Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures
Information
Type
Rule
Regulated products
Medical Devices
Published
December 17, 2018
Last updated
December 17, 2018
Description
Document number 2018-27015. The Food and Drug Administration (FDA, the Agency, or we) 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)