Out-of-office email responses may be the most some in industry can expect from FDA during the ongoing partial government shutdown.
In particular, new PMA and 510(k) submissions, and anything else tied to a user fee payment, are not being reviewed...
Shutdown Realities At FDA: No New Submission Reviews, And More
New PMA and 510(k) submissions, and anything else tied to an FY 2014 user fee payment, are not being reviewed by FDA as of Oct. 1. The limited carryover-FY 2013 user fees FDA has are supporting ongoing reviews, while the registration and listing and export certification database entry systems are unavailable.
More from Regulation
• By
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.
• By
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.
• By
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
• By
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
More from Policy & Regulation
• By
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
• By
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
• By
Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.