[Federal Register Volume 62, Number 125 (Monday, June 30, 1997)]
[Notices]
[Pages 35212-35213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17065]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97M-0254]


Cytyc Corp. Premarket Approval Of ThinPrep 2000 
Processor

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 Cytyc Corp., Marlborough, MA, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of the ThinPrep 2000 System. After reviewing the 
recommendation of the Hematology and Pathology Devices Panel, FDA's 
Center for Devices and Radiological Health (CDRH) notified the 
applicant, by letter of May 20, 1996, of the approval of the 
application.

DATES: Petitions for administrative review by July 30, 1997.

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, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-1293.

SUPPLEMENTARY INFORMATION: On November 22, 1995, Cytyc Corp., 
Marlborough, MA 01752, submitted to CDRH an application for premarket 
approval of the ThinPrep 2000 System. The device is an 
automated cytology slide preparation instrument and is intended as a 
replacement for the conventional method of pap smear preparation for 
use in screening for the presence of atypical cells, cervical cancer, 
or its precursor lesions (Low Grade Squamous Intraepithelial Lesions, 
High Grade Squamous Intraepithelial Lesions), as well as all other 
cytologic categories as defined by The Bethesda System for Reporting 
Cervical/Vaginal Cytologic Diagnoses.
    On June 7, 1993, the Hematology and Pathology Devices Panel of the 
Medical Devices Advisory Committee, an FDA advisory committee, reviewed 
and recommended approval of the application. Cytyc Corp. withdrew the 
application and subsequently resubmitted the application on November 
22, 1995.
    On May 20, 1996, 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 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 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 the 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 July 30, 1997, 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.

[[Page 35213]]

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: June 5, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-17065 Filed 6-27-97; 8:45 am]
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