Use of Safety and Performance to Determine Substantial Equivalence – FDA Issues New Guidance for Medical Devices

Posted on October 7, 2019October 8, 2019

510(k) Guidance Shifts Away Substantial Equivalence in Favor of Performance Testing and Criteria

Posted on April 11, 2019July 30, 2019

MedTech Intelligence

April 11, 2019

https://www.medtechintelligence.com/column/510k-guidance-shifts-away-substantial-equivalence-in-favor-of-performance-testing-and-criteria/

Jay Mansour

FDA Encourages Innovation and Safety as Part of Medical Device Regulatory Overhaul

Posted on December 7, 2018January 30, 2019

MedTech Intelligence

FDA Encourages Innovation and Safety as Part of Medical Device Regulatory Overhaul

Amy Scanlin

December 7, 2018

Expanded Use of De Novo Pathway Offers Opportunity for Device Manufacturers

Posted on April 23, 2018January 15, 2019

MedTech Intelligence

Expanded Use of De Novo Pathway Offers Opportunity for Device Manufacturers

Amy Scanlin

April 23, 2018