Center Director Jeffrey Shuren says it was not CDRH’s intention to force more 510(k)s for device modifications with its July 2011 draft guidance. The center plans to take the unusual step of issuing a revised draft to respond to industry complaints.
FDA’s device center is reworking its controversial draft 510(k) modifications guidance with the intent to issue a revised draft before finalizing a new policy.
CDRH Director Jeffrey Shuren signaled the plans during an April 18 user fee reauthorization hearing before the House Energy & Commerce Health Subcommittee. Republicans on the subcommittee, citing widespread complaints...
The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.
Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.
Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.
