementation" as the header on every page of a draft guidance document. It is
best to use the Header feature in Microsoft WORD when writing the guidance; a watermark is
not required and can cause significant word processing/file conversion problems.
What is Level 1 final guidance?
FDA issues the Level 1 final after we review the
public comments received on the Level 1 draft. We may revise the guidance document based
on our review of the comments. We may explain changes or respond to the comments by
discussing them in the NOA for the Level 1 final.
Do I have to respond to every comment received on a Level 1 draft?
No. Generally, we respond only to very significant comments on
the Level 1 draft when we publish the Level 1 final.
Does a Level 1 final always require an NOA?
Yes, 21 CFR §10.115(g)(1)(iv)(B) requires that
we always publish an NOA when we publish a Level 1 final.
Do we still accept public comments on Level 1 final guidance
documents?
Yes, 21 CFR §10.115(g)(5) allows the public to
comment on all final guidance documents. We will revise final guidance in response to
public comments when appropriate.
Is there a deadline for issuing a Level 1 final after issuing the
draft?
The regulations do not give a specific timeframe for issuing a
final. However, you cannot implement the guidance until it is published as final.
Can we revise a final guidance document?
Yes. We may revise any final guidance document,
whenever we deem appropriate. The nature of the revisions determines whether we issue the
revised document as Level 1 or Level 2.
Can we issue another Level 1 draft before we make the guidance final?
Yes, with another Notice of Availability in the
Federal Register and another comment period. Remember that you cannot implement the
guidance until we issue it as final.
What is a Level 1 Immediately-In-Effect?
21 CFR §10.115(g)(2) allows us to implement a Level 1 guidance
without a comment period whenever prior public participation is not feasible or
appropriate. It is issued as Level 1 Immediately-in-Effect and implemented immediately
upon publication.
What are the reasons for publishing a Level 1 as Immediately-in-Effect?
These limited exceptions to public participation
in developing guidance include situations where:
There are public health reasons for immediate implementation of the guidance document;
There is a statutory requirement, executive order, or court order that requires immediate implementation; or
The guidance document presents a less burdensome policy that is consistent with public health.
Do we publish an NOA for a Level 1 Immediately-in-Effect?
Yes. 21 CFR §10.115(g)(2)(i)(A) requires that we publish an NOA
and provide a public comment period when we issue a Level 1 Immediately-in-Effect. In the
NOA, we explain why the guidance document is Immediately-in-Effect.
Can we issue Level 2 draft guidance?
No. FDA must provide a public comment period for
a draft. There are no provisions for a public comment period for a Level 2 in the GGP
regulations. If you have reasons for issuing it as draft, your document likely meets the
definition for Level 1.
Can we withdraw a Level 2 and reissue it as a Level 1 draft?
Yes. If the determination of Level 2 proves
incorrect because the document is highly controversial when issued, we may withdraw it and
reissue it as a Level 1 draft.
What are the CDRH GGP Coversheets?
The CDRH GGP Coversheets are the Center’s
templates to ensure that the guidance has a uniform appearance and contains all the
elements required by the GGP regulations. You should always begin writing your guidance
document with the appropriate GGP Coversheet.
How many kinds of CDRH GGP Coversheets are there?
There are three kinds of CDRH GGP Coversheets:
Where do I obtain a CDRH GGP Coversheet?
The CDRH GGP Coversheets are available in
Microsoft WORD on the CDRH shared drive: K:\GGP\TEMPLATES (see also Attachment II of this manual).
How do I use a CDRH GGP Coversheet?
Each GGP coversheet contains three pages: cover,
preface, and title page.
| (1) | Open the CDRH GGP Coversheet file on the shared drive as a Read Only file. | ||||||
(2) |
Save it to your hard drive under any file name you choose, keeping the fonts, justifications, and margins exactly as shown. |
||||||
(3) |
Only fill in the information described below. (All the other information, such as date, docket number, CDRH Facts-On-Demand (FOD) number, etc., will be added for you just before the guidance is published.)
|
What is the non-binding effect statement?
The non-binding effect statement must be in all
CDRH guidance documents by regulation, per 21 CFR §10.115(i)(1)(iv). It reads:
| This document is intended to provide guidance. It represents the Agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind the Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. |
Where should the non-binding effect statement appear in the guidance document?
The GGP regulation, 21 CFR §10.115(i)(1)(iv),
requires us to place the non-binding effect statement immediately under the title on the
first page of text in bold or italic. In CDRH guidance, use 12 pt Times Roman font, bold,
italic, and box the text as shown above.
What about information I don’t know, for example, the publication date or
Docket number?
Your Office GGP Rep or OSM/DID adds the Federal
Register publication date, Docket number, Facts-On-Demand (FOD) number, etc. for you just
before the guidance is published.
How do I know the exact title and date of a previous document (when my guidance
is replacing a previous document or version)?
If your guidance supersedes or replaces a
currently available guidance in your Branch or Division, you should check the CDRH GGP
database on the Internet at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfGGP/search.CFM
for the exact title and date. Use the exact title and date as shown on the Internet when
you fill in the line on the Cover page that reads, "This document supersedes
document…"
How do I write a guidance document in CDRH?
First, work with your management to determine
whether your guidance document is a Level 1 or Level 2, and then whether it is a draft,
final, or Immediately-in-Effect.
