[Federal Register Volume 66, Number 47 (Friday, March 9, 2001)]
[Notices]
[Pages 14154-14155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5814]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-1817]


Final Guidance for Industry and FDA Reviewers: Class II Special 
Controls Guidance for Home Uterine Activity Monitors; 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 ``Final Guidance for Industry and 
FDA Reviewers: Class II Special Controls Guidance for Home Uterine 
Activity Monitors.'' This guidance describes the special controls FDA 
believes will provide reasonable assurance of the safety and 
effectiveness of these devices. Elsewhere in this issue of the Federal 
Register, FDA is publishing a final rule reclassifying the home uterine 
activity monitors (HUAM's) from class III to class II.

DATES: Submit written comments on agency guidances at any time.

ADDRESSES: Submit written requests for single copies on a 3.5 diskette 
of the guidance document entitled ``Final Guidance for Industry and FDA 
Reviewers: Class II Special Controls Guidance for Home Uterine Activity 
Monitors'' to the Division of Small Manufacturers Assistance (HFZ-220), 
Center for Devices and Radiological Health, 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. Submit written comments 
concerning this guidance to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852. 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: Colin M. Pollard, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1180.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance document describes a means by which manufacturers of 
HUAM's may comply with the requirements of special controls for class 
II devices. Designation of this guidance 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; labeling; design controls; clinical data; patient 
registry; preclinical data including electrical safety testing, 
electromagnetic compatibility, software, device accuracy, material 
safety, and cleaning and disinfection.
    This guidance document was issued for public comment in the Federal 
Register of July 30, 1999 (64 FR 41443), as a draft guidance entitled 
``Home Uterine Activity Monitors; Guidance for the Submission of 510(k) 
Premarket Notifications.'' The document has been modified from the 
original draft version for purposes of clarity and adding detail 
regarding the device description, bench testing, and design controls.

II. Significance of Guidance

    This guidance document 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), and 
published the final rule which set forth the agency's regulations for 
the development, issuance, and use of guidance documents (65 FR 56468, 
September 19, 2000). This guidance document is issued as a Level 1 
final guidance in accordance with the GGP regulations.

III. Electronic Access

    In order to receive ``Final Guidance for Industry and FDA 
Reviewers: Class II Special Controls Guidance for Home Uterine Activity 
Monitors'' via your fax machine, call the CDRH Facts-on-Demand system 
at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to 
enter the system. At the second voice prompt press 1 to order a 
document. Enter the document number (820) followed by the pound sign 
(#). Follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. CDRH maintains an entry on the Internet for easy 
access to information including text, graphics, and files that may be 
downloaded to a personal computer with access to the Internet. Updated 
on a regular basis, the CDRH home page includes ``Final Guidance for 
Industry and FDA Reviewers: Class II Special Controls Guidance for Home 
Uterine Activity Monitors,'' 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, at any time, submit written comments 
regarding the guidance to the Dockets Management Branch (address 
above). Such comments will be considered when determining whether to 
amend the current 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. A copy of the guidance and received comments are 
available for public examination in the Dockets

[[Page 14155]]

Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 31, 2001.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 01-5814 Filed 3-8-01; 8:45 am]
BILLING CODE 4160-01-F