[Federal Register: February 3, 2003 (Volume 68, Number 22)]
[Page 5298-5299]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 99D-2212]

Medical Devices; Final Guidance on Quality System Information for 
Certain Premarket Application Reviews; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance entitled ``Quality System Information 
for Certain Premarket Application Reviews.'' This guidance has been 
prepared by the Center for Devices and Radiological Health (CDRH), in 
coordination with the Center for Biologics Evaluation and Research 
(CBER), to assist medical device manufacturers in preparing and 
maintaining the quality system (QS) information required in certain 
premarket submissions.

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

ADDRESSES: 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 final guidance document entitled 
``Quality System Information for Certain Premarket Application 
Reviews'' to the Division of Small Manufacturers, International and 
Consumer 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: Kimberly A. Trautman, Center for 
Devices and Radiological Health (HFZ-340), Food and Drug 
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-4648, or 
Leonard Wilson, Center for Biologics Evaluation and Research (HFM-25), 
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-
1448, 301-827-0373.


I. Background

    This level 1 guidance entitled ``Quality System Information for 
Certain Premarket Application Reviews'' provides guidance to 
manufacturers who prepare and maintain QS information that should be 
included in premarket approval applications (PMA), PMA supplements, 
product development protocols (PDP), humanitarian device exemptions 
(HDE), and modular review submissions. This QS information guidance is 
meant to assist applicants in providing the information in a clear 
format for efficient review and timely decisions.
    CDRH first published a guidance document entitled ``Guidance for 
Preparation of PMA Manufacturing Information'' on March 22, 1991, that 
was modified in 1992. The 1992 document was incorporated into the 
``Regulatory Requirements for Medical Devices: A Workshop Manual.'' 
Feedback from industry and FDA reviewers, as well as revisions to the 
regulation in 1996, prompted this revision to the guidance.
    This guidance entitled ``Quality System Information for Certain 
Premarket Application Reviews'' replaces the 1991 and 1992 guidance 
documents concerning the kind of good manufacturing practice (GMP) 
information that should be submitted in premarket submissions before an 
inspection is conducted as part of the premarket approval process. The 
document should be used for PMA, PMA supplements, PDP, HDE, and modular 
review applications. The information identified in this guidance 
addresses the current GMP requirements found in the quality system 
regulation (see 21 CFR part 820).
    Applicants who use this guidance should be able to focus their 
submissions on the information CDRH and CBER need to review. Based on 
their review, CDRH and CBER will provide to FDA field staff 
inspectional guidance to plan the premarket approval inspection. This 
should reduce the amount of time the investigator will need to conduct 
the onsite inspection.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices (GGPs) regulation (21 CFR 10.115). The guidance represents 
the agency's current thinking on QS

[[Page 5299]]

information for certain premarket application reviews. 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 statute and 
regulations. This guidance document is issued as a level 1 guidance 
consistent with GGPs.
    This guidance, when used in conjunction with the QS regulation, 
illustrates an approach for complying with the content requirements for 
premarket submissions found in section 515(c) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(c)) and 21 CFR part 
814. A manufacturer who chooses to meet application requirements for 
the QS information in an alternative way may wish to consult with the 
appropriate office prior to the submission. The FDA staff can help 
identify areas that might raise particular concerns for CDRH and CBER 
reviewers or investigators.

III. Comments from the Draft Guidance

    In the Federal Register of August 3, 1999 (64 FR 42137), ``Medical 
Devices, Draft Guidance on Quality System Regulation Information for 
Various Premarket Submissions; Availability'' was published as a draft 
level 1 guidance document for comment under GGPs. Six individuals or 
organizations filed comments on the draft guidance.
    Most of the comments requested a better understanding of how FDA 
used the information previously submitted under the GMP manufacturing 
section and how the information requested in this guidance would be 
used. The introduction of the final guidance document explains that 
CDRH's Office of Compliance (OC) will review the QS information 
submitted in the premarket application at the same time the Office of 
Device Evaluation (ODE) reviews the other portions of the application. 
The appropriate offices in CBER will review the QS information 
submitted in CBER-regulated premarket submissions. Applicants who use 
this guidance should be able to focus their submissions on the 
information CDRH/CBER will need for review. Based on their review, 
CDRH/CBER will provide inspectional guidance to FDA field staff. 
Submission of this information can help focus the preapproval 
inspection process and limit the amount of time field staff will need 
to spend in the facility.
    A few comments questioned the recommendation that manufacturers 
have design control information available, upon request, for devices 
subject to 510(k) clearance because it suggested that such 
documentation could be requested as part of the determination of 
substantial equivalence. FDA agrees with the comments and, therefore, 
has limited the applicability of this guidance document to exclude 
510(k) submissions.
    A few comments questioned whether the draft guidance document 
exceeded requirements in the QS regulation. The introduction to the 
final guidance document explains that the guidance document requests 
copies of written procedures or lists of items related to the QS 
regulation. In most cases, these procedures or lists are explicitly 
required under provisions of the QS regulation. In a few cases, the 
explanations or lists will facilitate FDA's review of your QS 
information. In the cases where the information is not explicitly 
required under statute or regulation (e.g., production flow diagram, 
list of any standards used, process validation master plan), FDA 
believes the information is the type you are likely to create and 
maintain as part of your QS. FDA believes submission of such 
information as part of your application will reduce or eliminate the 
need for us to request additional information during our review and 
preapproval inspection. However, because this is a guidance document, 
compliance with the recommendation is not required.
    The final guidance also incorporates many editorial comments and 
wording suggestions that were submitted by comments.

IV. Electronic Access

    In order to receive the guidance document ``Quality System 
Information for Certain Premarket Application Reviews `` via your fax 
machine, call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 
301-827-0111 from a touch-tone telephone. At the first voice prompt 
press 1 to access DSMA Facts, at the second voice prompt press 2, and 
then enter the document number (1140) followed by the pound sign 
([numsign]). Then follow the remaining voice prompts to complete your 
    Persons interested in obtaining a copy of the document 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 access to the Internet. 
Updated on a regular basis, the CDRH home page includes the ``Quality 
System Information for Certain Premarket Application Reviews,'' 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh. The guidance entitled ``Quality 
System Information for Certain Premarket Application Reviews'' will be 
available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/comp/guidance/1140.pdf.

V. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520) . 
The collections of information addressed in the guidance document have 
been approved by OMB in accordance with the PRA under the regulations 
governing premarket approval applications (21 CFR part 814, OMB control 
number 0910-0231) and the regulations governing quality systems (21 CFR 
part 820, OMB control number 0910-0073).

VI. Comments

    Interested parties may submit to Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this guidance. 
Submit two copies of any mailed 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: January 10, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-2375 Filed 1-31-03; 8:45 am]