A Deep Dive With US FDA’s Suzanne Schwartz: COVID-19, Cybersecurity, Device Shortages, And More
As head of the device center’s emergency response program, Schwartz oversees a broad range of issues, from medical device shortages to cybersecurity vulnerabilities. We talk to her in this Medtech Insight profile.
You may also be interested in...
New FDA Device Cybersecurity Director Isn’t New To The Issue
Kevin Fu, a University of Michigan associate professor, has been named the US agency’s acting director of medical device cybersecurity. In his new post he’ll be able to mold the agency’s regulatory approach.
One-Two Punch Of HHS Rules On Guidance Docs, Regs Will ‘Tie Hands’ Of Biden Admin: Expert
Two new rules put forward by the US HHS could have a chilling effect on future guidance documents and regulations drafted by the FDA and the 27 other agencies and offices the HHS oversees, a policy expert says. This and other stories topped our list of most-read US regulation, policy, quality control and compliance articles in December.
Head Of New Digital Health Center Looking For A Few Good FDA Staff
Bakul Patel, director of the US agency’s new Digital Health Center of Excellence, tells Medtech Insight he’s looking to hire staff that want to shape the digital health regulatory landscape.