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