[Federal Register Volume 61, Number 136 (Monday, July 15, 1996)]
[Notices]
[Pages 36888-36889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17829]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0200]
Bayer Corp.; Premarket Approval of Technicon Immuno 1
PSA Assay
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 Bayer Corp., Tarrytown, NY, for
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the
act), of Immuno 1 PSA Assay. FDA's Center for Devices and
Radiological Health (CDRH) notified the applicant, by letter of
December 22, 1995, of the approval of the application.
DATES: Petitions for administrative review by August 14, 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 Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Peter E. Maxim, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1293.
SUPPLEMENTARY INFORMATION: On June 27, 1995 Bayer Corp., Tarrytown, NY
10591, submitted to CDRH an application for premarket approval of
Immuno 1 PSA Assay. This device is an in vitro diagnostic
device intended to quantitatively measure prostate specific antigen
(PSA) in human serum on the Technicon Immuno 1 system. PSA
values obtained should be used as an aid in the management (monitoring)
of prostate cancer patients. This diagnostic method is not intended for
use on any other system.-
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
Immunology 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 December 22, 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 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 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 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 14, 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).
[[Page 36889]]
Dated: April 9, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-17829 Filed 7-12-96; 8:45 am]
BILLING CODE 4160-01-F
