[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]
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