Pre-Market Testing Guidance Pilot Program Released by FDA

Pre-Market Testing Guidance Pilot Program Released by FDA

The FDA is implementing a body of accredited testing facilities to streamline the medical device testing process internationally. The agency has released final guidelines for the program today (9/25) outlining the steps medical device companies must take in order to...
EU Gives Five New Guidances for Medical Devices

EU Gives Five New Guidances for Medical Devices

The European Commission’s Medical Device Coordination Group (MDCG) posted five new guidances on Friday (4/24) for medical devices in light of COVID-19. These guidances are used when demonstrating equivalence to existing devices,...
EU Unanimously Votes to Delay EU MDR by 1 Year

EU Unanimously Votes to Delay EU MDR by 1 Year

In a unanimous decision on Wednesday (4/22), the European Union has decided to push back the amendment to the EU MDR by one year amidst the COVID-19 pandemic. This extra time will allow more time to ensure the functionality and design of the new system, while also...