[Federal Register Volume 63, Number 158 (Monday, August 17, 1998)]
[Notices]
[Pages 43951-43952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21996]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0565]
Off-the-Shelf Software Use in Medical Devices; Draft Guidance;
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availability of a draft guidance document entitled ``Off-the-Shelf
Software Use in Medical Devices.'' This draft guidance document is not
final or in effect at this time. The purpose of the draft guidance
document is to describe the information that should be provided in a
medical device application involving Off-the-Shelf (OTS) software.
While the draft guidance document is not intended for compliance with
Quality System requirements, many of the principles outlined may be
helpful to device manufacturers in establishing design controls and
validation plans for use of off-the-shelf software in their devices.
DATES: Submit written comments by November 16, 1998. After the close of
the comment period, written comments may be submitted at any time to
Daniel A. Spyker (address below).
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit written requests for single copies on a
3.5'' diskette of the draft guidance document entitled ``Off-the-Shelf
Software Use in Medical Devices'' 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. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Daniel A. Spyker, Center for Devices
and Radiological Health (HFZ-450), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-443-8320.
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance document was developed to address the many
questions asked by medical device manufacturers regarding what they
need to provide to FDA when they use OTS software. The response to
these questions depends on the medical device in question and the
impact on patient safety when the OTS software fails. Thus, the answer
to the question ``What do I need to do or document?'' will be based on
the hazard analysis that is an integral part of designing a medical
device. The detail of documentation to be provided to FDA and the level
of life cycle control necessary for the medical device manufacturer
increase as the hazard to the patient from software failure increases.
This draft guidance document lays out in broad terms how the
medical device manufacturer should determine what is necessary to do
and to document for submission to the agency. A ``BASIC'' set of need-
to-do items is proposed for OTS software, and a detailed discussion is
provided on additional (``SPECIAL'') needs and responsibilities of the
manufacturer when hazards from OTS software failure become more
significant.
II. Significance of Guidance
This draft guidance document represents the agency's current
thinking on use of OTS software in medical devices. 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 2 guidance
document
[[Page 43952]]
consistent with GGP's. This draft guidance document was first made
available on the internet on June 20, 1997. FDA now believes that it
would be useful to make the document more widely available for comment.
III. Electronic Access
In order to receive the draft guidance document ``Off-the-Shelf
Software Use In Medical Devices,'' via your fax machine, call the CDRH
Facts-On-Demand (FOD) 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
(585) followed by the pound sign (#). Then follow the remaining voice
prompts to complete your request.
Persons interested in obtaining a copy of the 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
may be downloaded to a personal computer with access to the Web.
Updated on a regular basis, the CDRH home page includes ``Off-the-Shelf
Software Use In Medical Devices'' 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''.
IV. Comments
Interested persons may, on or before November 16, 1998, submit to
the Dockets Management Branch (address above) written comments
regarding this draft guidance. Two copies of any comments are to be
submitted, except that individuals may submit one copy. Comments are to
be identified with the docket number found in brackets in the heading
of this document. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
After November 16, 1998, written comments regarding this draft
guidance document may be submitted at any time to the contact person
(address above).
Dated: August 4, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-21996 Filed 8-14-98; 8:45 am]
BILLING CODE 4160-01-F
