[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]


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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.

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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