[Federal Register Volume 59, Number 198 (Friday, October 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25516]
[[Page Unknown]]
[Federal Register: October 14, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0327]
Hybritech Inc.; Premarket Approval of Tandem-R, E, and
ERA PSA Assays
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 supplemental application by Hybritech, Inc., San Diego,
CA, for premarket approval, under the Federal Food, Drug, and Cosmetic
Act (the act), of Tandem-R, E, and ERA PSA Assays. After
reviewing the recommendation of the Immunology Devices Panel, FDA's
Center for Devices and Radiological Health (CDRH) notified the
applicant, by letter of August 25, 1994, of the approval of the
supplemental application.
DATES: Petitions for administrative review by November 14, 1994.
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, rm.
1-23, 12420 Parklawn Dr., Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Peter E. Maxim, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 1390
Piccard Dr., Rockville, MD 20850, 301-594-1293.
SUPPLEMENTARY INFORMATION: On June 29, 1992, Hybritech Inc., San Diego,
CA 92196-9006, submitted to CDRH a supplemental application for
premarket approval of Tandem-R, E, and ERA PSA Assays. These
devices were originally approved for use as an aid in the prognosis and
management of patients with prostate cancer. The supplemental PMA
application is for a modification of the intended use for all three
formats to read as follows: The Tandem-R PSA
Immunoradiometric Assay, Tandem-E PSA Immunoenzymetric Assay,
or Tandem-ERA PSA Immunoenzymetric Assay,
* * * is an In Vitro device for the quantitative measurement of
prostate-specific antigen (PSA) in human serum. This device is
indicated for the measurement of serum PSA in conjunction with
digital rectal examination (DRE) as an aid in the detection of
prostate cancer in men aged 50 years or older. Prostatic biopsy is
required for diagnosis of cancer. This device is further indicated
for the serial measurement of PSA to aid in the prognosis and
management of patients with prostate cancer.
On June 29, 1993, the Immunology Devices Panel of the Medical
Devices Advisory Committee, an FDA advisory committee, reviewed and
recommended approval of the supplemental application. On August 25,
1994, CDRH approved the supplemental 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 (21 U.S.C. 360e(d)(3)) authorizes any
interested person to petition, under section 515(g) of the act (21
U.S.C. 360e(g)), 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 November 14, 1994, 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: October 3, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 94-25516 Filed 10-13-94; 8:45 am]
BILLING CODE 4160-01-F