On Feb. 23, 2022, the U.S. FDA published the Draft Proposed Rulemaking for the new “Quality Management System Regulation.” It’s imperative that the entire industry thoroughly understand the new proposal and any nuances. This White Paper is Part 2 of a series of technical analyses to help inform any interested parties.
White Paper – FDA Guidance Documents for De Novo Classification Requests
June 29, 2022
1
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