ADVAMED LTR to FDA CDRH Director on Part 11

ADVAMED and NEMA sent a letter to Dr. Feigal (Director of FDA’s Device Center) raising concerns about Part 11 based on a recent meeting with FDA.
They are objecting to the return of Part 11 responsibility to the drug center with no formal device center involvement and the potential that the drug center will issue a new guidance in final form without going through a draft review process with industry.

The full letter is at the link provided.  Advamed-NEMAPart11Ltr2DrFeigal021203

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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