[Federal Register Volume 60, Number 191 (Tuesday, October 3, 1995)]
[Notices]
[Pages 51802-51803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24534]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Letter to Manufacturers of Blood Establishment Computer Software 
Products; Extension of Time Period for Premarket Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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Summary: The Food and Drug Administration (FDA) has revised the 
schedule for compliance with the premarket submission requirements for 
manufacturers of blood establishment computer software. After careful 
evaluation of the concerns expressed by the manufacturers, the impact 
of the regulatory initiative on blood establishments, and the public 
health significance of assuring the safety and quality of this 
software, FDA concluded that a 1-year extension of the time period for 
premarket submissions was warranted. In this notice, the agency is 
publishing the text of the February 10, 1995, letter sent to the 
manufacturers announcing a deadline of March 31, 1996, for premarket 
submissions.

ADDRESSES: To obtain a copy of the device registration package and 
device listing, write to the Center for Devices and Radiological 
Health, Division of Small Manufacturers Assistance (HFZ-220), 5600 
Fishers Lane, Rockville, MD 20857. For guidance concerning premarket 
submissions, write to the Center for Biologics Evaluation and Research, 
Division of Blood Applications (HFM-370), 1401 Rockville Pike, 
Rockville, MD 20852-1448.

FOR FURTHER INFORMATION CONTACT: Timothy W. Beth, Center for Biologics 
Evaluation and Research (HFM-635), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.

SUPPLEMENTARY INFORMATION: In a March 31, 1994, letter sent to 
manufacturers of blood establishment computer software, FDA stated that 
certain 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 March 31, 1994, letter stated that 
manufacturers would be required to make premarket submissions to CBER 
for each of their devices no later than March 31, 1995. The March 31, 
1994, letter was published in the Federal Register of August 31, 1994 
(59 FR 44991).
    Numerous responses from organizations representing both software 
manufacturers and blood establishments expressed concerns about the 
requirements for premarket clearances or approval and many requested 
additional time to comply with such requirements. After careful 
evaluation of the needs expressed by the software manufacturers and the 
impact of this regulatory initiative on blood establishments, FDA 
concluded that a 1-year extension to the deadline was warranted. 
Therefore, by letter dated February 10, 1995, FDA notified known 
manufacturers of blood establishment computer software products that 
premarket submissions should be submitted to CBER no later than March 
31, 1996. The complete text of the February 10, 1995, letter follows:

February 10, 1995
To: Blood Establishment Computer Software Manufacturers
Dear Sir/Madam:
    The purpose of this letter is to notify you of the revised 
schedule for compliance with the various provisions of the Federal 
Food, Drug, and Cosmetic Act for premarket submissions for blood 
establishment computer software products regulated as medical 
devices. The schedule has been developed after careful evaluation of 
the concerns expressed by the software manufacturers, the impact of 
the regulatory initiative on blood establishments, and the public 
health significance of assuring the safety and quality of this 
software.
    In a letter dated March 31, 1994, the FDA stated that the agency 
considers software

[[Page 51803]]

products intended for use in the manufacture of blood and blood 
components or for the maintenance of data that personnel use in 
making decisions regarding the suitability of donors and the release 
of blood or blood components for transfusion of further manufacture 
are devices under section 201(h) of the Federal Food, Drug, and 
Cosmetic Act (the Act) [21 U.S.C. Sec. 321(h)]. This initiative was 
also described in a Federal Register (FR) notice dated August 31, 
1994 (59 44991) [copy enclosed].
    As a medical device manufacturer, you are currently required 
under the Act to register your establishment and list your devices. 
In addition, your manufacturing operations are required to be in 
compliance with CGMP for devices, and you must report adverse events 
and other problems as required by FDA's Medical Device Reporting 
(MDR) regulations. FDA's device registration and listing regulations 
appear at Title 21, Code of Federal Regulations (CFR), Part 807; 
CGMP regulations for devices appear at 21 CFR, Part 820; and the MDR 
regulations appear at 21 CFR, Part 803. These and other specific 
points relating to establishment inspections noted in the March 31, 
1994, letter and the August 31, 1994, Federal Register notice remain 
unchanged.
    In these documents, FDA stated that manufacturers of blood 
establishment computer software would be required to submit to the 
Center for Biologics Evaluation and Research (CBER) a premarket 
notification or application for premarket approval for each of their 
devices no later than March 31, 1995. The agency received numerous 
responses from organizations representing both software 
manufacturers and blood establishments. The principal concern 
expressed in these responses related to the requirements for 
premarket clearances or approval for blood establishment computer 
software products. The concerns included, but were not limited to, 
the difficulty of expeditious compliance with the requirement for 
premarket clearance or approval, the need for additional, detailed 
guidance to be used in the preparation of premarket submissions for 
these specific software products, and additional time needed to 
remove software from use by blood establishments in situations where 
a software manufacturer does not intend to seek premarket clearance 
or approval for the particular product.
    After careful evaluation of the needs expressed by the software 
manufacturers and the impact of this regulatory initiative on blood 
establishments, the FDA has concluded that a one year extension of 
the March 31, 1995, deadline is warranted. Therefore, premarket 
submissions should be submitted to CBER no later than March 31, 
1996. The extension period for premarket submissions does not, 
however, affect other responsibilities of the computer software 
manufacturers and distributors who are subject to the device 
provisions of the Act and implementing regulations as previously 
stated.
    To effectively implement this important and complex regulatory 
program, the agency intends to work with industry to clarify the 
expectations concerning premarket submissions through issuance of 
guidance. We also plan to have a continuing dialogue with affected 
establishments and industry organizations.
    Also, within this extension period, it is the FDA's expectation 
that vendors and blood establishments will cooperatively conduct all 
transitions from software products for which premarket clearance or 
approval will not be sought to software products for which premarket 
clearance or approval is being actively pursued. These transitions 
should also be conducted in an orderly and effective manner so that 
they have minimal impact on the blood establishment's operations as 
they relate to the identity, safety, purity, and quality of blood 
products. These transitions should also be completed by March 31, 
1996.
    If you do not intend to make a premarket submission as outlined 
in the August 31, 1994, Federal Register notice, this information 
should be promptly sent to: Center for Biologics Evaluation and 
Research (CBER), Division of Blood Applications (HFM-370), 1401 
Rockville Pike, Rockville, MD 20852-1448. The information should 
include your intent to remove software from the market and identify 
the steps to be taken and the support to be provided during the time 
needed for users to efficiently transition to other products or 
software manufacturers by March 31, 1996.
    If you intend to make a premarket submission and have not done 
so by September 30, 1995, we request that you notify CBER by letter 
of the specific progress made by that point in time, the work 
remaining to be completed, and the anticipated date of filing each 
applicable premarket submission if not completed and submitted by 
September 30, 1995.
    If you have questions concerning: (1) the preparation of the 
establishment registration and device listing notification, contact 
Center for Devices and Radiological Health, Division of Small 
Manufacturers Assistance (HFZ-220), at 301-443-6597, or (2) guidance 
for premarket submissions, contact Center for Biologics Evaluation 
and Research, Division of Blood Applications (HFM-370), at 301-594-
2012. Please note that information regarding the content and format 
for premarket notification submission can be found at 21 CFR, Part 
807, Subpart E.

    Dated: September 26, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-24534 Filed 9-28-95; 11:22 am]
BILLING CODE 4160-01-F