medical devices

Clinical Research Solutions

FDA Issues Draft Guidance to Advance Development of Combination Products

On Tuesday, February 5th, FDA published a draft guidance explaining the principles for premarket review of combination products, including how to determine which type of premarket submission is...

Clinical Research Solutions

FDA Releases Draft Guidance on Benefit-Risk Determinations for Devices

On Thursday, September 6th, the FDA released a new draft guidance regarding benefit-risk determinations in medical device premarket approval applications (PMAs), De Novo requests, and humanitarian...

Prev 1 2