Congressional Research Service: 'FDA Regulation of Medical Devices' (Part 2 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 1 of 3)
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Medical Device Regulatory Controls
As required by the Medical Device Amendments (MDA), all medical devices are subject to basic regulatory requirements - general controls - intended to provide reasonable assurance of a device's safety . . .
(Continued from Part 1 of 3)
* * *
Medical Device Regulatory Controls
As required by the Medical Device Amendments (MDA), all medical devices are subject to basic regulatory requirements - general controls - intended to provide reasonable assurance of a device's safety . . .