Medtech Matters
Medtech Matters
Medical Product Outsourcing
To Regulate or Not to Regulate…Lab Developed Tests, Part 1
43 minutes Posted Jan 31, 2023 at 1:00 pm.
0:00
43:35
Download MP3
Show notes
In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we look at the debate over lab developed tests (LDTs) and whether or not the FDA should have the authority to regulate them. What would this type of oversight do to the need for speed with these types of tests? Would FDA supervision make things safer and also avoid future situations like the Theranos debacle? Specifically, the following questions are addressed between the two parts of t...