[Federal Register Volume 64, Number 146 (Friday, July 30, 1999)]
[Notices]
[Pages 41443-41444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19531]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-1817]
Home Uterine Activity Monitors 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 guidance entitled ``Home Uterine Activity Monitors;
Guidance for the Submission of 510(k) Premarket Notifications.''
Elsewhere in this issue of the Federal Register, FDA is publishing a
notice of the panel recommendation to reclassify home uterine activity
monitors (HUAM's) into class II (special controls) and FDA's tentative
findings. FDA agrees that these monitors should be reclassified in
class II, and the guidance that is the subject of this notice of
availability is one of the special controls that FDA believes will
provide reasonable assurance of the safety and effectiveness of these
devices.
DATES: Submit written comments by October 28, 1999.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance entitled ``Home Uterine Activity Monitors;
Guidance for the Submission of 510(k) Premarket Notifications'' to the
Division of Small Manufacturers Assistance (HFZ-220), Center for
Devices and Radiological Health (CDRH), Food and Drug Administration,
1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive
label 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.
Submit written comments on the ``Home Uterine Activity Monitors;
Guidance for the Submission of 510(k) Premarket Notifications'' to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kathy Daws-Kopp, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1180, ext. 132.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance document describes a means by which HUAM's may comply
with the requirement of special controls for class II devices.
Designation of this guidance document as a special control means that
manufacturers attempting to establish that their device is
substantially equivalent to a predicate HUAM should demonstrate that
the proposed device complies with either the specific recommendations
of this guidance or some alternate control that provides equivalent
assurances of safety and effectiveness.
The guidance document addresses such areas as: Intended use and
indications for use; preclinical data including electrical safety
testing, electromagnetic compatibility, software, material safety, and
bench validation testing; clinical data; cleaning and disinfection; and
labeling.
In addition to this guidance document, FDA is also proposing that
patient registries be a special control for HUAM's.
II. Significance of Guidance
This guidance represents the agency's current thinking on premarket
notifications for HUAM'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
applicable statute, regulations, or both.
The agency has adopted good guidance practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This guidance is issued as a Level 1 guidance consistent with
GGP's.
III. Electronic Access
In order to receive ``Home Uterine Activity Monitors; Guidance for
the Submission of 510(k) Premarket Notifications'' 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 (820) 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 WWW.
Updated on a regular basis, the CDRH home page includes ``Home Uterine
Activity Monitors; Guidance for the Submission of 510(k) Premarket
Notifications,'' 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''.
IV. Comments
Interested persons may, on or before October 28, 1999, submit to
the Dockets Management Branch (address above) written comments
regarding this draft guidance. Two copies of any comments are to 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
[[Page 41444]]
document and received comments may be seen in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 30, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-19531 Filed 7-29-99; 8:45 am]
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