[Federal Register Volume 63, Number 61 (Tuesday, March 31, 1998)]
[Notices]
[Pages 15427-15428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-8300]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0173]


PMA/510(k) Expedited Review Guidance for Industry and Center for 
Devices and Radiological Health Staff; 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availability of a draft guidance entitled ``PMA/510(k) Expedited Review 
Guidance for Industry and the Center for Devices and Radiological 
Health (CDRH) Staff.'' FDA believes it is in the interest of the public 
health to review premarket approval applications (PMA's) and premarket 
notifications (510(k)'s) for certain medical devices in an expedited 
manner. The expedited review will generally be considered when a device 
offers a potential for clinically meaningful benefit as compared to the 
existing alternatives (preventive, diagnostic, or therapeutic) or when 
the new medical device promises to provide a revolutionary advance (not 
incremental advantage) over currently available alternative modalities.

DATES: Submit written comments concerning this guidance by June 29, 
1998. After the close of the comment period, written comments may be 
submitted at any time to one of the contact persons listed in this 
document.

ADDRESSES: Written comments concerning this guidance that are submitted 
within the 90-day comment period must be submitted to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Comments should be 
identified with the docket number found in brackets in the heading of 
this document. Submit written requests for single copies of the 
guidance on a 3.5'' diskette to the Division of Small Manufacturers 
Assistance (DSMA), Center for Devices and Radiological Health (HFZ-
220), 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 for information on electronic access 
to the guidance.

FOR FURTHER INFORMATION CONTACT:
    On expedited review for PMA's: Kathy M. Poneleit, Center for 
Devices and Radiological Health (HFZ-402), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
2186.
    For expedited review for 510(k)'s: Heather S. Rosecrans, Center for 
Devices and Radiological Health (HFZ-402), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1190.

SUPPLEMENTARY INFORMATION:

I. Background

    The criteria and procedures under which expedited review would 
apply to PMA's and Premarket Notifications (510(k)'s) for medical 
devices were previously identified in General Program Memorandum 
#G94-2, ``PMA/510(k) Expedited Review.'' In order to reflect 
the criteria in section 515(d)(5) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360e(d)(5)), as modified by section 202 of the 
Food and Drug Administration Modernization Act of 1997 (FDAMA) entitled 
``Special Review for Certain Devices,'' the criteria section of the 
guidance has been modified. These modifications include rearranging the 
first three criteria and revising the fourth to track the new statutory 
language more closely. All other sections of the guidance remain the 
same. This document rescinds and replaces General Program Memorandum 
#G94-2, ``PMA/510(k) Expedited Review.''
    These procedures are based upon the Management Action Plan 
initiative paper entitled ``PMA/510(k) Expedited Review Process.'' This 
guidance embodies the procedures flowing from that issue paper and 
implements the principles in that document as the policy of the Office 
of Device Evaluation (ODE). This Blue Book Memorandum will be used by 
ODE reviewers in applying procedures for the review of incoming PMA's 
and 510(k)'s.
    FDA believes it is in the interest of the public health to review 
PMA's and 510(k)'s for certain medical devices in an expedited manner. 
Expedited review will generally be considered when a device offers a 
potential for clinically meaningful benefit as compared to the existing 
alternatives (preventative, diagnostic, or therapeutic) or when the new 
medical device promises to provide a revolutionary advance (not 
incremental advantage) over currently available alternative modalities.
    Granting of expedited review status means that the marketing 
application would receive priority review before other pending PMA's 
and 510(k)'s, i.e., the application will be placed at the beginning of 
the appropriate review queue. If multiple applications for the same 
type of medical device offering comparable advantage over existing 
approved alternatives have been granted expedited review, the 
applications will be reviewed with priority according to their 
respective submission due dates. Once one of the applications is 
approved, those of the same type still pending will generally lose 
their expedited review status with regard to review resources but will 
retain their place in the review queue.

II. Significance of Guidance

    This guidance document represents the agency's current thinking on 
the procedures to be followed for expedited review of PMA's and 
(510(k)'s). 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, regulations, or both.
    This guidance document entitled ``PMA/510(k) Expedited Review 
Guidance for Industry and CDRH Staff'' is a Level 1 guidance under 
FDA's Good

[[Page 15428]]

Guidance Practice Policy. Public comment prior to implementation of the 
guidance document is not required because the guidance is needed to 
implement new statutory requirements enacted by FDAMA.

III. Electronic Access

    In order to receive the guidance entitled ``PMA/510(k) Expedited 
Review Guidance for Industry and CDRH Staff'' via your fax machine, 
call the CDRH Facts-On-Demand 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 108, followed by the pound sign (). 
Then follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the 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 the ``PMA/
510(k) Expedited Review Guidance,'' 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 ``PMA/510(k) Expedited Review Guidance'' will be available 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 BULLENTIN 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 June 29, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
this guidance document. Two copies of any comments are 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 guidance document and received comments may be seen 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday. After June 29, 1998, written comments may be submitted 
at any time to one of the contact persons in this document.

    Dated: March 25, 1998.
 D.B. Burlington,
 Director, Center for Devices and Radiological Health.
[FR Doc. 98-8300 Filed 3-30-98; 8:45 am]
BILLING CODE 4160-01-F