[Federal Register Volume 59, Number 168 (Wednesday, August 31, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-21389]


[[Page Unknown]]

[Federal Register: August 31, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

 

Letter to Manufacturers of Blood Establishment Computer Software 
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a letter 
sent to known manufacturers of blood establishment computer software 
products. In the letter, FDA advised these manufacturers that it 
considers these computer software products to be devices under the 
Federal Food, Drug, and Cosmetic Act (the act) because these products 
aid in the prevention of disease by identifying unsuitable donors and 
preventing the release of unsuitable blood and blood components for 
transfusion or for further manufacturing use. The letter, accompanied 
by a registration package and device listing, was intended to notify 
manufacturers of the requirements of the act, to facilitate 
registration of these manufacturers as medical device manufacturers, 
and to further ensure the safety of the blood supply.

FOR FURTHER INFORMATION CONTACT: Timothy W. Beth, Center for Biologics 
Evaluation and Research, Office of Compliance, Regulations Branch (HFM-
635), 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-3074.

ADDRESSES: To obtain a copy of the medical 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.

SUPPLEMENTARY INFORMATION: The Food and Drug Administration (FDA) is 
publishing a March 31, 1994, letter sent to known manufacturers of 
blood establishment computer software products. The letter was sent by 
the Center for Biologics Evaluation and Research (CBER) to notify these 
manufacturers that their products meet the definition of a device under 
section 201(h) of the act (21 U.S.C. 321(h)) and to facilitate 
registration of these manufacturers with FDA as device manufacturers. 
The regulatory approach outlined in the March 31, 1994, letter is part 
of the effort by FDA to further ensure the safety of the blood supply. 
This notice is being issued to ensure that all interested persons are 
aware of the requirements of the act and have access to the information 
in the letter.
    In order to facilitate registration with FDA as a device 
manufacturer, the March 31, 1994, letter was accompanied by a 
registration package. To obtain a copy of the registration package and 
device listing forms and instructions, write to the Center for Devices 
and Radiological Health (address above). Manufacturers of such software 
are required to register their establishments and list their devices. 
Each manufacturer is also required to submit a premarket notification 
or application for premarket approval to CBER for each device unless 
the manufacturer can demonstrate that the manufacturer commercially 
distributed the device in interstate commerce prior to May 28, 1976 
(the date of enactment of the Medical Device Amendments of 1976), and 
has continued to distribute the device without any significant changes 
to the device. Guidance on how to prepare a premarket submission as 
well as device listing information will be sent to each manufacturer 
after they have registered. The letter stated that manufacturers should 
submit premarket submissions to CBER no later than March 31, 1995.
    Additionally, the letter stated that FDA intends to inspect blood 
establishment software vendors in the interim period and to focus 
primarily on assessing compliance with current good manufacturing 
practice (CGMP) regulations for devices (21 CFR part 820). FDA also 
will review and assess procedures for investigating reports of product 
problems and defects, implementing and evaluating corrective actions, 
and for notifying FDA and customers of the corrective actions. The 
complete text of the letter follows:
March 31, 1994
To: Blood Establishment Computer Software Manufacturers
Dear Sir/Madam:
    The purpose of this letter is to advise you that the Food and 
Drug Administration (FDA) considers software 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 or further manufacture to be devices 
under section 201(h) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 321(h)).
    These software products are designed to receive and store data 
used by blood establishments during the manufacturing process, from 
determining donor suitability through component processing, testing, 
and labeling to product release. They are designed to receive and 
store data regarding blood donor status, including donors' answers 
to health history questions and the results of laboratory tests, 
including blood grouping and typing, hepatitis, and antibody to the 
human immunodeficiency virus (anti-HIV). Blood establishment 
personnel later access and use the data to determine whether donors 
are suitable and whether blood or blood components are free from 
disease-causing agents transmissible by blood, such as hepatitis and 
HIV. In addition, the data are used to label blood and blood 
components prior to release for use in hospitals and other health 
care facilities or for further manufacturing. Because they aid in 
the prevention of disease (e.g., hepatitis, HIV, etc.) by 
identifying unsuitable donors and preventing release of unsuitable 
blood and blood components for transfusion or for further 
manufacturing use, these software products meet the definition of 
device under the act.
    Facilities that manufacture and distribute these software 
products are subject to the device provisions of the act and FDA's 
device regulations, including establishment registration, product 
listing, premarket notification or approval, Current Good 
Manufacturing Practices (CGMP), and adverse event reporting. FDA's 
CGMP regulations for devices appear at Title 21, Code of Federal 
Regulations (CFR), Part 820 and the MDR regulations at 21 CFR, Part 
803.
    According to FDA's information, your facility manufactures 
software intended for use in the manufacture of blood and blood 
components. Consequently, you are 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.
    We are enclosing a registration package for your convenience. We 
will forward a device listing package to you in the near future. 
When completing the device listing form (Form FDA 2892), identify 
your product as Software, Blood-Bank, Stand Alone Products, Product 
Code 75MMH. The registration form should be submitted within 60 days 
of receipt of this letter if you intend to continue to distribute 
software products to blood establishments for use in manufacturing.
    In addition, you are required to submit a premarket notification 
or application for premarket approval for each of your devices 
unless you can demonstrate that you commercially distributed the 
devices in interstate commerce prior to May 28, 1976 (the date of 
enactment of the Medical Device Amendments) and have continued to do 
so without any significant changes to these devices. If you claim 
such preamendment status for any product(s), please complete only 
the registration form, and send it to: Center for Devices and 
Radiological Health (HFZ-300), 2098 Gaither Road, Rockville, MD, 
20850.
    If you do not intend to submit a premarket submission, and 
intend to submit proof of the claimed preamendment distribution, 
this information should be sent to: Center for Biologics Evaluation 
and Research (CBER), Division of Blood Applications (HFM-370), 1401 
Rockville Pike, Rockville, MD, 20852-1448. Finally, if you do not 
currently manufacture software products for blood establishments, 
please advise CBER promptly.
    When we forward the product listing information to you, we will 
include guidance on how to prepare your premarket submissions. If 
you have questions about the content or format of a premarket 
submission once you have reviewed our guidance, CBER staff are 
available to help answer such questions. Premarket submissions 
should be submitted to CBER no later than March 31, 1995.
    In the interim, FDA will continue to conduct inspections of 
blood establishment software vendors. These inspections will 
include, among other things, a review of your standards for software 
development, testing, validation, and quality assurance. The primary 
focus of these inspections will be to assess compliance with the 
CGMP regulations for devices (21 CFR, Part 820).
    The agency will also review and assess your procedures for 
investigating reports of product problems and defects and for 
implementing and evaluating corrective actions. We will also review 
and assess your procedures for notifying your customers and the 
agency when you take corrective actions.
    Please be advised that during this interim period if a 
manufacturer of software products for blood establishments is not 
making good faith efforts to comply with the act and FDA's 
regulations as stated above, the agency will not hesitate to take 
the appropriate steps to bring the firm into compliance.
    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 (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.
Sincerely yours,
Kathryn C. Zoon, Ph.D.
Director
Center for Biologics Evaluation and Research

    Dated: August 19, 1994.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 94-21389 Filed 8-30-94; 8:45 am]
BILLING CODE 4160-01-F