Senate Bill Would Allow 510(k) Condition-Of-Clearance Studies
Legislation introduced Dec. 15 would give FDA PMA-like authorities over 510(k) devices, including the power to require post-clearance studies. Industry says the bill is unnecessary.
Legislation introduced Dec. 15 would give FDA PMA-like authorities over 510(k) devices, including the power to require post-clearance studies. Industry says the bill is unnecessary.