Shawn M. Schmitt
Executive Editor
Latest From Shawn M. Schmitt
Speaking Of Medtech, Ep. 10: FDA’s TAP Pilot
In this FINAL EPISODE of Speaking Of Medtech: The US FDA got something it desperately wanted in its latest user-fee package with industry: a Total Product Lifecycle Advisory Program pilot, or TAP. The agency says TAP will allow for earlier and more frequent engagement with developers – but is it needed?
Thumbs Up: FDA Authorizes Weight Loss Suturing Systems From Apollo Endosurgery
People with obesity now have new tools to help them lose weight, thanks to the US agency’s de novo authorization.
FDA Slaps High Risk Class I Label On Recall Of COVID-19 Diagnostics Made In Uncontrolled Plant
More than 160,000 of the tests were recalled, including 104,900 COVID Test Kits Nonsterile and 61,500 Clean Catch Urine Kits.
Meet DHCOE Acting Chief Brendan O’Leary, FDA’s New Digital Health Guru
In this revealing interview, the new acting director of the US FDA’s Digital Health Center of Excellence talks about his new role at the DHCOE, the big shoes he’ll have to fill now that former center head Bakul Patel is gone, the need for new regulatory frameworks for digital health – and how he helped repair the Hubble Space Telescope.
Q&A: FDA Chief Califf Talks Clinical Trial Diversity, Using AI/ML For Inspections, User Fees, And More
The commissioner of the US agency, Robert Califf, answered questions on a variety of timely issues at a 12 July fireside chat. Here are three key takeaways for medtech.
FDA Releases Plan For Enhancing eMDR Adverse Event Reporting System
The US agency has announced some changes it plans to make to its electronic Medical Device Reporting system over the coming year.