What kind of format or outline should I use for my guidance document?
You must start with the correct GGP Coversheet.
The GGP regulations do not specify any particular format or outline for the body of the
document. Some Offices or Divisions may have guidance document templates. Employees should
apply the principles of Plain Language when writing guidance. Information about writing in
Plain Language is on the Internet at www.plainlanguage.gov.
Information about writing WORD documents for conversion to Internet documents is in Attachment I.
What are the standard elements that must be in every
guidance document?
The standard elements that must be included in every guidance
document are listed in 21 CFR §10.115(i)(1). We designed the CDRH GGP Coversheet to
ensure that you include all the standard elements required by the GGP regulations. To have
all the standard elements, you must:
Are there other elements that I should include in CDRH guidance documents?
Yes, you should include the Least Burdensome
paragraph in all medical device-oriented, final guidance documents in CDRH.
What is the Least Burdensome paragraph for?
The Least Burdensome paragraph is language that highlights the
importance of the least burdensome provisions of the Federal Food, Drug, and Cosmetic Act.
All employees need to consider the least burdensome approach when writing guidance.
What does the Least Burdensome paragraph say?
There are two Least Burdensome paragraphs, both
are shown below. There is one for guidance that addresses device approvals and clearances,
and another for all other aspects of the total product life cycle, such as compliance,
enforcement, outreach, surveillance, and reporting.
For final guidance documents that address device approvals and clearances:
The Least Burdensome Approach
The issues identified in this guidance document represent those that we believe need to be addressed before your device can be approved/cleared for marketing. In developing the guidance, we carefully considered the relevant statutory criteria for Agency decision-making. We also considered the burden that may be incurred in your attempt to comply with the guidance and address the issues we have identified. We believe that we have considered the least burdensome approach to resolving the issues presented in the guidance document. If, however, you believe that information is being requested that is not relevant to the regulatory decision for your pending application or that there is a less burdensome way to address the issues, you should follow the procedures outlined in the "A Suggested Approach to Resolving Least Burdensome Issues" document. It is available on our Center web page at: http://www.fda.gov/cdrh/modact/leastburdensome.html
For final guidance documents that address all other aspects of the total product life cycle:
The Least Burdensome Approach
We believe we should consider the least burdensome approach in all areas of medical device regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that the information requested in the guidance is not relevant to the decision-making process or that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be found on the Internet at http://www.fda.gov/cdrh/resolvingdisputes/ombudsman.html.
Where should I place the Least Burdensome paragraph in my final guidance
document?
In CDRH, we usually place the Least Burdensome
paragraph at the end of the Introduction or Background, whichever appears first in the
guidance document.
Should I include the Least Burdensome paragraph in any draft guidance
documents?
No. Do not include the Least Burdensome
paragraph in draft guidance. Draft guidance documents are made available for comment
purposes only. Therefore, we expect that any comments about whether there is a less
burdensome approach will be included in the comments received.
Are guidance documents developed with International organizations required to
contain the standard elements?
A draft guidance resulting from negotiation with
an International organization does not have to contain the standard elements required by
21 CFR §10.115(i)(1). It also may contain mandatory language, contrary to 21 CFR
§10.115(i)(2). However, if and when we issue the guidance as final, it must conform
to all GGP regulations including 21 CFR §10.115(i)(1) and §10.115(i)(2).
How do I write the title of my guidance document?
You should state the generic name or type of
device and the regulatory activity to which the guidance pertains, for example,
"Addendum to the Instructions for Completing FDA form 3500A with Coding Manual
(MEDWATCH) (MDR)" or "Guidance on 510(k) Submissions for Keratoprostheses."
Please try to keep your title as short as possible, and avoid extraneous words or phrases
such as "for the Content and Format of."
What should be in the title of a guidance document?
You should state the common name of the device
and describe the regulatory activity or submission in the title. These are some examples
of titles of CDRH guidance documents:
Alternative to Certain Prescription Device Labeling Requirements
Guidance on the Recognition and Use of Consensus Standards
Refractive Implants: Guidance for Investigational Device Exemptions (IDE) nd Premarket Approval (PMA) Applications; Draft
Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements
What about terms such as "Review Criteria" or
"Points to Consider"?
You should avoid using these terms. These terms
imply that there could be different legal effects. One goal of the GGP regulations is to
clarify the meaning and legal effect of guidance. Standardizing the titles and making
guidance recognizable as guidance helps achieve this goal.
What about Compliance Policy Guides (CPGs)?
CPGs are guidance documents. Historically, FDA
has issued regulatory guidance to its field staff through documents called Compliance
Policy Guides (CPG's), and those documents have come to be recognized by that name.
Therefore, FDA will continue to issue CPG's, but each CPG will also include the term,
"guidance" in its subtitle in order to clarify that it does fall within the
definition of a guidance document and must follow the GGP regulations.
Do I need a Table of Contents?
A Table of Contents is not required, however, it
is helpful in longer documents. It is best to insert the table of contents after the
Preface page of the coversheet. If you want to have a Table of Contents in your guidance
document, please always use the Microsoft WORD pulldown menu: Insert and the Indexes
and Tables feature in it. Tables of Contents created manually cause substantial
problems when documents are edited and when files are converted for the Internet.
