We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has issued a warning to patients and health care providers to not use the Synovo Total Hip System including resurfacing implants, manufactured by Synovo Production after 2019, because components of the system have been modified from the cleared device and the safety and effectiveness has not been established. Read More
Encouraging the FDA to put in place rules that govern the use of AI in healthcare is the focus of a letter Rep. Greg Murphy (R-N.C.) has sent to FDA Commissioner Robert Califf, pointing to the need to clarify liability guidance and overlapping governance, both of which he says are undermining manufacturers. Read More
This edition of Quick Notes looks at recent FDA medical device clearances and designations for EndoSound, EndoQuest Robotics, Perfuze, AnX Robotics, CGBio. Read More
CDRH is now issuing electronic export documents for medical devices instead of paper to improve efficiency, reduce the amount of time it takes for a manufacturer to receive export documents, and decrease environmental burden. Read More
The FDA is increasingly finding cybersecurity lapses during inspections of medical device manufacturing facilities — and most often because cybersecurity risk management is not fully documented as part of design controls, according to compliance expert Eric Henry. Read More
The FDA is seeking input from a wide variety of stakeholders on a draft report on best practices for streamlining the development, dissemination and use of guidances. Read More
The current formal agreement “needs to be updated to reflect organizational and procedural changes that have occurred since 2018” the report says. Read More
To regulate new medical device technologies, the FDA should rely on familiar regulatory processes to review low-risk activities while adopting a more attentive approach that devotes greater resources to high-risk activities, according to a former agency commissioner. Read More