The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff July 2014, 7/28/2014 · The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff . Document issued on: July 28, 2014, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [ 510 ( k )] – Guidance for Industry and Food and Drug Administration Staff (PDF Only) Share Tweet, The 510 (k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510 (k)]: Guidance for Industry and Food and Drug Administration Staff. Final. Issued by: Food and Drug Administration (FDA) Issue Date: July 28, 2014.
The 510 (k) Program: Substantial Equivalence In Premarket Notifications. This guidance was released on July 28, 2014. FDA developed this document to provide guidance about current review practices for premarket notifications (510 (k)) submissions.
11/26/2018 · Thread starter Similar threads Forum Replies Date; M: FDA News FDA Report – FDA Has Taken Steps to Strengthen The 510 ( k ) Program : Other US Medical Device Regulations: 0: Nov 26, 2018: M: Medical Device News FDA – Transformative new steps to modernize FDA’s 510 ( k ) program to advance the review of the safety and effectiveness of medical devices: Other US Medical Device …
