Q&A: FDA’s LDT Inaction Catches Veteran Attorney Off-Guard
Industry experts expected the US FDA to swiftly reverse a Trump-administration policy blocking oversight of lab-developed tests. Its inaction has one former agency attorney wondering why.
You may also be interested in...
FDA Widens Scope In Considering Evidence For Off-Label Use
After much wrangling, the US agency finally clarified its position on what evidence can determine "intended use" of a product – and industry is not happy.
Q&A: Unpacking The Latest VALID Act For Diagnostics
Covington & Burling partner Scott Danzis tells Medtech Insight why diagnostics developers and labs should keep an eye on the third iteration of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act – reintroduced in the US Senate on 24 June – and why the bill has a better shot at becoming law this time.
Legal Experts: HHS Policy Change Strips FDA Of Oversight For All LDTs
Three lawyers tell Medtech Insight that the recent move by the US HHS to revoke the FDA’s authority to oversee laboratory developed tests extends to all LDTs, and not just those used to test for COVID-19.