[Federal Register Volume 61, Number 139 (Thursday, July 18, 1996)]
[Notices]
[Pages 37484-37485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-18286]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0220]


Healthdyne, Inc.; Premarket Approval of System 37 Home 
Uterine Activity Monitoring System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
approval of the application by Healthdyne, Inc., Marietta, GA 30067, 
for premarket approval, under section 515 of the Federal Food, Drug, 
and Cosmetic Act (the act), of System 37 Home Uterine 
Activity Monitoring System. FDA's Center for Devices and Radiological 
Health (CDRH) notified the applicant, by letter on September 29, 1995, 
of the approval of the application.
DATES: Petitions for administrative review by August 19, 1996.

ADDRESSES: Written requests for copies of the summary of safety and 
effectiveness data and petitions for administrative review to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Drive, rm. 1-23,Rockville, MD 20857.

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: On July 24, 1992, Healthdyne, Inc., 
Marietta, GA 30067, submitted to CDRH an application for premarket 
approval of System 37 Home Uterine Activity Monitoring 
System. The device is a Home Uterine Activity Monitor and is indicated 
for use, in conjunction with standard high risk care, for the daily at-
home measurement of uterine activity in pregnancies  24 
weeks gestation for women with previous preterm delivery. Uterine 
activity data are displayed at a remote location to aid in the early 
detection of preterm labor.

[[Page 37485]]

     In accordance with the provisions of section 515(c)(2) of the act 
(21 U.S.C. 360e(c)(2)) as amended by the Safe Medical Devices Act of 
1990, this premarket approval application (PMA) was not referred to the 
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory 
Committee, an FDA advisory committee, for review and recommendation 
because the information in the PMA substantially duplicates information 
previously reviewed by this panel.
    -On September 29, 1995, CDRH approved the application by a letter 
to the applicant from the Director of the Office of Device Evaluation, 
CDRH.
    -A summary of the safety and effectiveness data on which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from that office upon written request. Requests 
should be identified with the name of the device and the docket number 
found in brackets in the heading of this document.

-Opportunity for Administrative Review

    -Section 515(d)(3) of the act authorizes any interested person to 
petition, under section 515(g) of the act, for administrative review of 
CDRH's decision to approve this application. A petitioner may request 
either a formal hearing under part 12 (21 CFR part 12) of FDA's 
administrative practices and regulations or a review of the application 
and CDRH's action by an independent advisory committee of experts. A 
petition is to be in the form of a petition for reconsideration under 
Sec. 10.33(b) (21 CFR 10.33(b)). A petitioner shall identify the form 
of review requested (hearing or independent advisory committee) and 
shall submit with the petition supporting data and information showing 
that there is a genuine and substantial issue of material fact for 
resolution through administrative review. After reviewing the petition, 
FDA will decide whether to grant or deny the petition and will publish 
a notice of its decision in the Federal Register. If FDA grants the 
petition, the notice will state the issue to be reviewed, the form of 
the review to be used, the persons who may participate in the review, 
the time and place where the review will occur, and other details.
    -Petitioners may, at any time on or before August 19, 1996, file 
with the Dockets Management Branch (address above) two copies of each 
petition and supporting data and information, identified with the name 
of the device and the docket number found in brackets in the heading of 
this document. Received petitions may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    -This notice is issued under the Federal Food, Drug, and Cosmetic 
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under 
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10) 
and redelegated to the Director, Center for Devices and Radiological 
Health (21 CFR 5.53).

    Dated: June 21, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-18286 Filed 7-17-96; 8:45 am]
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