Q&A: Harvard Professor Talks JAMA Study That Looks At 45 Years Of FDA Premarket Data
The study concludes that the regulatory process has become complex and the path to market for some medical devices tricky.
You may also be interested in...
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.