ARTICLE SUMMARY:
In this week’s roundup: Members of Congress press HHS to reverse Trump laboratory developed test (LDT) policy, the European Commission makes an appeal for more IVDR notified bodies, China issues reclassification procedures, South Korea refines virtual reality oversight, Stryker seeks 510(k) exemption, and dates to remember on MCIT, exam gloves, and MDR.
Diagnostic Picks
Dx policymaking will be active in 2021:
Lawmakers press on LDTs. Leading House Democrats are calling on FDA to reassert its premarket review authority for laboratory developed tests (LDTs) for COVID-19. House Energy and Commerce Committee Chair Frank Pallone (D-NJ) and Reps. Anna Eshoo (D-CA) and Diana DeGette (D-CO), chairs of the Health and Oversight and Investigations Committees, respectively, wrote to HHS Secretary Xavier Becerra May 11, calling on him to reverse the Trump-era department’s recission notice last August, ruling that FDA couldn’t require review of LDTs without pursuing formal rulemaking. (See “COVID Testing Conundrum Feeds FDA Resource, Reform Debates,” Market Pathways, September 14, 2020.
