FDA, 医疗器械的一般规定(Genreal Control)

 

General Control
FD&C Act Section 501, 502, 510, 516, 518, 519,520

 

需要FDA进行登记的医疗器械分类产品，需共同遵循General Control。

 

大部分Class I 510(k) 提交例外对象只需满足General Control所要求的事项即可。

Class II - 510（k）

Class III - PMA

产品也应符合各自Special Control和PMA要求事项和General Control的要求。

 

​ - 501: Adulterated devices (器械污染)

- 502: Misbranded devices (记录出错)

- 510: Registration of producers of devices (产品及设施登记)

· Establishment registration and device listing

· Premarket Notification (510k)

· Reprocessed single-use devices

- 516: Banned devices (禁止器械)

- 518: Notifications and other remedies (事后管理)

· Notification

· Repair

· Replacement

· Refund

· Reimbursement

· Mandatory recall

- 519: Records and reports on devices (装置记录和报告)

· Adverse event report

· Device tracking

· Unique device identification system

· Reports of removals and corrections

- 520: General provisions respecting control of devices intended for human use (GMP)

· Custom device

· Restricted device

· Good manufacturing practice requirements

· Exemptions for devices for investigational use

· Transitional provisions for devices considered as new drugs

· Humanitarian device exemption

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