Robin Newman is out as director of the Office of Compliance within US FDA's device center, leaving the post after only 18 months on the job. Agency stalwart Bill Maisel has taken her place on an "acting" basis as he leads the effort to create a "super office" that will merge the compliance office, the Office of Surveillance and Biometrics, and the Office of Device Evaluation into one.
Robin Newman is out as director of the Office of Compliance within US FDA's device center, leaving the post after only 18 months on the job. Agency stalwart and top scientist Bill Maisel has been named as acting head.
Newman left FDA on Oct. 20 to join Johnson & Johnson's device unit as worldwide VP for clinical research...
The US FDA posted eight device-related warning letters in June, touching on industry sectors from urinalysis test strips to ophthalmic devices.
“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.
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.
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.
