FDA Enforcement Policy for Certain Supplements for PMA and HDE Submissions: Overview
The article outlines the key points associated with the enforcement policy related to certain supplements.
The article outlines the key points associated with the enforcement policy related to certain supplements.
The US Food and Drug Administration (FDA) finalized guidance on the Humanitarian Device Exemption (HDE) program on Thursday, reflecting amendments made by the 21st Century Cures Act (Cures Act) and the FDA Reauthorization Act (FDARA). What is the HDE program? The HDE...