Guidance for Industry
Year 2000 Date Change for Computer Systems and
Software Applications Used in the Manufacture of Blood Products
[PDF version]
This guidance document is being distributed for implementation
and comment.
Comments and suggestions regarding this document should be
submitted to Valerie A. Butler, Center for Biologics Evaluation
and Research (HFM-17), Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20857-1448.
For questions regarding this document, contact Nancy Jensen
(CBER), 301-827-3524.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research (CBER)
January 1998
Table of Contents
- INTRODUCTION
- BACKGROUND
- SPECIFIC RECOMMENDATIONS
- REFERENCES
Guidance for Industry1
Year 2000 Date Change for Computer Systems and
Software Applications Used in the Manufacture of Blood Products
- INTRODUCTION
This guidance document is provided to raise awareness that computer
systems and software applications currently used in the manufacture
of blood products may experience problems beginning January 1, 2000,
due to the use of two-digit fields for date representation.
Table of Contents
- BACKGROUND
In June 1997, FDA issued a letter to medical device manufacturers
stating that computer systems and software applications currently
used in medical devices may experience problems beginning
January 1, 2000, due to the use of two-digit fields for date
representation. In addition to adversely affecting the functioning
of some devices, the two-digit date format could also affect
computer-controlled design, production or quality control processes.
To ensure the continued safety and effectiveness of these devices,
FDA recommended several courses of action.
For future medical device premarket submissions, manufacturers
should assure that the products can perform data recording and
computations that will be unaffected by the year 2000 date change.
For currently manufactured medical devices, manufacturers should
conduct hazard and safety analyses to determine whether device
performance could be affected by the year 2000 date change. If
these analyses show that device safety or effectiveness could be
affected, then appropriate steps should be taken to correct
production and to assist customers who have purchased such devices.
For computer-controlled design, production and quality control
processes, manufacturers should assure that two-digit date formats
or computations will not cause problems beginning January 1, 2000.
Under 21 CFR 820, Quality System Regulation, which became effective
June 1, 1997, manufacturers must investigate and correct problems
with medical devices that present a significant risk to public
health, this includes devices that fail to operate according to
their specifications because of inaccurate date recording and/or
calculations. Section 518 of the Food, Drug and Cosmetic Act
requires notification of users or purchasers when a device presents
an unreasonable risk of substantial harm to public health.
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- SPECIFIC RECOMMENDATIONS
- Users of Blood Establishment Computer Systems and Software Applications
Users of blood establishment computer systems and software applications should contact the manufacturer of these
systems to determine the impact that the year 2000 date representation will have on the system software application, database, records, calculations, etc., used in the manufacture of blood products.
A list of those functionalities impacted by design changes made to correct the year 2000 date representation should be obtained from the manufacturer.
All functionalities impacted by design changes made to correct the year 2000 date representation should be validated.
- Manufacturers of Blood Establishment Computer Systems and Software Applications
Manufacturers should investigate the impact of the year 2000 date representation on blood establishment computer software, and correct any design problems with devices in accordance with the June 1997 letter issued by FDA to medical device manufacturers.
Manufacturers should conduct hazard and safety analyses to determine whether device performance could be affected by
the year 2000 date change. Manufacturers should provide the user with a list of those functionalities impacted by
design changes made to correct the year 2000 date representation.
Table of Contents
- REFERENCES
- Letter to Medical Device Manufacturers, dated June 25, 1997, from D. Bruce Burlington, Director, Center for Devices and Radiological Health.
- Quality System Regulation, October 7, 1996, Federal Register (61 FR 52602).
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1
This document represents FDA's current thinking on the year
2000 date change for computer systems and software applications
used in the manufacture of blood products. It does not create
or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternate approach may be used
if such approach satisfies the requirements of the applicable
statute, regulations, or both. Submit written requests for
single copies of this document 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 mail by
calling the CBER Voice Information System at 1-800-835-4709 or
301-827-1800, or by fax by calling the FAX Information System at
1-888-CBER-FAX or 301-827-3844. Persons with access to the
INTERNET may obtain the document using the World Wide Web (WWW).
Connect to CBER at http://www.fda.gov/cber/guidelines.htm.
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