21 CFR Part 809 IVD
21 CFR Part 806 CORRECTION&REMOVAL
21 CFR Part 803 MDR 邦訳
21 CFR Part 803 MDR
21 CFR Part 801 Labeling
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]
Refuse to Accept Policy for 510(k)s
Guidance for the Content of Premarket Submissions for Software Contained…
General Principles of Software Validation (pdf版)