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Medical Devices

August 20, 2020 | Daily News

House Energy & Commerce Committee Chairman Frank Pallone (D-NJ) demanded a briefing from HHS Secretary Alexander Azar on why the department decided it will no longer require laboratory developed tests to undergo FDA premarket reviews before coming to market.

August 20, 2020 | Daily News

FDA will no longer require premarket review for laboratory developed tests, including tests developed to diagnose COVID-19, HHS announced Wednesday (Aug. 19).

August 19, 2020 | Daily News

HHS Assistant Secretary Brett Giroir praised a newly approved COVID-19 rapid point-of-care test for its low cost, quick turnaround time and flexible platform that will help give patients a quicker diagnosis, as well as possibly help scale up testing and increase patient access to care.

August 17, 2020 | Daily News

Despite reassurance of "excess" COVID-19 testing supplies from the White House, FDA revealed in its first medical device shortage list posted late Friday (Aug. 14) that there are shortages of COVID-19 testing equipment such as swabs, reagents, storage and transport devices and instrumentation systems due to the public health emergency

August 17, 2020 | Daily News

FDA gave its first emergency authorization for a saliva-based COVID-19 diagnostic test that does not require any special swab or collection device on Saturday (Aug. 15) in the hopes of increasing testing capacity and reducing the current strain on testing equipment.

August 14, 2020 | Daily News

The Congressional Research Service says at-home and over-the-counter COVID-19 diagnostic tests that don’t require a physician’s order and could be quickly read at home, similar to an at-home pregnancy test, would improve testing access, capacity and turnaround time and would facilitate testing in any setting at any frequency, including homes, workplaces and schools.

August 14, 2020 | Daily News

Third-party medical device servicers say they support Senate Finance Committee ranking Democrat Ron Wyden’s (OR) bill that would allow independent service organizations to repair medical devices for the duration of the COVID-19 emergency, though they would like to see the language extended beyond COVID-19.

August 13, 2020 | Daily News

HHS’ new $6.5 million investment in two commercial diagnostic laboratories aims to expand the U.S. testing capacity by 1 million tests per week by utilizing excess supply and expanding the lab workforce, according to Brett Giroir, HHS assistant secretary.

August 11, 2020 | Daily News

FDA is launching a Pandemic Recovery and Preparedness Plan (PREPP) that will apply best practices and lessons learned from the COVID-19 response so far to chart the agency’s response efforts going forward, FDA Commissioner Stephen Hahn said Monday (Aug. 10) during a webinar hosted by the Reagan-Udall Foundation for the FDA.

August 06, 2020 | Daily News

President Donald Trump will sign a “buy American” executive order Thursday afternoon (Aug. 6) that directs FDA to work closely with the Environmental Protection Agency (EPA) to speed domestic approvals of essential medical products, loosen continuous manufacturing regulations, identify supply chain vulnerability, and target dangerous counterfeit drug and medical product imports.

August 05, 2020 | Daily News

FDA last week finalized a review policy for multiple function devices under which it will only review functions for which a device maker seeks clearance or approval.

July 30, 2020 | Daily News

As lawmakers and industry experts criticize lack of federal coordination and slow turnaround times on COVID-19 diagnostic tests, HHS Assistant Secretary for Health Brett Giroir asserted that reports of widespread delays in receiving test results are largely inaccurate and that there are no significant problems with securing testing supplies.

July 30, 2020 | Daily News

The White House budget office is reviewing an FDA proposed rule that clarifies what kind of evidence the agency will consider when determining a product’s intended use.

July 29, 2020 | Daily News

FDA announced Wednesday (July 29) that it will decrease application costs for its prescription drug user fee program in fiscal 2021, but it will increase overall program fees by about $11,000 over fiscal 2020 levels, for a total of about $336,000.

July 28, 2020 | Daily News

HHS and CMS should delay the durable medical equipment competitive bidding process by a year or until the end of the health emergency, whichever is longer, Rep. Cathy McMorris Rodgers (R-WA) says in a letter she’s encouraging her colleagues to sign by Wednesday (July 29).

July 28, 2020 | Daily News

The brand drug lobby and patient groups say the next iteration of prescription drug user fee legislation should expand use of decentralized clinical trials and digital health technologies that can collect data remotely.

July 27, 2020 | Daily News

Senate Republicans’ COVID-19 relief package, introduced Monday (July 27), calls on FDA and the Centers for Disease Control and Prevention to coordinate on efforts to improve and speed development of diagnostic tests, treatments and vaccines for emerging infectious diseases, and to work with stakeholders to identify medical product supply needs for public health emergency response.

July 27, 2020 | Daily News

Senate Judiciary Committee Chair Lindsey Graham (R-SC) and Senate health committee Chair Lamar Alexander (R-TN) introduced bills Monday (July 27) that aim to ramp up domestic procurement and manufacturing of medical products, and provide tax credits to qualifying personal protective equipment manufacturers.

July 24, 2020 | Daily News

The House on Friday (July 24) passed 224-189 an FDA spending package that would give the agency $3.21 billion in discretionary funding, an increase of $40.8 million over fiscal 2020 funding levels, and would provide the agency authority to recall drugs.

July 22, 2020 | Daily News

The Senate on Wednesday (July 22) rejected Sens. Chris Murphy (D-CT) and Tammy Baldwin’s (D-WI) request to pass by unanimous consent a bill that would require President Donald Trump to invoke the Defense Production Act to provide states with medical equipment, such as tests, respirators, gowns and gloves.