[Federal Register Volume 61, Number 136 (Monday, July 15, 1996)]
[Notices]
[Pages 36886-36887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17880]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 86D-0380]


Medical Devices; Medical 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) and the National 
Library of Medicine (NLM) are announcing a public workshop to discuss 
definitions of medical software devices, criteria for defining risk 
categories, software quality audits and premarket notification, 
commercial distribution of software, and the options available for 
regulating medical software devices. FDA has noted some confusion among 
manufacturers regarding which requirements apply to medical software 
devices and accessories. This workshop will help to clarify the 
requirements, and provide FDA with information to better assess the 
risks to public health associated with different types of medical 
software devices.

DATES: The workshop will be held on September 3 and 4, 1996, from 9:30 
a.m. to 4:30 p.m. Participants and other persons who want to present 
data or information must be present by 9 a.m. Written notices of 
participation must be submitted on or before August 5, 1996.

ADDRESSES: The workshop will be held at the National Institutes of 
Health, Natcher Conference Center, 45 Center Dr., Bethesda, MD 20892. 
Written comments, identified with the docket number found in brackets 
in the heading of this document, regarding the subjects being discussed 
at the workshop may be submitted to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. A more detailed listing of the workshop topics, 
issues, background information, as well as registration forms, can be 
obtained after August 1, 1996, through the Center for Devices and 
Radiological Health (CDRH) Facts-On-Demand system. To receive the 
public workshop on medical software devices documents to your FAX 
machine, call the CDRH Facts-On-Demand 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, 1072, followed by the pound sign (#). Then follow 
the remaining voice prompts to complete your request. The information 
will be sent by FAX. All workshop-related information can also be 
obtained by using the World Wide Web. FDA's home page address may be 
accessed at http://www.fda.gov.
FOR FURTHER INFORMATION CONTACT: Charles S. Furfine, Center for Devices 
and Radiological Health (HFZ-143), 12720 Twinbrook Pkwy., Rockville, MD 
20852, 301-443-2536, ext. 16; FAX 301-443-9101; or EMail 
[email protected].
    Registration forms should be sent to Charles Furfine (address 
above). There is no registration fee but advance registration is 
required. Interested persons are encouraged to register early because 
space is limited. If you have a disability that affects your attendance 
at, or participation in, this meeting, please contact Charles S. 
Furfine (address above) in writing and identify your needs. The 
availability of appropriate accommodations cannot be assured unless 
prior written notification is provided.
SUPPLEMENTAL INFORMATION: 

I. Background

    On September 25, 1987 (52 FR 36104), FDA published a notice of 
availability of a ``Draft Policy Guidance for Regulation of Computer 
Products,'' which the agency was making available for comment. The 
guidance was intended to provide software developers and manufacturers 
of medical devices with guidance about which software products were 
regulated as medical devices and which might be exempt from particular 
regulatory controls, such as premarket notification. A 1989 draft of 
the FDA software policy reiterated the basic statements of the 1987 
draft, but also addressed specific issues related to blood-bank 
software products. The 1989 draft also addressed the issue of which 
medical software devices should be exempt from general controls, 
including the current good manufacturing practice regulations. The 
agency stated in the 1989 draft that medical software devices 
(unclassified medical software devices that are not components, parts, 
or accessories to classified devices) would not be subject to active 
regulatory oversight if they ``are intended to involve competent human 
intervention before any impact on human health occurs (e.g., where 
clinical judgment and experience can be used to check and interpret a 
system's output) * * *.''
    Since 1989, FDA has gained experience in applying the criterion of

[[Page 36887]]

competent human intervention on a case-by-case basis to medical 
software devices and has noted two problems that arise. First, some 
manufacturers have brought to market medical software devices that are 
actually accessories to classified medical devices without a premarket 
submission, most likely because of confusion over which devices were 
meant to be covered by the draft policy. Components, parts, or 
accessories to classified devices are regulated according to the class 
of the parent device and are not covered by the draft policy. Second, 
the increasing complexity and sophistication of current software 
devices makes it increasingly difficult to decide when healthcare 
practitioners can, in fact, comprehend the functions performed by the 
software sufficiently to know when significant errors have occurred.
    FDA is, therefore, reassessing its position regarding the 
regulation of medical software devices. Further, it is important that 
any exemption from regulatory oversight continue to be based upon an 
assessment of the risk to human health, as provided by law. 
Additionally, FDA believes that increased application of proper 
engineering practices provides an opportunity to develop preproduction 
controls for the majority of medical software devices which may obviate 
the need for premarket submissions for such medical software devices in 
some cases.

II. Purpose and Tentative Agenda of the Workshop

    -The purpose of the workshop is to obtain information on subjects 
such as: (1) Definitions that could be used in the classification of 
medical software devices; (2) criteria that could be used to define 
risk categories; (3) the scope and content of a proposed software 
quality audit that might be used in lieu of premarket notification for 
certain medical software devices; (4) factors related to the unique 
characteristics of the distribution of software that the agency could 
consider in determining whether a particular medical software product 
is intended by the manufacturer or sponsor for commercial distribution; 
and (5) potential scenarios and regulatory hurdles to implementing a 
risk-based classification process. This will provide FDA with 
information to better assess the risks to public health associated with 
different types of medical software devices.
    Presiding over the workshop will be: Harvey Rudolph, Acting Deputy 
Director, Office of Science and Technology, Center for Devices and 
Radiological Health, and Harold Schoolman, Deputy Director for 
Education and Research, NLM. They will be assisted by other FDA and NLM 
officials.
    Opening remarks will be made by representatives of the sponsoring 
institutions, FDA and NLM, identifying the respective agency's 
interests in medical software devices. Following these presentations, 
FDA will make a presentation outlining its responsibilities for 
regulating medical software devices and for identifying specific areas 
where information from the public could be most useful. Following FDA's 
presentation, a specific period of time will be provided for other 
participants to make presentations. There will be break-out sessions 
following these presentations where discussion can take place on 
specific topics, such as those noted above.
    Interested persons who wish to present prepared comments at the 
plenary session to the public workshop may, on or before August 5, 
1996, submit to the Dockets Management Branch (address above) a written 
notice of participation identified with the docket number found in 
brackets in the heading of this document, including name, address, 
telephone number, business affiliation, and a brief summary of the 
presentation. The limited time available will allow 10 minutes or less 
for each presentation.
    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 his or her presentation. The schedule will be 
placed on file in the Dockets Management Branch (address above) 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 is informal; however, no participant may interrupt the 
presentation of another participant.

    Dated: July 9, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-17880 Filed 7-12-96; 8:45 am]
BILLING CODE 4160-01-F