[Federal Register Volume 63, Number 151 (Thursday, August 6, 1998)]
[Notices]
[Pages 42053-42054]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20958]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0519]
Draft Modifications To Devices Subject To Premarket Approval--The
PMA Supplement Decision Making Process; 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availability of the draft guidance entitled ``Modifications To Devices
Subject To Premarket Approval--The PMA Supplement Decision Making
Process.'' This draft guidance is neither final nor is it in effect at
this time. The draft guidance includes a flowchart model that could be
used by premarket approval application (PMA) holders in their
decisionmaking to analyze whether certain changes in a device affect
the safety or effectiveness of the device, and therefore, require
submission of a new PMA, PMA supplement, alternate submission to a PMA
supplement, annual report or documentation in the PMA holders' files on
the device.
DATES: Written comments concerning this draft guidance must be received
by November 4, 1998.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Modifications To Devices Subject To
Premarket Approval--The PMA Supplement Decision Making Process'' to the
Division of Small Manufacturers 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. Written comments concerning this draft
guidance must be submitted to the Dockets Management Branch, (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Comments should be identified with the docket number found in
brackets in the heading of this document. See the Supplementary
Information section for information on electronic access to the draft
guidance.
FOR FURTHER INFORMATION CONTACT: Kathy M. Poneleit, Center for Devices
and Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2186.
SUPPLEMENTARY INFORMATION:
I.Background
In January 1997, FDA released a guidance document entitled
``Deciding When to Submit a 510(k) for a Change to an Existing
Device.'' This document was an effort to clarify current practice and
FDA's expectations regarding the process used to determine whether a
change to a class I or II device or to a class III device for which
premarket approval had not yet been required under section 515(b) of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(b)),
required submission of a new 510(k).
Class III devices subject to premarket approval requirements under
section 515 of the act were not addressed by that document and the PMA
regulation, part 814 (21 CFR part 814), provides only general criteria
for determining whether a PMA supplement is required for a particular
device change. FDA's process of developing specific guidance on
submission of PMA supplements coincided with FDA reengineering
activities, including the CDRH effort to streamline the PMA supplement
process within the context of the existing premarket approval
regulation (part 814).
The draft guidance has been developed to aid PMA holders who
[[Page 42054]]
intend to modify their device and are in the process of deciding the
type of documentation and/or submission necessary for that particular
modification. The draft guidance concerning changes to an existing
device is intended to complement, not supplant, existing guidances on
the premarket approval process. It is not intended to apply to
combination products, such as drug/device or biologic/device
combinations.
This draft guidance incorporates three separate flowcharts for in
vitro diagnostic devices (IVD's). These flowcharts cover changes in
technology or performance, change assessment, and materials changes for
IVD's. This draft guidance applies to in vitro diagnostic devices
regulated by the CDRH and application of this guidance to in vitro
diagnostic devices regulated under premarket approval by the Center for
Biologics Evaluation and Research (CBER) should be discussed with CBER.
The types of modifications addressed in the draft guidance include
changes in device design, device labeling, device materials, and the
manufacturing process for the device. This draft guidance can also be
applied to situations when a legally marketed device is the subject of
a recall and a change is indicated to assure the safety and
effectiveness of the device.
When contemplating changes to any approved device, PMA holders
should use the flowchart for ``each'' type of proposed change. In those
circumstances where the proposed change is not addressed in the
flowchart or in a device-specific guidance document, PMA holders are
encouraged to contact the Office of Device Evaluation (ODE) in CDRH for
additional information.
II. Significance of Guidance
This draft guidance document represents the agency's current
thinking on modifications to devices which are subject to premarket
approval. This draft guidance 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 (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This guidance document is issued as a Level 1 guidance
consistent with GGP's.
III. Electronic Access
In order to receive ``Modifications To Devices Subject To Premarket
Approval--The PMA Supplement Decision Making Process'' 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 second voice prompt press 2, and then
enter the document number (855) followed by the pound sign (#). Then
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 World Wide Web (WWW). CDRH maintains an entry on
the WWW for easy access to information including text, graphics, and
files that may be downloaded to a personal computer with access to the
Web. Updated on a regular basis, the CDRH home page includes
``Modifications To Devices Subject To Premarket Approval--The PMA
Supplement Decision Making Process,'' 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.
A text-only version of the CDRH Web site is also available from a
computer or VT-100 compatible terminal by dialing 800-222-0185
(terminal settings are 8/1/N). Once the modem answers, press Enter
several times and then select menu choice 1: FDA BULLETIN BOARD
SERVICE. From there follow instructions for logging in, and at the BBS
TOPICS PAGE, arrow down to the FDA home page (do not select the first
CDRH entry). Then select Medical Devices and Radiological Health. From
there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general
information, or arrow down for specific topics.
IV. Comments
Interested persons may, on or before November 4, 1998, submit to
Dockets Management Branch (address above) written comments regarding
this draft 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 draft 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: July 22, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-20958 Filed 8-5-98; 8:45 am]
BILLING CODE 4160-01-F