What is mandatory language and when can I use it?
Guidance documents must not include mandatory
language such as "shall," "must," "require," or
"requirement," unless you are using these words to describe a statutory or
regulatory requirement. 21 CFR §10.115(i)(2). Please note that the construction,
"are to be," as in "data are to be submitted," is mandatory language
and must not be used unless you are describing a statutory or regulatory requirement.
Is "should" OK?
Yes. It is ok to use "should" in
guidance documents. Should is not mandatory language.
What is an NOA?
An NOA is a notice of availability, published in the Federal
Register (FR) announcing that a government document is available. The GGP regulations
require us to publish NOAs for all Level 1 guidance documents.
When do I need an NOA?
You must prepare an NOA for all Level 1 guidance
documents; draft, final, and Immediately-in-Effect. The draft NOA must accompany the
guidance through the GGP process in CDRH.
Is there a template (boilerplate) for the NOA?
Yes. There are three, one for each kind of Level
1, (draft, final, or Immediately-in-Effect).
Where do I get the template for the NOA?
The NOA templates are in the CDRH shared drive: K:\GGP\TEMPLATES
(see also Attachment III of this manual).
How do I use the NOA template?
Open the NOA template as read only, rename it
and save it on your hard drive. Then simply type in the sections that you are responsible
for.
Which sections of the NOA template am I responsible for?
You are responsible for filling in the exact
title of your guidance in the places shown throughout the template and these three
sections:
Summary
One or two sentences describing the purpose of the guidance
document.
SUPPLEMENTARY INFORMATION: I. Background
A short paragraph summarizing the background of
the guidance document.
SUPPLEMENTARY INFORMATION: II. Significance of Guidance
A short paragraph summarizing the significance
of the guidance (e.g., what new legal interpretations or changes in policy are stated in
the guidance document). For a Level 1 Immediately-in-Effect, state which
Immediately-in-Effect criteria it meets and explain why.
How does the GGP process work in CDRH?
Before a CDRH guidance document can be posted,
CDRH management must sign off on the guidance document and, when notices are required, on
the Federal Register Notice of Availability. Using the CDRH Guidance Document GGP
Conformance Checklist (GGP Checklist, see Attachment IV) will
ensure that you follow GGP process correctly.
What is the CDRH Guidance Document GGP Conformance
Checklist?
The CDRH Guidance Document GGP Conformance
Checklist (GGP Checklist) ensures and documents that you have followed the GGP procedures
in developing and publishing your guidance. The GGP Checklist also ensures that your
guidance conforms to the GGP regulations and has been reviewed by appropriate staff.
Where do I get a CDRH Guidance Document GGP Conformance
Checklist?
The CDRH Guidance Document GGP Conformance
Checklist is in the Microsoft WORD file in the shared drive: K:\GGP\CHECKLISTS\COMBINED
CONFORMANCE CHECKLIST.
How do I use the CDRH Guidance Document GGP Conformance Checklist?
Open the file as read only and save it on your
hard drive. Then begin filling in the information required for the Checklist’s Step
1.
What is "Authorization for Review and Comment" in Step 1 of the
Checklist?
The first manager in the chain of command
originating the guidance may use this signature line to authorize internal FDA review and
comment. Authors developing guidance should seek comments from other Offices with relevant
scientific expertise or similar device concerns. For example, you should seek comments or
consult with the Office of Science and Technology (OST) in CDRH and Centers such as the
Center for Biologic Evaluation and Research (CBER) whenever appropriate.
When do I fill in Step 2(A) of the Checklist?
You may use the block in Step 2(A) for a Level 1
final to document the names and organizations of anyone who has submitted public comments
in the GGP process. You may also use Step 2(A) to document internal comments.
When do I fill in Step 2(B) of the Checklist?
Use Step 2(B) only for Level 1
Immediately-in-Effect guidance documents. Please check off the exception to public
participation that applies to your guidance document.
Who fills in Step 3 of the Checklist?
Your Division GGP Representative should check
each item described in Step 3, Package Contents, and sign off indicating that all GGP
requirements have been met.
How do I use Step 4 of the Checklist?
Step 4 is the Center’s documentation that
the guidance meets the GGP requirements, and that you have obtained the appropriate
signatures. It is also the guidance document’s tracking sheet and your route slip.
Who completes Step 5 of the Checklist?
The Office and Division GGP Representatives
complete Step 5. Their duties are explained below in the section entitled, "Office
and Division GGP Representatives."
Who signs the GGP Checklist in CDRH?
All CDRH guidance documents should be reviewed
and signed off by the Division GGP Representative, Branch Chief, Division Director, Office
GGP Representative, and Office Director (or their designees) responsible for issuing the
guidance document. All CDRH guidance should be forwarded to the Office of the Center
Director, OCD. OCD must sign or initial the GGP Checklist for all CDRH guidance
documents before they are posted.
Are there additional signatures on Level 1 drafts and
finals?
Yes. The Office of Chief Counsel (OCC) must
clear the release of a draft or final guidance document that describes new legal
interpretations. The Office of Policy (OP) must clear the
release of a draft or final guidance document that describes significant changes in FDA
policy.
What is the first-line manager responsible for when signing the GGP Checklist?
