Part 11 Industry Coalition Update

In 2000, a coalition of trade associations was formed to provide input to FDA regarding interpretation of Part 11. This unusual effort across industries has been undertaken due to the global nature of the rule and the cost and impact of compliance to the rule depending on interpretation.

The initial group of six national trade associations was formed in May, 2000 and has now expanded to eight representing the food, innovator drug, generic drug, OTC drug, device, animal drug, cosmetic, and dietary supplement industries. The current membership is summarized below:

1. Advanced Medical Technology Association (AdvaMed):
2. Consumer Healthcare Products Association (CHPA):
3. Cosmetic, Toiletry and Fragrance Association, (CTFA):
4. Council for Responsible Nutrition (CRN):
5. Generic Pharmaceutical Association (GPhA):
6. National Food Processors Association (NFPA):
7. Pharmaceutical Research Manufactures of America (PhRMA):
8. Animal Health Institute (AHI):

The full text of the Jan 2001 update by the coalition is at the link provided.

SoftwareCPR Keywords: Electronic Records Signatures, erec, esig

Part11 Coalition – Jan 2001

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:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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