[Federal Register Volume 61, Number 239 (Wednesday, December 11, 1996)]
[Notices]
[Pages 65228-65229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31422]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96M-0472]


Neuromedical Systems, Inc.; Premarket Approval of the 
PAPNET Testing 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 Neuromedical Systems, Inc., Suffern, NY, 
for premarket approval, under the Federal Food, Drug, and Cosmetic Act 
(the act), of the PAPNET Testing 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 November 8, 1995, of the approval of the 
application.

DATES: Petitions for administrative review by January 10, 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 September 21, 1994, Neuromedical Systems, 
Inc., Suffern, NY 10901-4164, submitted to CDRH an application for 
premarket approval of the PAPNET Testing System. The device 
is a semi-automated test indicated to aid in the rescreening of 
cervical Papanicolaou (Pap) smears previously reported as negative. The 
PAPNET Testing System is intended to detect evidence of 
cervical epithelial abnormalities including the following categories of 
the Bethesda System for classification of cervical cytology results: 
(1) Primary squamous cell carcinoma of the cervix and its possible 
precursor lesions, i.e., low grade squamous intra epithelial lesions 
(LGSIL), high grade intra epithelial (HGSIL), and atypical squamous 
cells of undetermined significance (ASCUS); and (2) primary 
endocervical adenocarcinoma and its possible precursor lesion, atypical 
glandular cells of undetermined significance (AGUS). The 
PAPNET testing is intended as an adjunct to all standard 
laboratory quality control and mandated re-screening procedures.
    On August 7, 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 November 8, 
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 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

[[Page 65229]]

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 January 10, 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. 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 24, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-31422 Filed 12-10-96; 8:45 am]
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