The first-line manager (e.g., Branch Chief) should ensure that
the guidance document conforms to the GGP regulations, is scientifically sound, and is
free of errors. The Branch Chief must indicate on the GGP Checklist, under his or her
signature, whether the author of the guidance document has considered the relevant least
burdensome provisions of FDAMA.
Who should check the FDAMA Least Burdensome box?
The first-line manager signing-off on Step 4,
should confirm that the author has considered the relevant least burdensome provisions of
FDAMA by checking the yes\no box.
What is the Division Director responsible for when signing the GGP Checklist?
The Division Director should also ensure that the
guidance document conforms to the GGP regulations, is scientifically sound, and free of
errors. The Division Director should alert the Office Director about any potential
issues in the guidance that need special Office Director or OCD review.
What is the Office Director responsible for when signing
the GGP Checklist?
The Office Director should determine whether
there are any specific issues for OCD review and cite these issues immediately under his
or her signature on the GGP Checklist. The Office Director should also indicate on the GGP
Checklist whether the guidance document describes new legal interpretations (requiring OCC
review) or significant changes in FDA policy (requiring OP review).
As an Office Director in CDRH, what do I do after I sign-off in Step 4?|
You should forward all Level 1 and Level 2
guidance documents to OCD. You should also specify whether there are any issues for OCD
review. Check the OCD review box and use the blank space below it to describe the issues.
Do I do anything differently when I sign a Level 1 guidance?
Yes. When you sign off on a Level 1 guidance,
you should indicate whether Office of Chief Counsel (OCC) and
Office of Policy (OP) signatures are required after OCD sign-off. OCC clears draft or
final guidance documents that describe new legal interpretations. OP clears draft or final
guidance documents that describe significant changes in FDA policy.
What do the Office GGP Reps do?
Office GGP Representatives help ensure that all
guidance documents conform to the GGP regulations, and that CDRH guidance documents are
made available in a correct and timely fashion.
Office GGP Representatives:
Does the Office Rep request a new FOD number for every guidance document?
No. If your document is replacing a currently
available document, your document should use the FOD number in the version being replaced.
The Office Representative should write that number in Step 5 of the GGP Checklist.
Is there an email format for requesting an FOD number?
Yes. This is the format you should use to
request an FOD number from the Center’s GGP/FOD Focal Point, for a new document:
Title: Insert title GGP: State whether guidance is Level 1 or 2, and draft or final
This document supersedes Insert title being replacedOrigin: Insert Office/Division/Branch FOD: requesting FILENAME: Insert K drive folder and filename
Is there an email format for notifying the GGP Focal Points and Center Liaison
that a guidance is ready to post on the Internet and FOD?
Yes. It is the same as the format you should use
to request an FOD number:
| Title: | Insert title |
| GGP: | State whether guidance is Level 1 or 2, and draft or
final This document supersedes Insert title being replaced |
| Origin: | Insert Office/Division/Branch |
| FOD: | Insert (in bold) FOD number |
| FILENAME: | Insert K drive folder and filename |
What do the Division GGP Reps do?
The Division GGP Representative signs-off the
GGP checklist in Step 3. His or her signature documents that the guidance document
conforms to the GGP regulations.
Additionally, Division GGP Representatives:
How does the Division GGP Rep verify that guidance is on the Internet?
The Division GGP Rep should check the CDRH GGP
database on the Internet at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfGGP/search.CFM,
5 days after receiving the signed GGP Checklist from the Office GGP Rep.
How does the Division GGP Rep verify that guidance is on FOD?
The Division GGP Rep should check FOD at 301 827-0111, 5 days
after receiving the signed GGP Checklist from the Office GGP Rep.
How will the public know what guidance is available?
There are two ways, both required by the GGP
regulations, the Current GGP List and the annual publication of the GGP Comprehensive List
in the Federal Register.
What is the Current GGP list?
Under 21 CFR §10.115(n), FDA must maintain a
current list of all guidance documents on the Internet at www.fda.gov/opacom/morechoices/industry/guidedc.htm.
New documents will be added to this list within 30 days of issuance.
Who maintains the Current GGP list on the Internet?
In CDRH, the Center GGP Liaison (in OHIP), DSMA,
and OSM work together to ensure that new CDRH documents are added to the FDA list within
30 days of issuance as required by the GGP regulations.
Who’s responsible for the annual publication of the
GGP Comprehensive List in the Federal Register?
FDA Office of Policy publishes the annual GGP
Comprehensive List in the Federal Register. In CDRH, the Center GGP Liaison (in OHIP),
DSMA, and OSM work together to prepare CDRH’s section.
When does CDRH post Level 1 guidance on the Internet and Facts-On-Demand?
Generally, Level 1 guidance is posted as soon as
the publication date for the Notice of Availability is available. The official publication
date for the guidance document is the date the NOA is published.
When does CDRH post Level 2 guidance on the Internet and Facts-On-Demand?
In CDRH, Level 2 guidance is generally posted
within a few days of OCD sign-off. The official publication date for the guidance document
is the date OCD signed the GGP Checklist.
How do I find a list of all the guidance in my Office or Division?
Use the CDRH GGP Database
search engine on the Internet at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfGGP/search.CFM.
Leave the line for Document Title blank, select your Office and Division, then select
Search.
Can we revise older, pre-GGP guidance?
