US FDA urged to close loophole allowing 510(k) clearance of Class III devices
This article was originally published in SRA
All high-risk medical devices that were allowed on to the US market by the Food and Drug Administration under the less-stringent premarket notification or 510(k) review process should undergo full-blown premarket approval and the FDA should take immediate steps to frame supporting regulations, the Government Accountability Office says in a report1.
You may also be interested in...
Five new drugs have been recommended for EU approval at the latest meeting of European Medicines Agency’s drug evaluation committee.
The European Commission has set aside, for now, concerns expressed by member states regarding the scope of medicines subjected to additional monitoring requirements.
A new work sharing pilot has been launched to evaluate jointly generic drugs intended for launch in Singapore and Malaysia.