Medical Design and Outsourcing2d
FDA’s Tarver pushes for mandatory medical device shortage reporting
The FDA is urging Congress to implement mandatory medical device shortage reporting to address growing vulnerabilities in the ...
JD Supra9d
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 ...
Forbes1mon
Are The FDA’s New Regulations On Medical Devices Making A Difference?
In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity. They issued new requirements for premarket submission and ongoing monitoring by medical ...
Hosted on MSN18d
FDA 510(K) Approved Facilities: Increasing GMP Inspections And Compliance Requirements
Indian medical device manufacturers are prioritizing GMP compliance to meet rising global healthcare demands. Success in inspections requires proactive planning, strong management commitment ...