Yes, with management’s approval. FDA
strongly encourages employees to revise older, pre-GGP guidance.
Can we delete a guidance document?
Yes. To delete a guidance document, prepare a
request consisting of a brief statement (a bulleted list is preferred) explaining why the
guidance document should be deleted and a one or two line public notice. The public notice
will be used on the Internet and FOD to explain to the public why the guidance document
has been deleted. Your request should be concise, less than one page. Obtain the
signatures of the first-line manager or Branch Chief, Division Director, Office Director,
and Office of the Center Director (or their designees) on your request. The Office and
Division GGP Representatives do not need to sign your request, however they should each
retain a signed copy.
After the Office of the Center Director signs the request, how do we delete a
guidance document?
The Office of the Center Director will forward
the signed request to the Office GGP Representative who will ask OSM and DSMA to delete
the document from the Internet, FOD, and the Current and Comprehensive GGP lists. Office
GGP Representative also will forward a signed copy to the Division GGP Representative. OSM
and DSMA will replace the guidance document with the public notice from the request. This
notice will remain on the Internet and FOD for 6 months. We will include the deletion,
date, and reason in the next Comprehensive GGP list published in the Federal Register.
What are the mechanisms for public (including regulated industry) input in
developing FDA guidance?
The mechanisms for public input include
suggesting or submitting:
Must we post a Level 1 draft guidance before it can be discussed at an Advisory
Panel meeting or other public meeting?
Yes. After you have drafted the guidance
document, you may get input from Advisory Panels or other public meetings as a part of
following the GGP regulations to ensure appropriate public participation, including
posting the guidance that will be discussed at the meeting.
Can we seek input from FDA Advisory Panels before we draft a guidance document?
Yes, before you begin drafting a guidance
document you may seek or accept public input (e.g., by participating in or holding public
meetings). 21 CFR §10.115(g)(1)(i). You may state the topic or prepare a brief sketch or
outline of the topic. However, once you draft the guidance document, you must follow the
GGP regulations for making a guidance document available outside FDA.
Can the public write final guidance?
No. The public, including a manufacturer, may
only submit draft guidance documents for FDA consideration.
How does the public submit a draft guidance document?
The public should submit their draft through
Dockets Management Branch. The draft then becomes a Guidance Document Submission.
21 CFR §10.115(f)(3). FDA determines whether and how to revise a draft submitted by the
public. Only FDA can issue guidance, including guidance initially submitted by the public
according to the GGP regulations.
What’s the Annual Agenda?
The Annual Agenda is a list, published annually,
of possible topics for future FDA guidance document development or revision during the
next year. 21 CFR §10.115(f)(4) requires FDA to publish this list annually on the
Internet and in the Federal Register. This is a list of possible topics for the following
year. We are not restricted to only these topics. Nor are we required to act on all of
these topics.
Can the public suggest topics for guidance?
Yes. When doing so, they should address why a
guidance document on that topic is necessary.
How does the public comment on Level 1 draft guidance?
The public should send comments to FDA Dockets
Management Branch, usually, within 90 days of publication of a draft guidance document.
Instructions for submitting comments are given in the NOA and in the Preface of the
guidance document.
How does the public comment on Level 1 or Level 2 final guidance?
The public may comment on Level 1 or Level 2
final guidance at any time by sending their comments to FDA Dockets Management Branch.
How does the public comment on Level 1 Immediately-in-Effect guidance?
The public should send comments to FDA Dockets
Management Branch within 90 days of publication of a Level 1 Immediately-in-Effect
guidance document as instructed in the NOA. Level 1 Immediately-in-Effect guidance
documents are implemented as soon as they are published, but to ensure adequate public
participation, FDA provides a 90 day comment period. And, like all FDA guidance documents,
we continue to accept comments at any time.
Can the public suggest we withdraw a guidance document?
Yes. If the public finds a guidance document or
topic on the Agenda is no longer relevant or accurate, they may suggest to FDA that we
withdraw it.
How can the public be sure we are following the GGP regulations?
FDA will monitor the development and issuance of
guidance documents to ensure that we follow the GGP regulations. 21 CFR §10.115(l)(2).
What if the public believes we did not follow the GGP regulations?
The GGP regulations include provisions for the
public to raise concerns if they believe guidance was not issued according to the GGP
regulations or is being applied by CDRH as a binding requirement. 21 CFR §10.115(o). The
GGP regulations instruct the public to contact the employee’s supervisor, and
continue through the chain of command, if necessary, within CDRH. The GGP regulations
further provide that the public may involve FDA’s Chief Mediator and Ombudsman, if we are not making progress resolving concerns within
the Center.
All guidance documents are published on the Internet. Following the advice from the CDRH Focal Points will ensure that you achieve a crisp, professional look for your document, and that your WORD file is converted accurately.
Don't use tabs/spaces to create columns or tables. Use the TABLE pulldown menu in WORD. Use tables whenever you need a table or tabbed effect; otherwise the document will not look the way you intend it to.
Use the Bullet function in WORD. If you just put a symbol (like an asterisk) in front of an item when making a list, the margins and hanging indents will not convert accurately.
Stick with Times Roman fonts. You can subordinate or emphasize with typeface, i.e., bold, italic, bold italic, size, and case. But do so sparingly, and only when it imparts meaning. It can be distracting OTHERWISE.
