[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