[Federal Register: April 28, 2003 (Volume 68, Number 81)]
[Notices]               
[Page 22400-22405]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap03-69]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0117]

 
Implementation of the Inspection by Accredited Persons Program 
Under the Medical Device User Fee and Modernization Act of 2002; 
Accreditation Criteria: Guidance for Industry, FDA Staff, and Third 
Parties; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
criteria it will use to accredit persons for the purpose of conducting 
inspections of eligible device manufacturers under section 201 of the 
Medical Device User Fee and Modernization Act of 2002 (MDUFMA), which 
established an ``inspection by accredited persons'' program. The new 
law requires FDA to publish in the Federal Register the criteria it 
will use to accredit persons to conduct inspections of eligible device 
establishments. These criteria are set out in this document and will 
become effective immediately after approval by the Office of Management 
and Budget (OMB) of the collection of information proposed by FDA in 
connection with this program. At that time, FDA will begin accepting 
applications for this program. In this document, FDA is also announcing 
the availability of a guidance document that will provide information 
for those interested in participating in this newly-created program. 
The guidance is entitled ``Implementation of the Inspection by 
Accredited Persons Program under the Medical Device User Fee and 
Modernization Act of 2002; Accreditation Criteria: Guidance for 
Industry, FDA Staff and Third Parties.'' In accordance with the 
agency's good guidance practices (GGPs), the guidance remains subject 
to comment at any time. FDA is taking these actions to implement 
provisions of MDUFMA.

DATES: Submit written or electronic comments on the guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance document entitled ``Implementation of the 
Inspection by Accredited Persons Program Under the Medical Device User 
Fee and Modernization Act of 2002; Accreditation Criteria: Guidance for 
Industry, FDA Staff, and Third Parties'' to the Division of Small 
Manufacturers, International, and Consumer Assistance (HFZ-220), Center 
for Devices and Radiological Health (CDRH), 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. See the 
SUPPLEMENTARY INFORMATION section VI for information on electronic 
access to the guidance. Submit written comments concerning this 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. 
Identify comments with the docket number found in brackets within the 
heading of this document.

FOR FURTHER INFORMATION CONTACT: John F. Stigi, Director, Division of 
Small Manufacturers, International and Consumers Assistance, Center for 
Devices and Radiological Health (CDRH) (HFZ-220), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-6597 
ext. 124.

SUPPLEMENTARY INFORMATION:

I. Background

    MDUFMA (Public Law 107-250) was signed into law on October 26, 
2002. Section 201 of MDUFMA adds a new paragraph ``g'' to section 704 
of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 374), 
directing FDA to accredit third parties (accredited persons or APs) to 
perform inspections of eligible manufacturers of class II or class III 
devices. This is a voluntary program; eligible manufacturers have the 
option of being inspected by an AP or by FDA. The new law requires FDA 
within 180 days from the date MDUFMA was signed into law to ``publish 
in the Federal Register criteria to accredit or deny accreditation to 
persons who request to perform'' these inspections (section 704(g)(2) 
of the act). Under section 704(g)(2) of the act, through publication of 
this Federal Register document, the criteria set out in section II of 
this document will be binding on those persons who apply to become APs 
under this program. The criteria will be in effect immediately 
following approval by the OMB of the collection of information proposed 
by FDA in connection with this program. At that time, FDA will begin 
accepting applications for accreditation.
    FDA is also issuing a guidance document that repeats the criteria 
it will use for accrediting APs. The guidance also addresses other 
aspects of this program such as the appropriate format and content for 
accreditation applications. The guidance is discussed further in 
section III of this document. Although it was not feasible to obtain 
comments before issuing the guidance due to tight statutory deadlines, 
in accordance with this agency's GGP procedures, FDA will accept 
comments on the guidance at any time.
    The new law requires that no more than 15 firms receive 
accreditation during the 12 months following publication of this 
Federal Register document. In addition, on or before October 26, 2003, 
FDA must make available on its Web site a list of accredited firms that 
may conduct inspections and the specific information about the scope of 
their accreditation. Therefore, in order to comply with this statutory 
timeframe, FDA will not accept any applications for 2003 after August 
25, 2003. The list of APs will be updated periodically but no later 
than 30 days after a new person is accredited. This update will show 
any withdrawal of accreditation or any change in activities for which 
an AP is accredited.