Never use customized fonts.
Never use fonts smaller than 12-point.
Allow a margin of at least one inch on top, bottom, and both sides.
Create the Table of Contents (TOC) using the TOC option under the Insert pulldown menu in WORD. Never create a TOC by typing page numbers into a column, or with tabs and spaces. You are not required to have TOCs in guidance documents, but they are helpful in very long documents.
When putting an Internet address, check that the Internet address (URL) is valid and that you have typed or cut and pasted it accurately.
Remember that html documents do not have "pages" - so that if you print an html document it will not print out paginated.
Making accessible web pages for individuals with disabilities.
All graphics/images should be accompanied by a legend or text description.
Make meaning independent of color.
Put row and column headers in data tables.
[Times New Roman, 30 pt., Centered, Bold]
[Times New Roman, 20 pt., Bold, Italic]
This guidance document is being distributed for comment purposes
only.
Draft released for comment on [release date as stated in FR Notice]
[Times New Roman, 14pt., Bold]
[If appropriate] This document supersedes [Insert title
of previous document
and its date.] [Times New Roman, 14 pt,
Bold]
|
U.S. Department of Health and Human
Services Originating Branch |
[Header - Times New
Roman, 14 pt, Italic. Put this header on every page of the
guidance document
[Times New Roman, 24 pt., Bold, Centered]
[Times New Roman, 18 pt. Bold]
Comments and suggestions regarding this draft document should be submitted by [date 90 days from release date] to Docket No. [fill in], Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852.
or
[Use alternate wording below if date/docket are unknown]
For 90 days following the date of publication in the Federal Register of the notice
announcing the availability of this guidance, comments and suggestions regarding this
document should be submitted to the Docket No. assigned to that notice, Dockets Management
Branch, Division of Management Systems and Policy, Office of Human Resources and
Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061,
(HFA-305), Rockville, MD 20852.
[Text - Times New Roman, 12 pt.]
[Times New Roman, 18 pt. Bold]
Additional copies are available from the Internet at: http://www.fda.gov/cdrh/[specific
address], or CDRH Facts-On-Demand. In order to receive this document via your fax machine,
call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone
telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a
document. Enter the document number ((Office GGP Rep will insert FOD number)
followed by the pound sign (#). Follow the remaining voice prompts to complete your
request.
[Text - Times New Roman, 12 pt.]
[Header - Times New
Roman, 14 pt, Italic. Put this header on every page of a
draft document.]
[Times New Roman, 24 pt, Bold]
| This document is intended to provide guidance. It represents the Agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind the Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. |
[boxed text, Times New Roman, 12 pt, Bold, Italic]
[Times New Roman, 18 pt., Bold]
Guidance Document Text
[Times New Roman, 12 pt.]
[Times New Roman, 30 pt, Centered, Bold]
Document issued on: [If Level I Final, use release date of FR
Notice; if
Level II Final, use the date signed off by Office of Center Director]
[Times New Roman, 14 pt, Bold]
[If appropriate] This document supersedes [Insert title
of previous document
and its date.] [Times New Roman, 14 pt,
Bold]
|
U.S. Department of Health and Human
Services Originating Branch |
[Times New Roman, 24 pt., Bold, Centered]
Public Comment[Times New Roman, 18 pt. Bold]
Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.
For questions regarding the use or interpretation of this guidance contact [name] at
(301) [phone] or by email [log on name or initials] @cdrh.fda.gov.
[Text - Times New Roman, 12 pt.]
[Times New Roman, 18 pt. Bold]
Additional copies are available from the Internet at: http://www.fda.gov/cdrh/[specific
address], or CDRH Facts-On-Demand. In order to receive this document via your fax machine,
call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone
telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a
document. Enter the document number (Office GGP Rep will insert FOD number) followed by
the pound sign (#). Follow the remaining voice prompts to complete your request.
[Text - Times New Roman, 12 pt.]
| This document is intended to provide guidance. It represents the Agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind the Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. |
[boxed text, Times New Roman, 12 pt, Bold, Italic]
[Times New Roman, 18 pt., Bold]
Guidance Document Text
[Times New Roman, 12 pt.]
[Please insert the paragraph entitled Least Burdensome Approach at the end of the Introduction or Background, whichever appears first in the guidance document.]
[For documents about device approvals and clearances:]
The issues identified in this guidance document represent those that we believe need to be addressed before your device can be approved/cleared for marketing. In developing the guidance, we carefully considered the relevant statutory criteria for Agency decision-making. We also considered the burden that may be incurred in your attempt to comply with the guidance and address the issues we have identified. We believe that we have considered the least burdensome approach to resolving the issues presented in the guidance document. If, however, you believe that information is being requested that is not relevant to the regulatory decision for your pending application or that there is a less burdensome way to address the issues, you should follow the procedures outlined in the "A Suggested Approach to Resolving Least Burdensome Issues" document. It is available on our Center web page at: http://www.fda.gov/cdrh/modact/leastburdensome.html
[For documents about any other aspect of the total product life cycle:]
We believe we should consider the least burdensome approach in all areas of medical device regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that the information requested in the guidance is not relevant to the decision-making process or that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be found on the Internet at http://www.fda.gov/cdrh/resolvingdisputes/ombudsman.html.
