153
!
.
.
–
CDRH
Regulation Performance Standard according to the Food, Drug, and Cosmetic Act
1990
Class I.
,
,
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug
Administration (FDA)
(DHHS).
.
CDRH
,
.
–
CDRH
!
:
,
,
.
.
5
770–795
.