II. Accreditation Criteria

    This section describes the criteria FDA will apply when making 
decisions about whether to accredit persons who request to conduct 
inspections of eligible class II and class III device manufacturers in 
lieu of FDA inspection. The guidance document entitled ``Implementation 
of the Inspection by Accredited Persons Program Under the Medical 
Device User Fee and Modernization Act of 2002; Accreditation Criteria: 
Guidance for Industry, FDA Staff, and Third Parties,'' repeats these 
criteria and provides suggestions on how applicants can address them in 
their application.

A. Minimum Requirements

    Section 704(g)(3) of the act describes the minimum requirements 
that an AP must meet in order to be accredited by FDA. These 
requirements are that an AP:
    1. May not be a Federal Government employee;
    2. Shall be an independent organization not owned or controlled by 
a manufacturer, supplier, or vendor of

[[Page 22401]]

articles regulated under the act and have no organizational, material, 
or financial affiliation (including a consultative affiliation) with 
such a manufacturer, supplier, or vendor;
    3. Shall be a legally constituted entity permitted to conduct the 
activities for which it seeks accreditation;
    4. Shall not engage in the design, manufacture, promotion, or sale 
of articles regulated under the act;
    5. Shall operate in accordance with generally accepted professional 
and ethical business practices and agree in writing that, at a minimum, 
it will:
    (a) Certify that the reported information accurately reflects data 
reviewed, inspection observations made, other matters that relate to or 
may influence compliance with the act, and recommendations made during 
an inspection or at an inspection's closing meeting;
    (b) Limit work to that for which competence and capacity are 
available;
    (c) Treat information received, records, reports, and 
recommendations as confidential commercial or financial information or 
trade secret information, except such information may be made available 
to the FDA;
    (d) Respond promptly and attempt to resolve complaints regarding 
its activities for which it is accredited;
    Protect against the use of any officer or employee of the AP to 
conduct inspections who has a financial conflict of interest regarding 
any product regulated under the act, and annually make available to the 
public disclosures of the extent to which the AP, and the officers and 
employees of the person, have maintained compliance with requirements 
relating to financial conflicts of interest.

