[Federal Register Volume 61, Number 248 (Tuesday, December 24, 1996)]
[Notices]
[Pages 67837-67838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-32683]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96D-0368]


Guidance for the Content of Premarket Submissions for Medical 
Devices Containing Software; 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availability of a draft guidance entitled ``ODE Guidance for the 
Content of Premarket Submissions for Medical Devices Containing 
Software.'' The draft guidance is not final nor is it in effect at this 
time. This guidance is available for comment and will eventually 
replace the ``Reviewer Guidance for Computer Controlled Medical Devices 
Undergoing 510(k) Review'' that was issued in 1991 (the 1991 draft 
guidance). This new draft guidance discusses the key elements reviewers 
look for in premarket medical device software submissions and provides 
a common baseline from which both manufacturers and scientific 
reviewers can operate. The new draft guidance is intended to provide 
applicants specific additional directions regarding information and 
data that should be submitted to FDA in a 510(k) submission for medical 
device software.

DATES: Submit written comments by January 23, 1997.
ADDRESSES: Submit written requests for single copies of the draft 
guidance entitled ``ODE Guidance for the Content of Premarket 
Submissions for Medical Devices Containing Software'' 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. Persons with access to the Internet may 
obtain the new draft guidance via the World Wide Web at http://
www.fda.gov/cdrh/ode/dtswguid.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 The new draft guidance may also be 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__ 616 followed by the 
pound sign (#). Then follow the remaining voice prompts to complete 
your request. Submit written comments on ``ODE Guidance for the Content 
of Premarket Submissions for Medical Devices Containing Software'' 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 ``ODE Guidance for the 
Content of Premarket Submissions for Medical Devices Containing 
Software'' 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: Joanna H. Weitershausen, Center for 
Devices and Radiological Health (HFZ-450), Food and Drug 
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-
8609.

SUPPLEMENTARY INFORMATION:  The final version of this guidance will 
provide guidance concerning regulatory review of premarket medical 
device software submissions under section 510(k) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360(k)) (the act). The new draft 
guidance has been developed to clarify the existing guidance. Through 
using the 1991 draft guidance for the last 4 years, FDA has gained 
experience in applying guidance to 510(k) submissions for medical 
devices using software. Comments were received from both manufacturers 
and scientific reviewers and have been incorporated into the new draft 
guidance. By clarifying the guidance, the agency hopes to receive a 
larger percentage of complete premarket submissions upon submittal. 
This will avoid the need for additional information requests which are 
time consuming for both FDA and manufacturers. In addition, the 
guidance has been updated to be consistent with emerging international 
consensus standards such as IEC 601-1-4 and ISO 9000.
    The process for determining the level of concern (i.e., the 
severity of risk that a device could permit or inflict on a patient or 
operator as a result of latent failures, design flaws, or using the 
device) for medical device software, as discussed in the 1991 draft 
guidance, caused confusion for both FDA scientific reviewers and the 
medical device industry. Section 3 of the new draft guidance updates 
this process. However, the agency realizes that other

[[Page 67838]]

options exist; these options are identified in Attachment 2 of a letter 
included with the new draft guidance. Comments on the new draft 
guidance should indicate and explain the option(s) preferred.
    On May 17, 1995, the new draft guidance was presented at the 
Indiana Medical Device Manufacturers Council seminar. This seminar 
focused on the development of medical device software in a regulated 
environment. The new draft guidance was again presented on September 
21, 1995, at the 19th Annual Regulatory Affairs Professional Society 
Exhibition and Conference.
    The intent of the final version of this guidance will be to provide 
applicants specific additional directions regarding information and 
data that should be submitted to FDA in a 510(k) submission for medical 
device software.
    This guidance, when finalized, will apply to all software, which 
includes embedded software, operator assisted software, and software 
accessories to medical devices. The new draft guidance excludes pure 
hospital information systems and manufacturing process control 
software.
    Although this guidance does not create or confer any rights on or 
for any person and does not operate to bind the agency in any way, it 
does represent FDA's current thinking on the content of premarket 
submissions for medical devices containing software.
    Interested persons may, on or before January 23, 1997, submit to 
the Dockets Management Branch (address above) written comments on the 
``ODE Guidance for the Content of Premarket Submission for Medical 
Devices Containing Software.'' Comments should: (1) Refer to specific 
line numbers, sections, and page numbers in the document; (2) discuss 
the issue; and (3) propose a recommended change. 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. The new draft guidance and 
received comments may be seen in the Dockets Management Branch between 
9 a.m. and 4 p.m., Monday through Friday. Received comments will be 
considered in determining whether further revisions to the draft 
guidance are warranted.

    Dated: December 13, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-32683 Filed 12-23-96; 8:45 am]
BILLING CODE 4160-01-F