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

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.