[Federal Register Volume 62, Number 8 (Monday, January 13, 1997)]
[Notices]
[Pages 1767-1768]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-715]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 96D-0300]


Reviewer Guidance for a Premarket Notification Submission for 
Blood Establishment Computer 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 guidance document entitled ``Reviewer Guidance for a 
Premarket Notification Submission for Blood Establishment Computer 
Software.'' The guidance document applies to blood establishment 
software products intended for use in the manufacture of blood and 
blood components or for the maintenance of data that blood 
establishment personnel use in making decisions regarding the 
suitability of donors and the release of blood or blood components for 
transfusion or further manufacture. The guidance presents an overview 
of the type of information, including methods and procedures, that 
FDA's reviewers should expect to be included in 510(k) submissions for 
such devices and describes the approach FDA's reviewers should take in 
reviewing premarket submissions for blood establishment computer 
software.

DATES: Written comments may be submitted at any time, however, to 
ensure comments are considered for the next revision they should be 
submitted by April 14, 1997.

ADDRESSES: Submit written comments and information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857. Submit written requests 
for single copies of the guidance entitled ``Reviewer Guidance for a 
Premarket Notification Submission for Blood Establishment Computer 
Software'' to the Office of Communication, Training, and Manufacturers 
Assistance (HFM-40), Center for Biologics Evaluation and Research, Food 
and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. 
Send one self-addressed adhesive label to assist that office in 
processing your requests.
    The document may also be obtained by calling the CBER Voice 
Information System at 1-800-835-4709 or 301-827-1800, or FAX at 1-800-
CBER-FAX, or 301-827-3844.
    Persons with access to the INTERNET may obtain the document using 
the World Wide Web (WWW), or bounce-back e-mail. For WWW access, 
connect to CBER at ``http.fda.gov/cber/cberftp.html''. To receive the 
document by bounce-back e-mail, send a message to 
``[email protected]''.
FOR FURTHER INFORMATION CONTACT: Nancy J. Jensen, Office of Blood 
Research and Review/Division of Blood Applications, Center for 
Biologics Evaluation and Research (HFM-385), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
3524.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a

[[Page 1768]]

``Reviewer Guidance for a Premarket Notification Submission for Blood 
Establishment Computer Software.'' A premarket notification (510(k)) is 
an application submitted to FDA under section 510(k) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(k)), to 
demonstrate that the medical device to be marketed is substantially 
equivalent to a legally marketed device that was or is currently on the 
U.S. market.
    In a March 31, 1994, letter sent to manufacturers of blood 
establishment computer software, FDA stated that software products used 
in the manufacture or maintenance of data for blood and blood 
components are devices under section 201(h) of the act (21 U.S.C. 
321(h)) because these products aid in the prevention of disease by 
identifying unsuitable donors and by preventing the release of 
unsuitable blood and blood components for transfusion or for further 
manufacturing use. The original date for submissions was March 31, 
1995, but after careful evaluation of the needs expressed by the 
software manufacturers and the impact of the initiative on blood 
establishments, FDA concluded that a 1-year extension to March 31, 
1996, was warranted. FDA notified known manufacturers of blood 
establishment computer software of the extension, by letter, the text 
of which was published in the Federal Register of October 3, 1995 (60 
FR 51802). The reviewer guidance was presented and discussed at the 
Blood Products Advisory Committee meeting held on June 20, 1996.
    The content and format required for a 510(k) submission may be 
found in 21 CFR part 807. FDA intends that the guidance document will 
be used as a supplement to the ``Reviewer Guidance for Computer 
Controlled Medical Devices Undergoing 510(k) Review,'' issued by the 
Center for Devices and Radiological Health on August 29, 1991. The 
reviewer guidance announced in this notice contains a description of 
the content and format that a reviewer should expect in a 510(k) 
submission for blood establishment computer software.
    As with other guidance documents, FDA does not intend this document 
to be all-inclusive. Moreover, not all information may be applicable to 
all situations. The reviewer guidance document is intended to provide 
information and does not set forth requirements. Although this guidance 
document does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public, it does represent the 
agency's current thinking on the review of premarket notification 
submissions for blood establishment computer software.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the reviewer guidance document. Two 
copies of any comments are to be submitted, except that individuals may 
submit one copy. Comments and information are to be identified with the 
docket number found in brackets in the heading of this document. The 
guidance document and received comments are available for public 
examination in the office above between 9 a.m. and 4 p.m., Monday 
through Friday.
    FDA anticipates revising the reviewer guidance document 
periodically, in response to comments received or to reflect 
advancements in blood establishment computer software.

    Dated: December 31, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-715 Filed 1-10-97; 8:45 am]
BILLING CODE 4160-01-F