[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 ``http://
www.fda.gov/cdrh''. 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