Medical Devices

A pharmaceutical economics professor says the federal government should consider creating an agency, separate from FDA, of which the sole purpose would be to track drug use, create multiple drug shortage lists and develop shortage mitigation strategies.

FDA will limit its feedback on emergency use authorization requests for COVID-19 diagnostic tests to just one round of questions in order to quickly move through submissions and make decisions on the applications, the agency told COVID-19 test developers on Wednesday (Dec. 2).

FDA quietly updated its online testing FAQs to reflect HHS’ directive Monday (Nov. 16) that the agency review emergency use authorization applications voluntarily submitted for COVID-19 laboratory-developed tests.

HHS has directed FDA to review emergency use authorization applications voluntarily submitted for COVID-19 laboratory-developed tests -- reviews that FDA told labs in October it would no longer conduct following HHS’ controversial August pronouncement that FDA lacked jurisdiction over LDTs.

A recently developed FDA risk assessment tool shows that while N95 masks are the most effective at protecting the wearer from COVID-19 viral droplets, homemade facial coverings still help flatten the COVID-19 curve.

As of Wednesday afternoon (Nov. 4), it was unclear which party will take control of the Senate, but either way the Senate health committee will experience a change in leadership, as committee Chair Lamar Alexander (R-TN) will retire at the end of the year.

CMS on Tuesday (Oct. 27) proposed a 2021 durable medical equipment pay rule that would permanently hike pay for rural areas, expand coverage of continuous glucose monitors, codify procedures for determining pay for new DME and expand coverage of external infusion pumps for certain drugs.

FDA updated its COVID-19 antigen test template Monday (Oct. 26) to recommend certain test developers seeking emergency use authorization include studies to support claims for screening asymptomatic patients, point-of-care testing and tests measuring multiple infections.

CMS announced that, since August, it has sent 171 cease-and-desist letters to labs that the agency says are not properly certified, a move that a medical device lawyer asserts could be an attempt by CMS to increase public trust in laboratory-developed tests in light of HHS’ controversial move to scrap FDA oversight of LDTs, including for COVID-19.