[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
