[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availability of the draft guidance entitled ``Modifications To Devices 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 This draft guidance is neither final nor is it in effect at 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 The draft guidance includes a flowchart model that could be 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DATES: Written comments concerning this draft guidance must be received 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Modifications To Devices Subject To 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 Written comments concerning this draft 
guidance must be submitted to the Dockets Management Branch, (HFA-305), 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Information section for information on electronic access to the draft 
guidance.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 <a href="http://www.fda.gov/
cdrh">http://www.fda.gov/
cdrh</a>.
    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