COVID-19: CDRH Staff Leaves Door Open For Some LDT Safety Oversight
Executive Summary
US FDA staff spoke on HHS’s new laboratory developed test edict, as well as ongoing concerns around new test types and reviewer responsiveness in a recent virtual town hall.
You may also be interested in...
Pressure On Medtech Companies High, And Recalls Frequent, Amidst COVID-19
Medical device manufacturers are operating in what may be the industry’s most challenging business and regulatory environment in recent history, attorneys Bill McConagha and Pamela Amaechi argue in this guest article.
Spurred On By HHS Policy Shift, AdvaMed Chief Wants LDT Reform In User-Fee Negotiations
The medical device advocacy group plans to include laboratory developed test reform in their upcoming user-fee negotiations with the US FDA.
Top FDA Officials Explain Standards For Take-Home COVID-19 Tests
In an op-ed, two top US COVID-19 regulators say they have a lower threshold for sensitivity for take-home tests to encourage development and increase access to them.