The bill aims to provide clarity on a murky area of FDA authority in regulating lab developed tests. Under the Trump administration, HHS shocked the industry in August 2020 when it announced FDA would no longer require premarket review for LDTs, despite the agency long maintaining that these tests are devices and fall under its purview according to the Medical Device Amendments of 1976.
The policy change was issued by HHS, and not FDA, drawing the attention of industry observers who saw it as evidence of internal divisions, with then-HHS Secretary Alex Azar reportedly overriding objections from FDA on the easing of rules applicable to all LDTs covering a wide range of diseases including cancer and COVID-19.