B. Additional Criteria

    In addition to the minimum requirements specified at section 
704(g)(3) of the act for becoming an AP, this notice also establishes 
the following additional criteria:
1. Personnel Qualifications
    FDA expects AP to have sufficient personnel, with the necessary 
education, training, skills and experience to review records and 
perform inspections. FDA will consider several factors when accrediting 
applicants. These include:
    (a) Whether personnel have demonstrated knowledge of:
    [sbull] The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et 
seq.);
    [sbull] The Public Health Service Act (42 U.S.C. 201 et seq.);
    [sbull] Regulations implementing these statutes, particularly 21 
CFR part 11 and parts 800-1271, with special emphasis on Parts 11, 801, 
803, 806, 807, 809, 814, 820 and 821;
    [sbull] FDA Compliance Program 7382.845, Inspection of Medical 
Device Manufacturers;
    [sbull] Guide to Inspection of Quality Systems: Quality System 
Inspection Technique (QSIT); and
    [sbull] FDA Investigations Operations Manual, Chapter 5-
Establishment Inspection.
    (b) Whether the applicant:
    [sbull] Has established, documented, and executed policies and 
procedures to ensure that inspections are performed by qualified 
personnel, and will maintain records on the relevant education, 
training, skills, and experience of all personnel who contribute to the 
performance of inspections;
    [sbull] Has available to its personnel clear, written instructions 
for duties and responsibilities with respect to inspections;
    [sbull] Has identified personnel who, as a whole, are qualified in 
all of the quality system disciplines for the inspections under the AP 
scope of work; and
    [sbull] Has identified at least one individual who is responsible 
for providing supervision over inspections and who has sufficient 
authority and competence to assess the quality and acceptability of 
inspection reports.
2. Infrastructure
    APs need the capability to interface with FDA's electronic data 
systems, including the FDA Internet Web sites, and the CDRH Facts-On-
Demand system. At a minimum, this would entail a computer system with a 
modem and an independent facsimile machine. FDA will rely extensively 
on the use of our electronic systems for timely dissemination of 
guidance documents to APs and other interested parties. APs must also 
have physical security and safeguards for protecting trade secret and 
confidential commercial or financial information, as well as personal 
identifier information in medical records, such as adverse event 
reports, that would reveal the identity of individuals if disclosed.
3. Prevention of Conflicts of Interest (COI)
    An AP must be impartial and free from any commercial, financial, 
and other pressures that might present a COI or an appearance of a COI. 
To that end, when deciding whether to accredit a person, we will 
consider whether they have established, documented, and executed 
policies and procedures to prevent any individual or organizational 
COI, including conflicts that their contractors or individual contract 
employees may have.
    Although it is not feasible to identify all of the circumstances 
that would raise concerns about COI in this document, the most common 
conditions that indicate an actual or a potential COI are:
    a. The AP is owned, operated, or controlled by a manufacturer, 
supplier or vendor of any article regulated under the act. Please see 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/yellow/yellotoc.htm for examples of 
firms that are regulated by FDA and, therefore, would create a 
conflict. This includes manufacturers of radiation-emitting electronic 
products such as televisions, microwave ovens, compact disk players, 
laser printers, industrial lasers, as well as foods, drugs, biologics, 
cosmetics, veterinary products, and medical devices.
    b. The AP has any ownership or financial interest in any product, 
manufacturer, supplier or vendor regulated under the act (see section 
II.B.3.a of this document);
    c. Any personnel of the AP involved in inspections or their spouse 
or minor children have an ownership or other financial interest 
regarding any product regulated under the act (see link at section 
II.B.3.a of this document);
    d. The AP or any of its personnel involved in inspections 
participates in the design, manufacture, promotion or sale of any 
product regulated under the act;
    e. The AP or any of its personnel involved in inspections provides 
consultative services to any manufacturer, supplier or vendor of 
products regulated under the act (see link at section II.B.3.a of this 
document);
    f. Any personnel of the AP involved in the inspection process 
participates in an inspection of a firm in which they had performed 
contract work (e.g. conformity assessment body audit, laboratory 
testing, or AP inspection) within the last 12 months;
    g. Any personnel of the AP involved in the inspection process 
participates in an inspection of a firm they were employed by within 
the last 12 months;
    h. The fees charged or accepted are contingent or based upon the 
recommendation in the report made by the AP.
    When the AP uses the services of a contractor in connection with an 
inspection, it is responsible for the work of the contractor and its 
personnel. It will be the AP's responsibility to assure that the 
contractor meets the same criteria for freedom from COI as the AP and 
its personnel.
    In addition to conducting inspections as an AP, an AP may also 
conduct other activities, such as objective laboratory testing of 
products regulated under the act or assessment of conformance to

[[Page 22402]]

