[Federal Register Volume 62, Number 143 (Friday, July 25, 1997)]
[Notices]
[Pages 40099-40100]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-19611]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97D-0282]


General Principles of Software Validation; Draft Guidance; 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availability of a draft guidance entitled ``General Principles of 
Software Validation.'' This guidance is applicable to medical device 
software and to software used to design, develop, or manufacture 
medical devices. This guidance discusses how the general provisions of 
the Quality System Regulation apply to software and the agency's 
current approach to evaluating a software validation system.


[[Page 40100]]


DATES: Written comments by October 1, 1997.

ADDRESSES: Submit written requests for single copies of ``General 
Principles of Software Validation'' to the Division of Small 
Manufacturers Assistance (HFZ-220), Center for Devices and Radiological 
Health (CDRH), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-0806 (outside MD 1-800-638-2041). Send two 
self-addressed adhesive labels to assist that office in processing your 
requests. Submit written comments on ``General Principles of Software 
Validation'' to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. 
Requests and comments should be identified with the docket number found 
in brackets in the heading of this document. A copy of ``General 
Principles of Software Validation'' and received comments are available 
for public examination in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: E. Stewart Crumpler, Center for 
Devices and Radiological Health (HFZ-343), Food and Drug 
Administration, 2094 Gaither Rd., Rockville, MD 20850, 301-594-4659.

SUPPLEMENTARY INFORMATION: This guidance outlines general validation 
principles that FDA considers to be applicable to the validation of 
medical device software or the validation of software used to design, 
develop, or manufacture medical devices. This guidance discusses how 
the general provisions of the Quality System Regulation apply to 
software and the agency's current approach to evaluating a software 
validation system. For example, this guidance lists validation elements 
which are acceptable to FDA for the validation of software, however, it 
does not list all of the activities and tasks that must in all 
instances, be used to comply with the law. An alternative approach may 
be used if such approach satisfies applicable statutory and regulatory 
requirements.
    This guidance does not recommend any specific life cycle model or 
any specific validation technique or method, but does recommend that 
software validation activities be conducted throughout the entire 
software life cycle. For each software project, the responsible party 
should determine and justify the level of validation effort to be 
applied, and the specific combination of validation techniques to be 
used.
    The guidance in this document is based on generally recognized 
software validation processes and could therefore be applicable to any 
software. For FDA purposes, this guidance is applicable to any 
regulated medical device related software as defined by the Federal 
Food, Drug, and Cosmetic Act or by current FDA software and regulatory 
policy. It is not the intent of this document to determine or identify 
specifically which software is or is not regulated.
    This guidance represents the agency's current thinking on general 
principles of software validation. 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 requirements of the applicable statute, regulations, or both.
    Interested persons may, on or before October 1, 1997, submit to the 
Dockets Management Branch (address above) written comments on ``General 
Principles of Software Validation.'' 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. ``General Principles of Software Validation'' 
and received comments may be seen in the office above between 9 a.m. 
and 4 p.m., Monday through Friday. Persons with access to the Internet 
may obtain the new draft guidance via the World Wide Web (WWW) at 
``http://www.fda.gov/cdrh/comp/swareval.html''. The new draft guidance 
may also be obtained by calling the CDRH Facts-On-Demand system at 800-
899-0381 or 301-827-0111 from a fax machine with a touch-tone telephone 
attached or built in. At the first voice prompt press 1 to access DSMA 
Facts, at the second voice prompt press 2, and enter Shelf number 938 
followed by the pound sign (#). Then follow the remaining voice prompts 
to complete your request.

    Dated: July 15, 1997.
Elizabeth D. Jacobson,
Deputy Director for Science, Center for Devices and Radiological 
Health.
[FR Doc. 97-19611 Filed 7-24-97; 8:45 am]
BILLING CODE 4160-01-F