[Federal Register Volume 61, Number 185 (Monday, September 23, 1996)]
[Notices]
[Pages 49780-49781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24364]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96M-0332]


Neopath, Inc.; Premarket Approval of the AutoPap 300 QC 
System

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 Neopath, Inc., Redmond, WA, for 
premarket approval, under the Federal Food, Drug, and Cosmetic Act (the 
act), of the AutoPap 300 QC 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 September 29, 1995, of the approval of the 
application.

DATES: Petitions for administrative review by October 23, 1996.
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 February 24, 1995, Neopath, Inc., 
Redmond, WA 98052, submitted to CDRH an application for premarket 
approval of the AutoPap 300 QC System. The device is an 
automated cervical cytology screening device intended for use in the 
quality control and rescreening of previously screened Papanicolaou 
(Pap) smear slides. The AutoPap 300 QC System is to be used 
only on conventionally prepared Pap smear slides that have been 
previously classified as within normal limits (WNL) and satisfactory 
for interpretation by a screening cytologist. The AutoPap 300 
QC System is not intended to replace the current laboratory slide 
review processes referred to as ``high risk rescreen.''
    On August 8, 1995, the Hematology and Pathology Devices Panel of 
the Medical Devices Advisory Committee, an FDA advisory committee, 
reviewed and recommended approval of the application. On September 29, 
1995, 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

[[Page 49781]]

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 October 23, 1996, 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: September 11, 1996.
Joseph A. Levitt,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-24364 Filed 9-18-96; 4:05 pm]
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