standards, if those other activities do not affect the impartiality of 
inspections. Examples of conflicted laboratory testing, i.e., 
activities an AP may not perform, are routine quality production tests, 
validation/verification studies, and quality assurance-related testing.
    Information on the COI standards FDA applies to its own personnel 
is included in appendix 1 of the guidance entitled ``Standards for 
Ethical Conduct for Employees of the Executive Branch.'' An AP may 
adopt these standards, utilize the model COI policy FDA has provided as 
another appendix to the guidance, or demonstrate how alternative 
equivalent procedures will safeguard against COI.
4. Training
    An AP will not be eligible to conduct independent inspections until 
they have successfully completed the classroom training required by FDA 
and conducted a satisfactory performance inspection under FDA 
observation. Firms identified on the FDA's list of APs to perform 
inspections will designate employees to participate in the classroom 
training and joint qualifying inspections. FDA will train no more than 
three employees per AP during the training sessions to be held by FDA 
in January 2004. FDA strongly encourages each AP to send at least two 
employees to the training, in recognition of employee attrition. APs 
with multiple sites engaged in FDA inspectional activities should 
request permission from the agency to send one representative from each 
site, not to exceed a total of five representatives from each AP.
    Training for APs will be ``modeled'' after training of European 
Union Conformity Assessment Bodies (EU CABs) under the Mutual 
Recognition Agreement (MRA) Implementation Plan. (See http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/mra/guidance/mraprocedure.html.
) EU CABs that have 
been accredited as APs and whose personnel have successfully completed 
the required training and/or joint inspections under the MRA program 
should state this in their application. If confirmed by FDA, the AP 
will not be required to have a representative repeat the classroom 
training or joint qualifying inspections. However, FDA does recommend 
that the AP send a representative to the FDA Investigator Training 
module as an update. Personnel trained by FDA under the MRA program who 
do not attend the current training will need to review a videotaped FDA 
presentation on evidence development.
    The FDA training will consist of a two tiered program.
    Tier one will include formal classroom training for AP inspectional 
staffers (trainees). At a minimum this will include:
    a. The Association for the Advancement of Medical Instrumentation 
(AAMI) GMP/ Quality System: Requirements and Industry Practice (or 
equivalent). AAMI will be conducting this training throughout the 
United States and in Frankfurt, Germany in 2003; see AAMI web site at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.aami.org/meetings/courses/gmp.html\1\ for specific dates and 
locations. Please note that you must register separately for the 
training session and the examination. The AAMI training schedule for 
2004 will not be posted until late 2003.
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    \1\ FDA has verified the Web site address, but is not 
responsible for subsequent changes to the Web site after this 
document publishes in the Federal Register.
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    b. FDA's Quality System Inspection Technique (QSIT) training 
module.
    c. FDA Investigator Training, which will include training on:
    [sbull] Food and drug law,
    [sbull] Advanced QSIT,
    [sbull] FDA inspectional procedures,
    [sbull] FDA policies and device regulations and
    [sbull] Evidence development.
