US FDA “raising 510(k) bar” for IVDs
This article was originally published in RAJ Devices
Manufacturers of in vitro diagnostic devices assessed under the US Food and Drug Administration’s 510(k) premarket notification procedure are becoming subject to more stringent reviews with less flexibility allowed for responses to requests from reviewers. This is the view of industry consultant Glenn Neumann.
You may also be interested in...
The US healthcare reform proposals signed into law on 23 March include requirements on medical device companies to reveal payments or gifts they make to doctors. Peter Rixon takes a closer look at what the reforms’ “sunshine” provisions actually mean
Compliance, approvals, inspections and many other burning issues will be on the agenda of a US conference that takes place in early May.
Compliance, approvals, inspections and many other burning issues will be on the agenda of a US conference that takes place in the coming weeks.