Times New Roman, 30 pt., Centered, Bold]
Document Issued on: [release date as stated in FR Notice]
[Times New Roman, 14 pt. Bold]
|
U.S. Department of Health and Human
Services Originating Branch |
[Times New Roman, 24 pt., Bold]
[Times New Roman, 18 pt., Bold]
Until [date 90 days from release date], comments and suggestions regarding this document should be submitted to Docket No. [fill in number], Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Such comments will be considered when determining whether to amend the current guidance.
After [date 90 days from release date], comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance contact [name of contact person] at [phone number (optional: or by electronic mail at (email address))].
or
[Use alternate wording below if date/docket unknown - guidance issued one web, etc., before publication of NOA]
For 90 days following the date of publication in the Federal Register of the notice announcing the availability of this guidance, comments and suggestions regarding this document should be submitted to the Docket No. assigned to that notice, Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Such comments will be considered when determining whether to amend the current guidance.
After 90 days following the date of publication in the Federal Register of the notice announcing the availability of this guidance, comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch. Comments may not be acted upon by the Agency until the document is next revised or updated. For questions regarding the use or interpretation of this guidance contact [fill in name, address, phone and email]. [Times New Roman, 12 pt]
Additional copies are available from the Internet at: http://www.fda.gov/cdrh/[specific address], or CDRH Facts-On-Demand. In order to receive this document via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number (Office GGP Rep will insert FOD #) followed by the pound sign (#). Follow the remaining voice prompts to complete your request. [Times New Roman, 12 pt]
[Times New Roman, 24 pt., Bold]
| This document is intended to provide guidance. It represents the Agency’s current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind the Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. |
[Times New Roman, 12 pt, Bold, Italic]
[Times New Roman, 18 pt., Bold]
[Guidance document text]
[Times New Roman, 12 pt.]
[Please insert the paragraph entitled Least Burdensome Approach at the end of the Introduction or Background, whichever appears first in the guidance document.]
[For documents about device approvals and clearances:]
The issues identified in this guidance document represent those that we believe need to be addressed before your device can be approved/cleared for marketing. In developing the guidance, we carefully considered the relevant statutory criteria for Agency decision-making. We also considered the burden that may be incurred in your attempt to comply with the guidance and address the issues we have identified. We believe that we have considered the least burdensome approach to resolving the issues presented in the guidance document. If, however, you believe that information is being requested that is not relevant to the regulatory decision for your pending application or that there is a less burdensome way to address the issues, you should follow the procedures outlined in the "A Suggested Approach to Resolving Least Burdensome Issues" document. It is available on our Center web page at: http://www.fda.gov/cdrh/modact/leastburdensome.html
[For documents about any other aspect of the total product life cycle:]
We believe we should consider the least burdensome approach in all areas of medical device regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that the information requested in the guidance is not relevant to the decision-making process or that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be found on the Internet at http://www.fda.gov/cdrh/resolvingdisputes/ombudsman.html.
Level 1 Draft Instructions: Delete the instruction box and text in it after completing your draft. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No.
Medical Devices: Draft insert title of guidance; Availability
| AGENCY: | Food and Drug Administration, HHS. |
ACTION: |
Notice. |
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled, "Insert title of guidance." Insert a brief summary of the document and the reasons CDRH is issuing it. This section should be no more than 3 sentences. This guidance is not final nor is it in effect at this time.
DATES: Written comments concerning this guidance must be received by (RES will insert the date, 90 days after date of publication in the Federal Register).
ADDRESS: See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for single copies on a 3.5" diskette of the draft guidance document entitled, "insert title of guidance" to the Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 301-443-8818.
FOR FURTHER INFORMATION CONTACT:
Insert Name
Center for Devices and Radiological Health (HFZ- Insert mail stop)
Food and Drug Administration,
9200 Corporate Blvd.
Rockville, MD 20850
(301) Insert phone number
SUPPLEMENTARY INFORMATION:
I. Background
Insert a discussion of what the draft guidance is about. Include information to assist interested persons in understanding the document, and any history surrounding the development of the document, e.g., any Advisory Panel Meetings in which the document was discussed, or if it originated from a Guidance Document Submission If this document supercedes any other guidance document say so, and give its title and date of publication.
II. Significance of Guidance
This draft guidance document represents the agency’s current thinking on [insert the topic of the guidance document]. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the applicable statute, regulations, or both.
The agency has adopted Good Guidance Practices (GGPs), and published the final rule, which set forth the agency’s regulations for the development, issuance, and use of guidance documents (65 FR 56468, September 19, 2000). This draft guidance document is issued as a Level 1 guidance in accordance with the GGP regulations.
III. ELECTRONIC ACCESS
In order to receive "Insert title of guidance" via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt press 1 to order a document. Enter the document number (Office GGP Re: Insert FOD number, keeping the parentheses) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the draft guidance may also do so using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes the civil money penalty guidance documents package, device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturers' assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH home page may be accessed at http://www.fda.gov/cdrh.
