Two US senators have drafted a bill they say will bring more transparency and consistency to FDA device facility inspections.
New Bill Aims To Bring Consistency, Transparency To US FDA Inspections
US Sens. Johnny Isakson, R-Ga., and Michael Bennet, D-Colo., introduced legislation that calls for adopting a uniform FDA inspection process to ensure parity between audits of foreign and domestic device firms, notifying manufacturers in advance of records that will be requested during an inspection, and specifying a window of time for investigators to conduct their onsite inspections, among other requirements.
More from Regulation
More from Policy & Regulation
• By
A concealed blunt-tip needle that can be inserted into the heart's pericardial space to treat cardiac arrhythmias has received FDA clearance, providing an alternative to catheter-based methods.
• By
Biomedical Alliance’s Tom Melvin is on a mission to assist the European Commission comprehend the clinical gaps during its ‘targeted evaluation’ of the EU's medtech regulations and the pivotal role the EMA could play.
• By
The FDA staff cuts will probably mean longer device review times at least in the short term, speakers said at a recent webinar. But innovations like AI and third-party review could offer some hope, even as tariffs create a new set of problems.