[Federal Register Volume 59, Number 218 (Monday, November 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27925]
[[Page Unknown]]
[Federal Register: November 14, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94M-0362]
CIBA Corning Diagnostics Corp.; Premarket Approval of ACSTM
CEA 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 Ciba Corning Corp., Medfield, MA, for
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the
act), of the ACSTM CEA Assay. FDA's Center for Devices and
Radiological Health (CDRH) notified the applicant by letter of August
23, 1994, of the approval of the application.
DATES: Petitions for administrative review by December 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 23, 1993, Ciba Corning Diagnostics
Corp., Medfield, MA 02052-1688, submitted to CDRH an application for
premarket approval of the ACSTM CEA Assay. The device is an in
vitro device for the quantitative measurement of carcinoembryonic
antigen (CEA) in human serum to aid in the management of cancer
patients in whom changing concentrations of cea are observed, 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 (Pub. L. 101-629), 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 August 23, 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, 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 (insert date 30 days
after date of publication in the Federal Register), 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 27, 1994.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 94-27925 Filed 11-10-94; 8:45 am]
BILLING CODE 4160-01-F