Congressional Research Service: 'FDA Regulation of Medical Devices' (Part 3 of 3)
January 10, 2023
January 10, 2023
WASHINGTON, Jan. 10 -- The Congressional Research Service issued the following report (No. R47374) on Jan. 4, 2023, entitled "FDA Regulation of Medical Devices:"
(Continued from Part 2 of 3)
* * *
Special Controls
Special controls are the additional regulatory requirements put in place for moderate-risk (class II) devices because general controls do not provide reasonable assurance of safety and effectiveness. A special control is gen . . .
(Continued from Part 2 of 3)
* * *
Special Controls
Special controls are the additional regulatory requirements put in place for moderate-risk (class II) devices because general controls do not provide reasonable assurance of safety and effectiveness. A special control is gen . . .