    FDA plans to conduct its training sessions from January 12 through 
16, 2004, in the Washington, DC metropolitan area. FDA will make a 
final decision on applications in early October 2003, and plans to 
advise applicants and post the list of APs on the Internet in mid-
October. Each applicant to this program should make tentative plans to 
send appropriate representatives to the FDA Investigator Training. 
However, only those applicants that are confirmed as APs in October 
will be eligible to attend the training. Applicants should advise FDA 
in their AP application of the names of the employee(s) that have 
either successfully completed this training or those who will be 
nominated to participate in this training. AP trainees will not qualify 
to enter the second tier, unless they successfully pass a test at the 
end of each tier one training session.
    The second tier will involve the completion of three joint 
inspections, during which FDA and the AP will address the relevant 
parts of Compliance Program 7382.845--Inspection of Medical Device 
Manufacturers and the QSIT guidance--Guide to Inspection of Quality 
Systems. The three joint inspections will include:
    (a) Collaborative Inspection--The FDA investigator will be the lead 
inspector and the AP trainee will act primarily as an observer. The FDA 
investigator will prepare a list of any nonconformities and an 
inspection report. The trainee will prepare a ``practice'' list of 
nonconformities and an inspection report.
    (b) Modified Performance Inspection--Using established criteria, 
the FDA investigator will observe and evaluate the trainee performance 
of an inspection and may provide assistance. The trainee will prepare a 
list of any nonconformities to be presented to the facility and an 
inspection report. The FDA investigator will review the list of 
nonconformities and provide feedback before it is presented. In 
addition, the FDA investigator will review the inspection report and, 
if necessary, write an addendum to supplement the inspection report.
    (c) Full Performance Inspection--The AP trainee will perform an 
independent inspection and will be observed and evaluated by the FDA 
investigator using established criteria. The FDA investigator may not 
provide assistance to the trainee. The trainee will prepare a list of 
any nonconformities to be presented to the facility and an inspection 
report. The FDA investigator will review the list of nonconformities 
and provide feedback before it is presented. In addition, the FDA 
investigator will review the inspection report and, if necessary, write 
an addendum to supplement the inspection report. The FDA investigator's 
evaluation of the trainee and recommendation will be presented to the 
FDA Office of Regulatory Affairs (ORA) certifier in the FDA Division of 
Human Resource Development who will determine if the trainee is 
qualified to perform independent inspections.
    The criteria FDA will use to evaluate the joint inspections will be 
addressed at the FDA training sessions to be held in January 2004.
5. Evaluation of the AP Application
    (a) The Third Party Recognition Board (TPRB) Chairman will e-mail 
the applicant's contact person, within 24 hours of receipt of the AP 
application, acknowledging receipt.
    (b) Members of the TPRB will perform an initial review to determine 
if the request for accreditation addresses the information set forth 
below in section II.B.6 of this document, Contents of an AP 
Application, and is adequate for review by the full TPRB.
    (c) The TPRB Chairman will advise the contact individual, via e-
mail, within 60 days after the receipt of such request for 
accreditation, whether the request is adequate for review by the TPRB 
or whether additional information is needed.

