[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availability of a draft guidance entitled ``PMA/510(k) Expedited Review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