[Federal Register Volume 60, Number 239 (Wednesday, December 13, 1995)]
[Notices]
[Pages 64066-64067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-30333]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0363]


Medical Devices; Review of Computer-Aided Diagnostic Software 
Devices; Notice of Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
workshop to discuss the appropriate approach to the review of premarket 
submissions for computer-aided diagnostic (CADx) medical devices. 
Because there is increasing interest in and development of CADx medical 
devices, the agency is holding this workshop to obtain public comments 
and suggestions that may help FDA develop device description and 
assessment methodologies for reviewer guidance for premarket 
submissions for these CADx medical devices.


[[Page 64067]]

DATES: The workshop will be held on January 26, 1996, from 9 a.m. to 
4:30 p.m. Participants and other persons who want to be heard must be 
present by 9 a.m. Submit written notices of participation on or before 
January 15, 1996.

ADDRESSES: The workshop will be held at the Parklawn Bldg., conference 
room D, 5600 Fishers Lane, Rockville, MD. Written comments, identified 
with the docket number found in brackets in the heading of this 
document, regarding reviewer guidance for CADx devices may be submitted 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Mary P. Anderson, Center for Devices 
and Radiological Health (HFZ-142), 12720 Twinbrook Pkwy., Rockville, MD 
20852, 301-443-5020 ext. 40, FAX 301-443-9101.

    Contact Mary Anderson (address above) for a registration form for 
the workshop. There is no registration fee but advance registration is 
required. Interested persons are encouraged to register early because 
space is limited. Persons with disabilities who require special 
assistance to attend or participate in the workshop can be accommodated 
if advance notification is provided. If you have a disability that 
affects your attendance at, or participation in, this meeting, please 
contact Mary Anderson (address and telephone number above), in writing 
and identify your needs. The availability of appropriate accommodations 
cannot be assured unless prior written notification is provided.
SUPPLEMENTARY INFORMATION:

I. Background

    FDA anticipates receiving increasing numbers of premarket 
submissions for CADx medical devices. Some of these devices are 
accessories that analyze data produced by diagnostic medical devices, 
such as digital radiography systems, and highlight possible findings 
which assist the device user in interpreting such data. An example of 
such a device is an automated Pap smear reader. In order to develop 
reviewer guidance for appropriate device description and assessment 
methodologies in premarket submissions for these devices, FDA has 
established a computer-aided diagnostic device working group. This 
working group is in the process of evaluating the agency's approach to 
review of premarket submissions for these medical devices.

II. Purpose and Tentative Agenda of the Workshop

    The purpose of the public workshop is to obtain suggestions that 
will help FDA develop reviewer guidance for device description and 
assessment methodologies in premarket submissions for CADx medical 
devices.
     Presiding over the workshop will be: David G. Brown, Chief 
Scientist, and Mary P. Anderson, Chief of the Medical Imaging and 
Computer Applications Branch, Division of Electronics and Computer 
Systems, Office of Science and Technology, Center for Devices and 
Radiological Health, FDA. They will be assisted by other FDA officials.
    FDA will open the workshop with a summary of the present status of 
FDA review of these devices. This presentation will provide information 
on the impetus, objectives, and scope of the FDA's activities in this 
area. Following FDA's presentation, a specific period of time will be 
provided for participants to make presentations. Interested persons who 
wish to participate in the public workshop may, on or before January 
15, 1996, submit a written notice of participation to the Dockets 
Management Branch (address above) identified with the docket number 
found in brackets in the heading of this document, including name, 
address, telephone number, business affiliation, a brief summary of the 
presentation, and an estimate of the amount of the time required for 
comments.
     FDA requests that individuals or groups having similar interests 
consolidate their comments and present them through a single 
representative. FDA may require joint presentations by persons with 
common interests. A schedule of the allotted times will be available at 
the workshop. Each participant will be notified before the workshop of 
the approximate time of their presentation. The schedule will be placed 
on file in the Dockets Management Branch under the docket number found 
in brackets in the heading of this document. The workshop will also 
include an opportunity for interested persons who did not submit a 
notice of participation to make brief statements or comments, if time 
permits. The workshop will then proceed to a panel discussion of 
specific issues to be considered in developing FDA's approach to the 
review of premarket submissions for CADx medical devices. The workshop 
is informal, and the rules of evidence will not apply. No participant 
may interrupt the presentation of another participant.

    Dated: November 28, 1995.
D. B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 95-30333 Filed 12-12-95; 8:45 am]
BILLING CODE 4160-01-F