[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Off-the-Shelf Software Use in Medical Devices; Draft Guidance; 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availability of a draft guidance document entitled ``Off-the-Shelf 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 This draft guidance document is not 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 The purpose of the draft guidance 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While the draft guidance document is not intended for compliance with 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3.5'' diskette of the draft guidance document entitled ``Off-the-Shelf 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to the draft guidance document.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    This draft guidance document was developed to address the many 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]
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