In a new temporary guidance document from the US FDA, the agency says while it’s still meeting its deadline obligations for premarket applications under its user-fee agreement with industry, it may end up missing future deadlines due to strains on the agency from COVID-19. In such cases, the FDA says it will get back to the sponsor about setting a new estimated deadline.
The US Food and Drug Administration may miss future user-fee deadlines as it grapples with the ongoing COVID-19 pandemic, according to a 22 June emergency guidance document from the agency. In such situations, it will issue a letter to the product sponsor explaining the delay and a new estimated date for the decision.
Since the coronavirus crisis hit, the FDA has been busier than ever not only trying to do its part to...
Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
