[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; 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, 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,
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