[[Page 22403]]

    (d) If the application is deficient, FDA will identify its 
shortcomings and advise the applicant so it may submit additional 
information within the designated time period. FDA may deem the 
application incomplete and deny the request for accreditation if the 
applicant fails to respond to a request for additional information in a 
timely manner. All information submitted to FDA in response to any 
requests for additional information should be received no later than 
September 25, 2003.
    (e) If the application is adequate, FDA will file it for full 
review, rating and ranking by the TPRB. A rating criteria checklist 
will be used to assess the relevant qualifications and competence of 
persons applying to become APs. The agency has assigned a weight (5, 15 
or 20) to each of eight elements. The eight elements are addressed in 
section II.B.6 of this document, Contents of an AP Application. The 
weight of the element is based on how essential the information is in 
determining if the applicant is suitable to perform Quality System / 
Good Manufacturing Practices (QS/GMP) inspections on behalf of FDA. 
Each member of the TPRB will assess each of the eight elements and will 
vote a ``quality level'' score from 0 to 4 (0 = Unsatisfactory, 2 = 
Satisfactory, 4 = Exceeds) for each element. The final Quality Level 
Score will be determined by a majority vote of the TPRB. Quality Level 
Score x Weight = Element Score. The eight element scores will be 
totaled to yield an ``Application Rating'' (maximum rating attainable 
is 400). The TPRB will then rank the applications (highest application 
rating first).
    (f) If more than 15 applicants seeking accreditation satisfy the 
minimum requirements, FDA will accredit the 15 applicants that have the 
highest scores. If fewer than 15 persons are initially accredited, 
additional applications will be considered during the 12 months that 
follow the publication of this guidance. Persons seeking accreditation 
that are not among the 15 highest ranking applications can reapply 12 
months after the publication of this guidance and persons who did not 
previously apply may also apply 12 months after publication of this 
guidance.
    (g) FDA may deny the request for accreditation if we determine that 
the application does not meet the criteria established for APs or 
scores lower than the 15 highest rated applications received by August 
25, 2003.
    (h) FDA will stop accepting applications on August 25, 2003. FDA 
plans to publish on its Web site the List of Persons Accredited for 
Inspections on or before October 26, 2003.
6. Contents of an AP Application
    Applicants should include the information described as follows:
    (a) Administrative Information
    [sbull] Application in English;
    [sbull] Name and address of the organization seeking accreditation;
    [sbull] Telephone number and e-mail address of the contact person. 
The contact person should be the individual to whom questions about the 
content of the application may be addressed and to whom a letter of 
determination and general correspondence will be directed;
    [sbull] Name and title of the most responsible individual at the 
AP. Foreign applicants may wish to identify an authorized 
representative located within the United States who will serve as the 
AP's contact with FDA;
    [sbull] Name and title of the most responsible individual at the 
parent organization, if applicable;
    [sbull] Brief description of the applicant, including: type of 
organization (e.g., not-for-profit institution, commercial business, 
other type of organization); size of organization (number of 
employees); organizational charts showing the relationship of the 
organization involved in the AP inspection program and its relationship 
with parent or affiliate companies; number of years in operation; 
nature of work (e.g., conformity assessment testing or certification 
laboratory); and sufficient information regarding ownership, operation, 
and control of the organization to assess its degree of independence 
from manufacturers and distributors of products regulated under the 
act. Please include your annual report or, if it is available 
electronically on the Internet, please include the appropriate Web site 
address. If the applicant's organization has offices in numerous 
locations, please be specific and name all locations that you plan to 
participate in the AP inspection process for your firm. Applicants may 
include all locations under one application if they will operate under 
the same processes and procedures for AP inspections. Include 
curriculum vitae (CVs) for all supervisory personnel and explain where 
supervisory oversight will be located;
    [sbull] List countries that have certified, accredited or 
recognized the applicant for quality system or GMP inspections/auditing 
and the date of such certification, accreditation, or recognition;
    [sbull] Specify any accreditation for assessment of quality systems 
that you may have, such as accreditation to ISO/IEC Guide 62. If you 
are accredited to standards other then Guide 62, please provide copies 
of the standards in English.
    [sbull] Activities for which the AP seeks accreditation. This 
includes a list identifying the devices the applicant seeks to inspect. 
Applicants may simply state ``all devices'' or identify the devices 
they wish removed from their scope of work by classification panel or 
by classification name (e.g., except cardiovascular devices under 21 
CFR part 870 or except 21 CFR 870.3620, 870.3630, 870.3640, and 
870.3670).
    (b) Prevention of Conflict of Interest
    The applicant should submit a copy of the written policies, 
procedures and sample certification/compliance statements established 
to prevent conflicts of interest. MDUFMA requires that the AP and its 
employees (including contract employees) involved in the performance of 
inspections and the preparation and approval of reports be free from 
conflicts of interest and the appearance of conflicts of interest that 
might affect the inspection process. No personnel of an AP involved in 
inspections, nor their spouses or minor children, may have ownership of 
or other financial interest in any product regulated under the act. In 
accordance with section 704(g)(3)(E) of the act, APs will annually make 
available to the public the extent to which the AP complies with 
conflict of interest requirements.
    (c) Technical Competence
    FDA will consider several factors with respect to personnel 
qualifications and the preparedness of the applicant to conduct 
technically competent inspections. The applicant should document these 
factors in its application and include:
    [sbull] The written policies and procedures established to ensure 
that manufacturers are inspected by qualified personnel;
    [sbull] The written instructions for the duties and 
responsibilities of personnel, including inspectors, with respect to 
the inspection of device manufacturing facilities;
    [sbull] The written personnel qualification standards established 
to ensure that inspectors and other designated personnel are qualified 
in all of the regulatory and technical disciplines needed to 
effectively inspect for compliance with FDA's regulatory requirements 
for medical devices;
    [sbull] The documentation (e.g., CVs) to establish that the 
inspectors and other involved non-supervisory personnel meet the 
established criteria for qualified personnel. This includes 
documentation of knowledge, education, training, skills, abilities and 
experience, including specialized education and experience needed for

