March 20, 1997
Irwin Memorial Blood Centers 3/20/97 Blood Center Please be advised that the agency’s memorandum dated April 6, 1988, entitled “Recommendations for Implementation of Computerization in Blood Establishments” indicates as a data security issue that “if key elements of the database are changed, these changes should be traceable as to the time and person making the...
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Cordis Corporation 3/19/97 Stent Delivery 2. The validation of the balloon forming machines conducted from April 1995 to February 12, 1996 is inadequate due to the following: A. The Programmable Logic Controller which controls the balloon forming machine was not qualified.
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What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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