YAKHAK HOEJI

Table. 4. Table 4

Classification of FDA for medical devices by risk^10,11)

	Class I	Class II	Class III
Risk	Low	Moderate	High
Approval process	PMN (almost exempt)	PMN	PMA
Regulation	General controls	General controls Special controls	General controls PMA
Example	Medical rubber gloves, Surgical camera, etc.	Contact lens, Blood or liquid infusion pumps, etc.	Heart valves for implantation purposes, etc.