The Food and Drug Administration (FDA) is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also making additional changes unrelated to the FDASIA requirements, to update its regulations governing the classification and reclassification of medical devices. FDA is taking this action to codify the procedures and criteria that apply to the classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.
This Regulatory Impact Analysis discusses the economic impacts of this final rule, including potential costs, cost savings, and benefits. The costs of this final rule include those incurred by the Agency and industry related to preparation and participation in additional panel meetings. The principal benefits of this final rule stem from the reduction in regulatory and economic burden that will accompany the elimination of some paperwork filing requirements, in addition to the enhanced consistency and uniformity across reclassification proceedings. These cost savings will accrue to both medical device manufacturers and to the Agency. Further benefits may be derived from the decreased time a petition will need to be reviewed for device reclassification, and the subsequent potential benefits realized by consumers and producers.
Regulatory Impact Analysis
Federal Register: 83 FR 64443, December 17, 2018