Regulatory Affairs Professionals Society

FDA to exempt five more unclassified devices from premarket notification

The US Food and Drug Administration (FDA) announced its intent on Thursday to exempt certain unclassified medical devices ...
Medical Design & Outsourcing

FDA rules, regulations and resources for artificial intelligence in medical devices

Medtech developers incorporating AI or machine learning into medical devices need to recognize if and how FDA will regulate ...
RAPS

FDA updates manufacturer communications guidance to emphasize application to devices

The US Food and Drug Administration has updated its draft guidance on how the drug and medical device makers should communicate with payors and other stakeholders about their products. The updates are ...

FDA Cyber Guidance Sets Priorities for Medical Device Companies

Opinion: In response to the FDA's updated cybersecurity guidance on medical devices, manufacturers should follow "secure by design" principles, ensure cyber transparency, conduct threat modeling, and ...