[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]
BILLING CODE 4160-01-F