IV. Comments
Interested persons may, on or before (RES inserts the date 90 days from date of publication in the Federal Register), submit to Dockets Management Branch (address above) written comments regarding this draft guidance. Submit two copies of any comments, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance document and received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
DATED:
Level 1 Final Instructions: Delete the instruction box and text in it after completing your draft. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. insert the docket no. used for the draft version
Medical Devices: insert title of guidance; Availability
| AGENCY: | Food and Drug Administration, HHS. |
ACTION: |
Notice. |
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled, "Insert title of guidance." Insert a brief summary of the document and the reasons CDRH is issuing it. This section should be no more than 3 sentences.
DATES: Written comments may be submitted at anytime.
ADDRESS: See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for single copies on a 3.5" diskette of the guidance document entitled, "Insert title of guidance" to the Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 301-443-8818.
FOR FURTHER INFORMATION CONTACT:
Insert Name
Center for Devices and Radiological Health (HFZ- Insert mail stop)
Food and Drug Administration,
9200 Corporate Blvd.
Rockville, MD 20850
(301) Insert phone number
SUPPLEMENTARY INFORMATION:
I. Background
Insert a concise description of what the document is about. Include information to assist interested persons in understanding the document, and any history surrounding the development of the document, e.g., Advisory Panel Meetings (include date) in which the document was discussed, or if it originated from a Guidance Document Submission. State when the Level 1 draft was made available in the Federal Register, the date the comment period closed, and address any significant comments that were received. If this document supercedes any other guidance, including its draft version, say so, and give its title and date of publication.
II. Significance of Guidance
This guidance document represents the agency’s current thinking on [insert the topic of the guidance document]. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the applicable statute, regulations, or both.
The agency has adopted Good Guidance Practices (GGPs), and published the final rule, which set forth the agency’s regulations for the development, issuance, and use of guidance documents (65 FR 56468, September 19, 2000). This guidance document is issued as a Level 1 guidance in accordance with the GGP regulations.
III. ELECTRONIC ACCESS
In order to receive "Insert title of guidance," via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt press 1 to order a document. Enter the document number (Office GGP Rep: Insert FOD number, keeping the parentheses) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do so using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes the civil money penalty guidance documents package, device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturers' assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH home page may be accessed at http://www.fda.gov/cdrh.
IV. Comments
Interested persons may, at anytime, submit to Dockets Management Branch (address above) written comments regarding this guidance. Submit two copies of any comments, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance document and received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
DATED:
Level 1 Immediately in Effect Instructions: Delete the instruction box and text in it after completing your draft. |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No.
Medical Devices: Insert title of guidance; Availability
| AGENCY: | Food and Drug Administration, HHS. |
ACTION: |
Notice. |
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled, "Insert title of guidance." Insert a brief summary of the document and the reasons CDRH is issuing it. This section should be no more than 3 sentences.
DATES: Written comments concerning this guidance must be received by (RES will insert the date, 90 days after date of publication in the Federal Register).
ADDRESS: See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for single copies on a 3.5" diskette of the draft guidance document entitled, "Insert title of guidance" to the Division of Small Manufacturers Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two self-addressed adhesive labels to assist that office in processing your request, or fax your request to 301-443-8818.
FOR FURTHER INFORMATION CONTACT:
Insert Name
Center for Devices and Radiological Health (HFZ- Insert mail stop)
Food and Drug Administration,
9200 Corporate Blvd.
Rockville, MD 20850
(301) Insert phone number
SUPPLEMENTARY INFORMATION:
I. Background
Insert a discussion of what the document is about. Include information to assist interested persons in understanding the document, and any history surrounding the development of the document, e.g., any Advisory Panel Meetings in which the document was discussed, or if it originated from a Guidance Document Submission. If this document supercedes any other guidance say so, and give its title and date of publication.
(Select one of the three choices below)
[ FDA is making this guidance document available immediately because there are public health reasons for immediate implementation. Explain why in one two sentances. ]
[ FDA is making this guidance document available immediately because there is a statutory requirement, executive order, or court order that requires immediate implementation and guidance is needed to help effect such implementation. Explain why in one two sentances. ]
[ FDA is making this guidance document available immediately because he guidance is presenting a new policy, consistent with public health, that is less burdensome than current policy. Explain why in one two sentances.]
II. Significance of Guidance
This guidance document represents the agency’s current thinking on [insert the subject or topic of the guidance document]. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the applicable statute, regulations, or both.
The agency has adopted Good Guidance Practices (GGPs), and published the final rule, which set forth the agency’s regulations for the development, issuance, and use of guidance documents (65 FR 56468, September 19, 2000). This guidance document is issued as a Level 1 guidance in accordance with the GGP regulations.
III. ELECTRONIC ACCESS
In order to receive "Insert title of guidance" via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt press 1 to order a document. Enter the document number (Office GGP Rep Insert FOD number, keeping the parentheses) followed by the pound sign (#). Follow the remaining voice prompts to complete your request.
Persons interested in obtaining a copy of the guidance may also do so using the Internet. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes the civil money penalty guidance documents package, device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturers' assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH home page may be accessed at http://www.fda.gov/cdrh.
IV. Comments
Interested persons may, on or before (RES will insert date after 90 days from the date of publication in the Federal Register), submit to the Dockets Management Branch (address above) written comments regarding this immediately in effect guidance. Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance document and received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
DATED:
http://www.fda.gov/OHRMS/DOCKETS/98fr/091900a.htm
Uploaded on March 19, 2001
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