Warning Letter Roundup & Recap – April 9, 2019
Executive Summary
In the only device-related warning letter released by the US FDA this week, Inova Genomics Laboratory was dinged for selling products without premarket approval.
You may also be interested in...
FAQ Sheet From HHS Says FDA ‘Rarely Enforced’ Premarket Review Of LDTs
The US HHS defends its recent decision to relieve the FDA from oversight of laboratory developed tests in a new FAQ sheet, saying the agency hardly ever enforced the premarket review of LDTs in the first place.
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.