[[Page 22404]]

the inspection of manufacturers' facilities;
    [sbull] The documentation (e.g., CVs) to establish that the 
supervisor(s) of inspectors have sufficient authority and meet the 
established criteria for qualified supervisory personnel. This includes 
documentation of knowledge, education, training, skills, abilities and 
experience, including any specialized education and experience needed 
to supervise the inspection and review records prepared by inspectors;
    [sbull] A description of the applicant's management structure and 
that of any contractor used for inspection work. The application should 
describe the position of the individual(s) providing supervision within 
the management structure and explain how that structure provides for 
the supervision of the inspectors and other personnel involved in the 
inspection process. (If the applicant plans to utilize contractors, 
please address the additional information described at section II.B.6.f 
of the document, Contractors);
    [sbull] A description of the inspection team. This includes 
documentation for any members of the team who may already have training 
and experience relevant to the assessment of compliance with FDA's 
regulatory requirements for medical devices (e.g., compliance programs, 
the QS regulation, and general auditing principles). The description 
should include documentation of the ability of the team to recognize, 
collect and identify evidence of noncompliance and adequately 
communicate with the manufacturer regarding the inspection;
    [sbull] Documentation that personnel involved in inspections have 
broad quality systems knowledge and are qualified in accordance with 
generally accepted quality assurance standards, (e.g., ISO 10011-2 or 
21 CFR part 820) and capable of functioning in accordance with the 
relevant parts of these standards;
    [sbull] Documentation of training plan to assure technical 
competence;
    [sbull] Documentation of records that demonstrate the appropriate 
experience and training of each inspector.
    (d) Resources
    The applicant should identify what reference materials are 
available to inspectors and other personnel involved in inspections, 
(e.g., the act, regulations, manuals, standards). Also, the application 
should identify equipment and resources available that will enable the 
inspector to perform technical and administrative tasks. At a minimum, 
this should include a computer system with a modem and an independent 
facsimile machine. FDA will rely extensively on the use of our 
electronic systems for timely dissemination of guidance documents to 
APs and other interested parties.
    APs should have physical security and safeguards in place for 
protecting trade secret and confidential commercial and financial 
information, as well as personal identifier information in medical 
records, such as adverse event reports, that would reveal the identity 
of individuals if disclosed.
    (e) Confidentiality
    The applicant should include established procedures to ensure 
confidentiality of reports and all information obtained during an 
inspection. These should address aspects of authorized disclosure and 
the procedures by which the applicant maintains confidentiality between 
itself and the manufacturer. In addition, the applicant should describe 
the procedures through which the applicant's personnel and any 
contractors are made aware of confidentiality requirements.
    (f) Contractors
    FDA will consider several factors to determine whether the 
applicant ensures that contractors are properly qualified, utilized, 
and monitored. Special emphasis will be placed on personnel 
qualifications and preparedness to conduct technically competent 
inspections, and on conflict of interest controls. The applicant should 
document these factors in the application and include:
    [sbull] The written policies and procedures established to ensure 
that contractors conform to the same requirements (e.g., education, 
training, and experience) that would apply to the applicant if it were 
performing the inspection or aspects of the inspection contracted. 
These policies and procedures should ensure that the contractor 
conducts inspections in accordance with the same procedures under which 
the applicant operates. The applicant should include assurances that it 
will maintain documentary evidence that the contractor has the 
necessary technical competence and resources to carry out contracted 
activities;
    [sbull] Written policies and procedures documenting that the 
applicant will not contract the overall responsibility for reviewing 
the results of the inspections;
    [sbull] Documentation of an agreement delineating the duties, 
responsibilities, and accountability of the contractor; and
    [sbull] The written policies and procedures for establishing a 
register of qualified contractors.
    (g) AP Quality System
    FDA will consider the following factors to determine whether the 
applicant has established an adequate quality system to ensure 
compliance with FDA policies and procedures relevant to inspections:
    [sbull] The applicant should establish a documented quality system 
to ensure that there are processes and procedures in place to 
demonstrate compliance with section 704(g) of the act;
    [sbull] The policies and procedures the applicant follows are 
adequate to maintain control of all quality system documentation and to 
ensure that a current version is available at all locations; and
    [sbull] The policies and procedures for internal auditing to ensure 
the quality system is implemented effectively and that resources are 
available for conducting such audits.
    (h) Certification Agreement Statement
    The applicant should provide a copy of a documented statement, 
which will be signed by the most responsible individual, certifying 
that:
    [sbull] The AP has appropriate policies and procedures to meet 
FDA's conflict of interest provisions, has the appropriate staff and 
procedures in place to ensure technical competence for conducting 
inspections under section 704(g) of the act, and has the quality system 
in place to ensure acceptable and consistent inspections;
    [sbull] Where the AP uses the services of a contractor for Quality 
System (QS)/GMP inspections, the AP should also certify that its 
contractor(s) meets the APs established criteria for freedom from 
conflicts of interest and technical competence;
    [sbull] The AP consents to FDA inspection and copying of all 
records, correspondence, and other materials relating to any 
inspections conducted by the AP under this program, including records 
on personnel, education, training, skills, and experience and all 
documentation on prevention of conflicts of interest, including 
certification/compliance statements; and
    [sbull] The AP will protect trade secret and confidential 
commercial or financial Information, and will treat as private 
information about specific patient identifiers in records such as 
adverse event reports, except that such information may be made 
available to FDA.

