RAPS

GAO: Medical Device Reviews Taking Longer Despite FDA Meeting Goals

The US Government Accountability Office (GAO) released a report Thursday (29 March) indicating it found the US Food and Drug Administration (FDA) to be meeting its performance goals for medical device ...
RAPS

CDRH, CBER Finalize Medical Device Review Communication Guidance

A new guidance document released by the US Food and Drug Administration (FDA) is intended to clarify the types of communication used by FDA and industry during the review of medical device submissions ...
The New York Times

F.D.A. Firings Decimated Teams Reviewing A.I. and Food Safety

Staff units evaluating high-tech surgical robots and insulin-delivery systems were gutted by Trump layoffs even though industry fees, not taxpayers, financed the employee salaries. By Christina Jewett ...
MD&M East

Factors Influencing FDA Clearance Time for Medical Devices: Evolution of a Critical Regulatory Pathway

The landscape of FDA medical device regulation has undergone a significant transformation. Today's regulatory environment presents both familiar challenges and entirely new complexities that device ...
FierceBiotech

FDA formally kicks off medical device user fee negotiations

The FDA formally kicked off its quinquennial process to reauthorize the federal user fee legislation that helps fund its medical device reviews by hosting discussions with the medtech industry and ...