The Food and Drug Administration is proposing to amend its regulations governing classification and reclassification of medical devices to conform to provisions in the FDA Safety and Innovation Act (FDASIA). Published today in the Federal Register, the proposed rule would simplify the classification process as Congress directed in the 2012 FDASIA legislation.
"FDA is proposing these revisions to update its regulations to reflect these and other changes, and to ensure classification of devices in the lowest regulatory class consistent with the protection of the public health and the statutory scheme for device regulation," states the proposed rule.
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