[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