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 ...
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 ...
RAPS

MDUFA Report Touts CDRH Efforts to Improve Medical Device Review Processes

Efforts at the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) to improve the medical device review process under the Medical Device User Fee Amendments of ...
MobiHealthNews

FDA recognizes device interoperability standards, potentially smoothing 510(k) reviews

A decision by the Food and Drug Administration to recognize a set of voluntary, industry-developed interoperability standards should make it easier for technology developers to gain 510(k) clearance ...