[Federal Register: February 3, 2003 (Volume 68, Number 22)]
[Notices]
[Page 5298-5299]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03fe03-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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
time.
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.
SUPPLEMENTARY INFORMATION:
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
request.
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://www.fda.gov/cdrh. The guidance entitled ``Quality
System Information for Certain Premarket Application Reviews'' will be
available at 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]
BILLING CODE 4160-01-S