[Federal Register Volume 63, Number 90 (Monday, May 11, 1998)]
[Notices]
[Page 25865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12311]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0362]
The New 510(k) Paradigm; Alternate Approaches to Demonstrating
Substantial Equivalence in Premarket Notifications; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance entitled ``The New 510(k) Paradigm-Alternate
Approaches to Demonstrating Substantial Equivalence in Premarket
Notifications.'' The New 510(k) Paradigm presents two alternative
methods, in addition to the traditional method, of demonstrating
substantial equivalence in premarket notifications and is intended to
conserve FDA's review resources while facilitating the introduction of
safe and effective devices into interstate commerce. The New 510(k)
Paradigm addresses the type of information needed in premarket
notification submissions, by the Center for Devices and Radiological
Health (CDRH), to render substantial equivalence determinations.
DATES: May 11, 1998.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of ``The New 510(k) Paradigm-Alternate Approaches to
Demonstrating Substantial Equivalence in Premarket Notifications,'' 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. 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 guidance.
FOR FURTHER INFORMATION CONTACT: Philip J. Phillips, Center for Devices
and Radiological Health (HFZ-400), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2022.
SUPPLEMENTARY INFORMATION:
I. Background
Under section 510(k) of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360(k)), a person who intends to introduce a
device into commercial distribution is required to submit a premarket
notification, or 510(k), to FDA at least 90 days before commercial
distribution is to begin. Section 513(i) of the act (21 U.S.C. 360c(i))
states that FDA may issue an order of substantial equivalence, only
upon making a determination that the device to be introduced into
commercial distribution is as safe and effective as a legally marketed
device. Under 21 CFR 807.87, FDA has codified the content requirements
for premarket notifications to be submitted by device manufacturers in
support of a substantial equivalence decision. FDA has, however,
discretion in the type of information it deems necessary to meet those
content requirements.
While the Paradigm maintains the traditional method of
demonstrating substantial equivalence under section 510(k) of the act,
it also presents two alternatives. The first alternative, the ``Special
510(k): Device Modification,'' utilizes certain aspects of the Quality
System regulation, while the second alternative, the ``Abbreviated
510(k),'' relies on the use of FDA guidance documents, special controls
and FDA recognized consensus standards to facilitate 510(k) review.
In the Federal Register of September 19, 1997 (62 FR 49247), FDA
published a notice of availability of a draft of this guidance document
on the Paradigm. FDA received 13 comments on the draft. FDA reviewed
these comments and has made revisions to the guidance as appropriate.
This guidance document represents the agency's current thinking on
the 510(k) Paradigm. 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
applicable statute, regulations, or both.
II. Electronic Access
In order to receive ``A New 510(k) Paradigm-Alternate Approaches to
Demonstrating Substantial Equivalence in Premarket Notifications,'' 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 905 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: 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.
III. Comments
Interested persons may, at any time, submit to the contact person
named above written comments regarding this guidance document. Comments
will be considered in determining whether to revise or revoke the
guidance.
Dated: May 1, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-12311 Filed 5-8-98; 8:45 am]
BILLING CODE 4160-01-F