[Federal Register Volume 62, Number 167 (Thursday, August 28, 1997)]
[Notices]
[Pages 45671-45672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22855]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0349]


Convenience Kits Interim Regulatory Guidance; 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 document entitled ``Convenience Kits Interim 
Regulatory Guidance.'' The guidance is final and in effect at this 
time. This guidance applies to convenience kits and provides guidance 
regarding FDA's intent to exercise enforcement discretion with respect 
to premarket notification requirements under the Federal Food, Drug, 
and Cosmetic Act (the act), and describes FDA's intent to propose 
rulemaking to exempt certain convenience kits from premarket 
notification requirements. The guidance addresses the type of data 
needed by the Center for Devices and Radiological Health (CDRH) to 
decrease the number of 510(k) submissions for convenience kits, saving 
Office of Device Evaluation (ODE) review resources. The agency is 
inviting public comment on this guidance.

DATES: Submit written comments on this guidance at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
entitled ``Convenience Kits Interim Regulatory Guidance'' to the Office 
of Device Evaluation, Center for Devices and Radiological Health, Food 
and Drug Administration, 9200 Corporate Blvd., Rockville MD 20850. Send 
two self-addressed adhesive labels to assist that office in processing 
your request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance. Submit written comments on the guidance to the 
contact person listed below.

FOR FURTHER INFORMATION CONTACT: Heather Rosecrans, Office of Device 
Evaluation (HFZ-404), Center for Devices and Radiological Health, Food 
and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 
301-594-1190.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance represents a final document that describes a new 
regulatory approach to be applied to convenience kits that could result 
in a decrease in the number of 510(k) submissions for these devices 
and, in so doing, will save FDA review resources.
    Under section 510(k) of the act (21 U.S.C. 360(k)), first time 
marketers of devices must submit a premarket notification and obtain 
clearance for a device before it can be lawfully introduced into 
interstate commerce. Many convenience kits that have been subject to 
510(k) review are comprised of legally marketed devices that are simply 
being assembled in kit form strictly for the ``convenience'' of the 
purchaser.
    FDA believes that under certain circumstances, premarket clearance 
for convenience kits may not be necessary to ensure protection of the 
public health. Accordingly, FDA intends to propose rulemaking to exempt 
certain, specifically identified convenience kits from the requirement 
of premarket notification. Until such rule is in effect, FDA intends to 
exercise enforcement discretion regarding the requirement for

[[Page 45672]]

premarket clearance for convenience kits that have intended uses, 
components, and processing methods that are described in the guidance, 
and where the assembler/manufacturer is able to reasonably conclude 
that any further processing of the kit and its components does not 
significantly affect the safety or effectiveness of any of its 
components. The intent to exercise enforcement discretion means that 
FDA does not intend to take enforcement action for the failure to 
submit premarket notification for convenience kits described in the 
guidance. In the future, FDA intends to propose rulemaking to formally 
exempt these types of kits from the requirement of premarket 
notification.
    This guidance is effective immediately.
    The ``Convenience Kits Interim Regulatory Guidance'' represents the 
agency's current thinking on premarket notification regulatory strategy 
for convenience kits. 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.

II. Electronic Access

    In order to receive the ``Convenience Kits Interim Regulatory 
Guidance'' document 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 
the second voice prompt press 2, and then enter the document number 562 
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 do so by 
using the World Wide Web (WWW). The Center for Devices and Radiological 
Health (CDRH) maintains an entry on the WWW for easy access to 
information including text, graphics, and files that may be downloaded 
to a PC with access to the Web. The CDRH home page is updated on a 
regular basis and includes the ``Convenience Kits Interim Regulatory 
Guidance'' document, 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>''. The ``Convenience Kits Interim Regulatory 
Guidance'' is available on the medical device reporting page at 
``http://www.fda.gov/cdrh/ode/convkit.html''.
    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. Request for Comments

    Interested persons may, at any time, submit to the contact person 
listed above written comments regarding this guidance.

    Dated: August 21, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-22855 Filed 8-27-97; 8:45 am]
BILLING CODE 4160-01-F