III. The Guidance

    We are also issuing a guidance entitled ``Implementation of the 
Inspection by Accredited Persons Program Under the Medical Device User 
Fee and Modernization Act of 2002; Accreditation Criteria: Guidance for 
Industry, FDA Staff, and Third Parties,''

[[Page 22405]]

which repeats the AP criteria set out in section II of this document. 
In addition, the guidance provides other useful information such as 
suggestions about the format and content of the accreditation 
applications.
    The guidance represents the agency's current thinking on the 
``Implementation of the Inspection by Accredited Persons Program under 
the Medical Device User Fee and Modernization Act of 2002; 
Accreditation Criteria: Guidance for Industry, FDA Staff, and Third 
Parties.'' The issuance of this guidance is consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). 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 requirements of the applicable statutes and regulations.

IV. Paperwork Reduction Act of 1995

    This document and the guidance entitled ``Implementation of the 
Inspection by Accredited Persons Program under the Medical Device User 
Fee and Modernization Act of 2002; Accreditation Criteria: Guidance for 
Industry, FDA Staff, and Third Parties'' contain a proposed collection 
of information that requires clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995. In a document found 
elsewhere in this issue of the Federal Register, FDA is announcing that 
this proposed collection of information has been submitted to OMB for 
emergency processing. The document also solicits comments concerning 
the proposed collection of information.
    FDA will publish a separate document in the Federal Register 
announcing OMB's decision to approve, modify, or disapprove the 
information collection provisions contained in this document and the 
guidance. An agency may not conduct or sponsor, and a person is not 
required to respond to, a collection of information unless it displays 
a currently valid OMB control number.

V. Comments

    Interested persons may submit their written or electronic comments 
regarding the guidance at any time to Dockets Management Branch (see 
ADDRESSES). Submit either a single copy of the electronic comments to: 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments or send two paper copies of any 
mailed comments (individuals may submit only one copy). Identify 
comments with the docket number found in brackets in the heading of 
this document. Comments received will be made available in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

VI. Electronic Access

    To receive ``Implementation of the Inspection by Accredited Persons 
Program Under the Medical Device User Fee and Modernization Act of 
2002; Accreditation Criteria; Guidance for Industry, FDA Staff, and 
Third Parties'' by 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 (1200) 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 by 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 device safety alerts, 
Federal Register reprints, information on premarket submissions 
(including lists of approved applications and manufacturers' 
addresses), small manufacturer's assistance, information on video 
conferencing and electronic submissions, Mammography Matters, and other 
device-oriented information. The CDRH Web site may be accessed at 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh. A search capability for all CDRH
guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.
 Guidance documents are also available on the Dockets 
Management Branch Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.

    Dated: April 23, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-10415 Filed 4-23-03; 5:03 pm]

BILLING CODE 4160-01-S