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FDA Issues Final Rule on Medical Device Classifications

The U.S. Food and Drug Administration (FDA) has published a final rule that brings its medical device classification requirements in line with current medical device regulations.

Published earlier this week in the Federal Register, the final rule, entitled “Medical Device Classification Procedures: Incorporating FDA Safety and Innovation Act Procedures,” updates and clarifies Part 860 (Medical Device Classification Procedures) of Title 21 of the Code of Federal Regulations so that they are consistent with the provisions of the FDA Safety and Innovation Act (FDASIA). The FDASIA came into effect in 2012 and established new processes for premarket approval (PMA) applications and for the classification and reclassification of medical devices.

In a press release, the FDA clarifies that the final rule does not make “substantive changes” to existing practices for the classification and reclassification of devices, but instead simply provides “greater clarity” around the classification and reclassification procedures.

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Read the text of the FDA’s final rule regarding medical device classification procedures as published in the Federal Register.

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