Part 11 Implementation and Guidance Update

Last fall John Taylor, Director, FDA Office of Enforcement took over as leader of the agency’s Part 11 Compliance Committee.
As of January 2001:
1. The draft guidances on Validation and Glossary of Terms are now in formal review at the agency. This does not mean they are close to final.
2. FDA has suspended work on the other guidances it had been working on, in order to concentrate on the guidance of highest priority, on Scope. The committee has asked each of the FDA Centers for their interpretations of scope, and will use these as input to the process.

The Part 11 industry coalition of trade associations will provide input and feedback regarding each guidance.

SoftwareCPR Keywords: Electronic Records Signatures, erec, esig

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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