The FDA’s Modernization of Certain Aspects of Regulation (MoCRA) brings pivotal changes to how medical devices are regulated in the United States. MoCRA emphasizes enhanced safety and efficacy standards, aiming to streamline approval processes while ensuring rigorous oversight. Key components include updated classification criteria, stricter pre-market requirements, and comprehensive post-market surveillance. Device manufacturers must now …
Navigating FDA’s MoCRA Requirements for Medical Devices