[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]
BILLING CODE 4160-01-F
