ISPE iSpeak blog
October 7, 2019
Amy Scanlin
Category Archives: EAS in the News Medical Device
510(k) Guidance Shifts Away Substantial Equivalence in Favor of Performance Testing and Criteria
MedTech Intelligence
April 11, 2019
Jay Mansour
FDA Encourages Innovation and Safety as Part of Medical Device Regulatory Overhaul
MedTech Intelligence
Amy Scanlin
December 7, 2018
Expanded Use of De Novo Pathway Offers Opportunity for Device Manufacturers
MedTech Intelligence
Amy Scanlin
April 23, 2018