The U.S. FDA announced a pilot program for electronic submissions for requests for designation (RFDs) for combination products at the agency’s Office of Combination Products (OCP). The scope of the pilot would include both RFD and pre-RFD submissions and would accept up to nine participants. Pilot testing is scheduled to commence Aug. 26, but will be preceded by a period of training of unspecified duration, which also entails submission of a mock RFD filing. The OCP estimates that each organization’s participation will require roughly 15 hours over a span of two weeks.
The U.S. Centers for Medicare and Medicaid Services (CMS) posted the draft hospital outpatient fee schedule for calendar year 2021, which proposes to do away with the inpatient-only (IPO) list altogether over the course of three calendar years. CMS proposes to eliminate roughly 300 entries for musculoskeletal-related services in the first of the three years, and is seeking feedback on whether three years is an appropriate time frame for doing away entirely with the IPO. The agency has received five applications for device pass-through payment, including for the Customflex artificial iris by Clinical Research Consultants Inc., of Cincinnati, and the Exalt model D single-use duodenoscope by Boston Scientific Corp., of Marlborough, Mass. The agency is taking comment through Oct. 5, 2020, under file code CMS-1736-P. BioWorld will cover the draft OPPS in greater detail in a future issue.
The Medical Device Manufacturers Association (MDMA) said it has signed a letter along with more than 450 other organizations in support of the Safe to Work Act (S.4317), which the letter said would provide “temporary and targeted” relief from liability lawsuits for health care professionals and makers of medical devices and diagnostics. The bill, sponsored by Sen. John Cornyn (R-Texas) and referred to the Senate Judiciary Committee July 27, provides liability protection through to Oct. 1, 2024, or when the public declaration of emergency expires, whichever occurs first. The legislation does not preempt worker’s compensation claims nor shields the named parties from any actions arising from allegations of discrimination.
The Advanced Medical Technology Association (Advamed) announced Aug. 4 that total U.S. shipments of molecular diagnostics for the COVID-19 pandemic numbered roughly 100 million on July 25, a figure derived from data at the Advamed testing registry. Advamed said the registry compiles data provided by diagnostics manufacturers and publicly available data on the volume of tests performed each day “to create a centralized and standardized COVID-19 diagnostic supply registry.” Advamed’s president and CEO, Scott Whitaker, said the 100-million test mark “represents yet another extraordinary milestone as the medical technology industry ramps up to meet the demand for testing posed by the coronavirus pandemic.” Whitaker said industry “will continue to work 24/7, around the clock, to ensure widespread availability of test kits and supplies, doing everything possible to help beat this public health crisis.”