The CDC released consolidated recommendations for COVID-19 testing, including interim guidelines for nursing home residents and health care personnel, as well as testing strategy options for high-density critical infrastructure workplaces after a COVID-19 case is identified. These recommendations compile and update previous guidance. The consolidated recommendations for testing, Overview of Testing for SARS-CoV-2, were developed based on what is currently known about COVID-19 and are subject to change.
The U.S. FDA has scheduled an Aug. 13 public workshop, titled “Spinal Device Premarket Review,” that is intended to enhance understanding of the agency’s review of data and information submitted to support premarket authorization for spinal devices falling under 21 CFR 888.3070 and 21 CFR 888.3080 by highlighting key sections of a 510(k) submission. It is targeted toward members of the orthopedic community, device manufacturers and industry consultants, informing them on FDA-issued product-specific and general guidances, with an eye toward submission quality and promoting efficient review of orthopedic premarket applications. The event is webcast only, with registration due Aug. 3.
House Energy and Commerce Committee Chairman Frank Pallone (D-N.J.) and Communications and Technology Subcommittee Chairman Mike Doyle (D-Pa.) sent a letter to Federal Communications Commission (FCC) Chairman Ajit Pai requesting additional transparency on the distribution of public funds through the COVID-19 Telehealth Program, which Congress created in the CARES Act. Specifically, Congress appropriated $200 million to the FCC to address the coronavirus “by providing telecommunications services, information services, and devices necessary to enable the provision of telehealth services.” The FCC said that as of June 10, it had awarded more than $104 million in appropriated funds through the COVID-19 Telehealth Program. The representatives assert that many details of these awards are known only to the FCC. The duo has asked the FCC to take certain actions by June 19, updating certain information weekly. These actions are providing on its public facing website a docket that includes all of the applications the commission has received for the program; detail which applications have been approved; provide the date on which funds were actually dispersed for approved applications; and create a summary of any uses or devices that were not approved for reimbursement.
The U.S. Senate’s Committee on Health, Education, Labor and Pensions (HELP) has scheduled a June 23 hearing, titled “COVID-19: Lessons Learned to Prepare for the Next Pandemic.” HELP Chair Sen. Lamar Alexander (R-Tenn.) issued a white paper June 9 identifying COVID-19-related areas that must be addressed – accelerating R&D for tests, treatments and vaccines; improving infectious disease surveillance; rebuilding stockpiles and improving the medical supply surge capacity and distribution; improving local and state public health capabilities; and improving coordination of federal agencies during a health emergency.