[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] ----------------------------------------------------------------------- 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HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 97D-0282] General Principles of Software Validation; Draft Guidance; Availability Agency: Food and Drug Administration, HHS.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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``General Principles of Software Validation.''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