[Federal Register Volume 64, Number 164 (Wednesday, August 25, 1999)]
[Notices]
[Pages 46399-46400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21962]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2211]


Medical Devices; Draft Guidance for Industry on the Electro-
Optical Sensors for the In Vivo Detection of Cervical Cancer and its 
Precursors: Submission Guidance for an IDE/PMA; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance entitled ``Draft Guidance for Industry 
on the Electro-Optical Sensors for the In Vivo Detection of Cervical 
Cancer and its Precursors: Submission Guidance for an IDE/PMA.'' This 
draft guidance is intended to identify the elements for an 
investigational device exemption/premarket approval application (IDE/
PMA) for any electro-optical sensor in vivo device for the detection of 
cervical cancer or its precursors. This draft guidance covers electro-
optical devices applied to a woman's cervix in an in vivo setting that 
give a relatively instantaneous reading of test results for the 
purposes of detection of cervical cancer and its precursors. Many of 
these systems use complex signal discrimination algorithms and/or 
neural networks to differentiate abnormal from normal tissue. These new 
technologies, depending upon design and study results, may ultimately 
complement, as an adjunct, or replace the PAP smear, or it may serve to 
improve the results of colposcopy or biopsy. This draft guidance is 
neither final nor is it in effect at this time.

.DATES: Written comments concerning this draft guidance must be 
submitted by November 23, 1999.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the draft guidance. Submit written requests for 
single copies on a 3.5'' diskette of the draft guidance entitled 
``Draft Guidance for Industry on the Electro-Optical Sensors for the In 
Vivo Detection of Cervical Cancer and its Precursors: Submission 
Guidance for an IDE/PMA'' to the Division of Small Manufacturers 
Assistance (HFZ-220), Center for Devices and Radiological Health, Food 
and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send 
two self-addressed adhesive labels to assist that office in processing 
your request, or fax your request to 301-443-8818. Submit written 
comments concerning this draft guidance to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Colin M. Pollard, Center for Devices 
and Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1180.

 SUPPLEMENTARY INFORMATION:

 I. Background

    FDA is announcing the availability of a draft guidance entitled, 
``Draft Guidance for Industry on the Electro-Optical Sensors for the In 
Vivo Detection of Cervical Cancer and its Precursors: Submission 
Guidance for an IDE/PMA.'' This draft guidance is intended to identify 
the elements for an IDE and/or a PMA application for electro-optical 
sensors that are used in a clinical in vivo setting for the detection 
of cervical cancer or its precursors. This draft guidance is the result 
of several preliminary interactions between FDA and developers of this 
type of device, as well as input from experts at a meeting of FDA's 
advisory committee, the Obstetrics and Gynecology Devices Panel, on 
July 14 and 15, 1997. The draft guidance covers various types of hand-
held probes that employ electro-optical sensor technology to optically 
interrogate the cervix uteri for cancer and its precursors. Many of 
these systems use complex signal discrimination algorithms and/or 
neural networks to differentiate abnormal from normal tissue; and, 
generally, these sensors provide a relatively instantaneous riding of 
test results. The new technology covered by this guidance document, 
depending upon design and study results, may complement, as an adjunct, 
or replace the PAP smear, or it may serve to improve the results of 
colposcopy or biopsy. These in vivo detection devices apply several 
different optical phenomena, including autofluorescence and Raman 
spectroscopy. Some may include bioelectrical phenomena.
    This draft guidance document represents the agency's current 
thinking on the appropriate content of IDE/PMA applications for in vivo 
devices for the detection of cervical cancer and its precursors. It 
does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach may be used 
if such approach satisfies the applicable statute, regulations, or 
both.
    The agency has adopted good guidance practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This draft guidance document is issued as a level 1 guidance 
consistent with GGP's.

 II. Electronic Access

    In order to receive ``Draft Guidance for Industry on the Electro-
Optical Sensors for the In Vivo Detection of Cervical Cancer and its 
Precursors: Submission Guidance for an IDE/PMA'' via your fax machine, 
call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 301-827-
0111 from a touch-tone telephone. At the first voice prompt press 1 to 
access DSMA Facts, at second voice prompt press 2, and then enter the 
document number (266) followed by the pound sign (#). Then follow the 
remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so using the World Wide Web (WWW). CDRH maintains an entry on 
the WWW for easy access to information including text, graphics, and 
files that downloaded to a personal computer with access to the WWW. 
Updated on a regular basis, the CDRH home page includes the ``Draft 
Guidance for Industry on the Electro-Optical Sensors for the In Vivo 
Detection of Cervical Cancer and its Precursors: Submission Guidance 
for an IDE/PMA,'' device safety alerts, Federal Register reprints, 
information on premarket submissions (including lists of approved 
applications and manufacturers' addresses), small manufacturers' 
assistance, information on video conferencing and electronic 
submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at ``http://
www.fda.gov/cdrh''. The ``Draft Guidance for Industry on the Electro-
Optical Sensors for the In Vivo Detection of Cervical Cancer and its 
Precursors: Submission Guidance for an IDE/PMA'' will be available at 
``http://www.fda.gov/scripts/cdrh/ctdocs/cfggp/results.cfm''.

 III. Comments

     Interested persons may, on or before November 23, 1999, submit to 
the Dockets Management Branch (address

[[Page 46400]]

above) written comments regarding this draft guidance. Two copies of 
any comments are to be submitted, except individuals may submit one 
copy. Comments should be identified with the docket number found in 
brackets in the heading of this document. A copy of the draft guidance 
and received comments are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: July 28, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-21962 Filed 8-24-99; 8:45 am]
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