[Federal Register Volume 59, Number 207 (Thursday, October 27, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-26673]
[[Page Unknown]]
[Federal Register: October 27, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0349]
Ciba Corning Corp.; Premarket Approval of ACSTM PSA +D
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 Ciba Corning Corp., Medfield, MA, for
premarket approval, under section 515 of the Federal Food, Drug, and
Cosmetic Act (the act), of ASCTM PSA +D. FDA's Center for Devices
and Radiological Health (CDRH) notified the applicant, by letter on
September 2, 1994, of the approval of the application.
DATES: Petitions for administrative review by November 28, 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, 2098
Gaither Rd., Rockville, MD 20850, 301-594-1293.
SUPPLEMENTARY INFORMATION: On June 26, 1992, Ciba Corning Diagnostics
Corp., Medfield, MA 02052-1688, submitted to CDRH an application for
premarket approval of ASCTM PSA +D. The device is a two-site
chemiluminometric assay and is indicated for the quantitative, serial
determination of prostate-specific antigen (PSA) in serum and to aid in
the management of patients with prostate cancer using the Ciba Corning
Automated Chemiluminescence System (ACS). 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 PMA was not
referred to the Immunology Devices Panel, an FDA advisory panel, for
review and recommendation because the information in the PMA
substantially duplicates information previously reviewed by this panel.
On September 2, 1994, 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 (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 28, 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 13, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 94-26673 Filed 10-26-94; 8:45 am]
BILLING CODE 4160-01-F
