New draft guidance from the US Food and Drug Administration lays out major factors the agency considers when reviewing 510(k) premarket notification applications to make Substantial Equivalence (SE) determinations.
Die US Food and Drug Administration hat einen neuen Entwurf veröffentlicht, in dem sie die wesentlichen Faktoren bei der Ermittlung der wesentlichen Gleichwertigkeit bei 510(k)-Anträgen vor der Markteinführung erläutert.
The 510(k) premarket notification program is primarily intended for medical devices that are “substantially equivalent” to other medical devices that have previously received market clearance from the FDA.
EMERGO BY UL SUMMARY OF KEY POINTS:
- US FDA has proposed formal policies and criteria for De Novo novel medical device classification requests.
- The De Novo classification route allows some low- and moderate-risk devices for which substantial equivalence cannot be established to obtain US market access.
- The proposed rules would set a 120-day review period for De Novo classification requests.