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Medical Devices

December 03, 2020 | Daily News

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).

December 03, 2020 | Daily News

A top FDA device center official said on Wednesday (Dec. 2) that the agency hopes to soon publish an emergency use authorization template for prescription at-home COVID-19 serology tests that detect antibodies to SARS-CoV-2.

November 19, 2020 | Daily News

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.

November 18, 2020 | Daily News

FDA issued its first emergency use authorization for a rapid COVID-19 diagnostic that can be performed entirely at home late Tuesday (Nov. 18) night and hopes to approve similar tests in the upcoming weeks.

November 16, 2020 | Daily News

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.

November 13, 2020 | Daily News

FDA announced on Thursday (Nov. 12) that it’s considering giving medical technology company Advion Inc. patent rights to a mass spectrometer diagnostic device that can be used for the rapid detection of SARS-CoV-2 and other viruses, bacteria and drug impurities, coming amid a global call for mass spectrometry to be used in detecting COVID-19.

November 12, 2020 | Daily News

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.

November 11, 2020 | Daily News

Device industry lawyers believe the new session of Congress will try to push forward legislation giving FDA regulatory authority over laboratory-developed tests, coming after the Trump HHS made headlines in August by unexpectedly announcing FDA lacked legal authority to regulate LDTs, including COVID-19 tests developed by labs.

November 04, 2020 | Daily News

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.

October 30, 2020 | Daily News

FDA on Friday (Oct. 30) released a list of 223 essential drugs and biologics and 96 device medical countermeasures, nearly three months after the White House directed the agency to issue the list as part of the Trump administration’s so-called buy American executive order that was signed in August.

October 27, 2020 | Daily News

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.

October 26, 2020 | Daily News

HHS and FDA are once again clashing over laboratory-developed tests. An HHS official tells Inside Health Policy that labs can still voluntarily seek emergency use authorization of COVID-19 LDTs to get liability protection even though the department axed FDA’s regulation of the tests in August, but FDA told labs on Oct. 7 it would no longer accept voluntarily submitted EUAs for the tests.

October 26, 2020 | Daily News

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.

October 16, 2020 | Daily News

Medicare next year will cut pay for labs that take more than two days to turn around COVID-19 test results, CMS announced Thursday (Oct. 15).

October 13, 2020 | Daily News

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.

October 08, 2020 | Daily News

FDA on Wednesday (Oct. 7) quietly updated its COVID-19 testing frequently asked questions webpage to say it will no longer review emergency use authorization requests for laboratory-developed tests for COVID-19.

October 01, 2020 | Daily News

FDA on Wednesday (Sept. 30) authorized OralDNA Labs’ oral rinse COVID-19 diagnostic test, which the company asserts could help resolve supply chain bottlenecks, coming as FDA officials express concern about potential supply shortages heading into flu season.

September 28, 2020 | Daily News

FDA’s latest clarification of the types of evidence it will use to determine whether companies intend for drugs and devices to be used off-label removes language that industry argued would have unfairly exposed companies to misbranding violations.

September 28, 2020 | Daily News

FDA recently launched its new Digital Health Center of Excellence with the goal of promoting digital health research and partnerships. However, one industry expert says he has doubts about the intent of the program, asserting that it could just be a marketing move to push the agency’s device precertification program.

September 22, 2020 | Daily News

The House again passed two bipartisan bills that aim to give FDA authority to destroy counterfeit medical devices and that direct the agency to establish centers of excellence focused on continuous manufacturing.