Premarket notification (510(k)); except for third part

上市前通知- 适用绝大数二类医疗器械，约占90%。

Premarket Approval Application (PMA

上市前批准- 适用于三类医疗器械，约占20%。

Product Development Protocol (PDP)

Premarket Report (PMR)

Modular PMA

30 Day Notice

513g Request For Information

De Novo Request