[Federal Register Volume 62, Number 66 (Monday, April 7, 1997)]
[Notices]
[Page 16593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-8707]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97M-0124]


COOK OB/GYN<Register>; Humanitarian Device Exemption Approval of 
Harrison Fetal Bladder Stent Set (Lowery Modification)

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 humanitarian device exemption (HDE) application by COOK 
OB/GYN<Register>, Spencer, IN, under the Federal Food, Drug, and 
Cosmetic Act (the act) of the Harrison Fetal Bladder Stent Set (Lowery 
Modification).

DATES: Petitions for administrative review by May 7, 1997.

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

FOR FURTHER INFORMATION CONTACT: Donna-Bea Tillman, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1180.

SUPPLEMENTARY INFORMATION: On November 13, 1996, COOK OB/GYN<Register>, 
Spencer, IN 47460, submitted to CDRH an application for an HDE for the 
Harrison Fetal Bladder Stent Set (Lowery Modification). The device is a 
fetal bladder stent and is indicated for fetal urinary tract 
decompression following the diagnosis of fetal postvesicular 
obstructive uropathy in fetuses 18 to 32 weeks gestational age.
    In accordance with 21 CFR 814.116(a), this HDE was not referred to 
the Obstetrics and Gynecology Devices Panel, an FDA advisory committee, 
for review and recommendation because the information in the HDE 
substantially duplicates information previously reviewed by this panel.
    On February 14, 1997, 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 probable benefit upon which CDRH based 
its approval is on file in the Dockets Management Branch (address 
above) and is available from the 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 (21 U.S.C. 360e(d)(3)) 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 21 CFR part 12 of 
FDA's administrative practices and procedures 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 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(s) to be reviewed, 
the form of 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 May 7, 1997, 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 petitioners may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.
    This notice is issued under section 520(h) of the act (21 U.S.C. 
360j(h)), 21 CFR 814.116(b), 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: February 20, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-8707 Filed 4-4-97; 8:45 am]
BILLING CODE 4160-01-F