JD Supra1d
FDA Publishes Guidance on Medical Device Shortages During Public Health Emergencies
Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal ...
Medical Design and Outsourcing7h
FDA finalizes guidance for device shortage notifications
The FDA has issued a revised guidance on medtech manufacturers' obligations to notify the agency of manufacturing ...
FDA moves to ban Red 3, citing concern over cancer in some animals
FDA officials have telegraphed the decision for months. While the agency has long said that it did not think evidence of Red ...
Fierce Healthcare1d
HHS' new AI strategic plan promises increased guidance and funding
AI is safe and trustworthy when deployed in healthcare. The plan emphasizes technical assistance for under-resourced ...
Modern Healthcare9d
FDA drafts guidance for AI developers
The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
Food8d
FDA sets ‘achievable’ lead levels for baby food – but are they still too high?
Final guidance from FDA affirms previously proposed caps for lead in packaged baby and toddler food that public health advocates complained did not go far enough – spurring calls for state action.