21st Century Cures Act

Published 2016-12-26

On December 13th, 2016 President Obama enacted the 21st Century Cures Act. The act has multiple provisions pertaining to Regenerative Medicine. Section 3033 allows FDA to grant accelerated approval for regenerative therapeutic products. Section 3034 classifies medical devices for regenerative medicine therapeutic products as moderate risk devices unless otherwise deemed appropriate.

These provisions will likely have a significant impact on the arrival of new Regenerative Medicine products and devices to the market.

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