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GUIDANCE DOCUMENT

Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products Guidance for Industry January 1998

Final

Year 2000 Date Change for Computer Systems and Software Applications Used in the Manufacture of Blood Products

Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

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.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010