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Medical Devices

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.

September 18, 2020 | Daily News

FDA’s latest report on its software precertification program shows the agency is investing substantial time on the new project, despite not having statutory authority or answering key questions from the industry, device software industry lawyers say.

September 17, 2020 | Daily News

Newly published performance data for COVID-19 laboratory-developed tests show FDA’s desire to be more transparent with test developers and, according to a medical device industry lawyer, could persuade labs seeking to manufacture tests to pursue FDA authorization, even though they’re no longer required to have premarket or emergency authorization from the agency.

September 11, 2020 | Daily News

Top FDA device center officials call for the United States to create a legislative framework for overseeing lab tests and to work with global partners to devise a plan for sharing clinical specimens to ensure diagnostic testing is accurate and reliable in future pandemics.

September 08, 2020 | Daily News

The Laboratory Corporation of American (LabCorp) introduced the first combined diagnostic test for COVID-19, influenza A/B and respiratory syncytial virus (RSV) on Tuesday (Sept. 8).

September 04, 2020 | Daily News

A group of Democratic representatives want three major commercial laboratories to increase pooled testing for COVID-19, specifically in New Jersey, New York and Connecticut, in order to increase testing output while preserving critical supplies.

September 02, 2020 | Daily News

The American Nurses Association wants the Trump administration to invoke the Defense Production Act for N95 masks to help resolve shortages of masks and other personal protective equipment, which it says would help cut down on the reuse and decontamination of masks that are intended only for single-use.

August 31, 2020 | Daily News

CMS on Monday (Aug. 31) proposed a rule to streamline Medicare coverage of breakthrough technologies, more than a year after the White House Office of Management and Budget began reviewing it, although one policy analyst says the proposed definition of “reasonable and necessary” is the rule’s most significant provision.

August 31, 2020 | Daily News

Drug and device industry lawyers are surprised that FDA’s latest inspection guidance fails to expand on whether and how the agency will use remote technologies to conduct facility inspections during the COVID-19 pandemic.

August 27, 2020 | Daily News

FDA on Thursday (Aug. 27) issued its first emergency use authorization (EUA) to a COVID-19 antigen test where the results can be read directly from the testing card, similar to a pregnancy test.

August 26, 2020 | Daily News

A rapid point-of-care breath test for COVID-19 could be commercially available by the fall of 2020, the ECRI Institute asserts in a report published Wednesday (Aug. 26).