Senate HELP Advances Device Review Reform Bills
This article was originally published in The Gray Sheet
The Senate Health, Education, Labor and Pensions Committee approved a slate of bills Feb. 9, including the Device Accountability Act, which enhances focus on the "least burdensome" concept for device review, and legislation intended to improve oversight of modified devices and device reprocessing.
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Sen. Ron Wyden, D-Ore., ranking member of the Senate Finance Committee, plans to reintroduce chronic-care legislation in 2017 that would lead to more Medicare reimbursement of home-use devices and telemedicine options for elderly patients with multiple conditions.
Following up on recommendations made in her January report on duodenoscope contamination, Senate HELP Ranking Member Patty Murray, D-Wash., introduced a bill pressing FDA to accelerate its work to clarify when 510(k)s are needed for device modifications and to solidify the agency's authority to deny submissions if the sponsor fails to provide validated reprocessing data.
Multiple bills focused on accelerating the path to market for devices will join safety legislation reforming the regulation of duodenoscopes in a slate of Senate bills that HELP Committee Chairman Lamar Alexander said will receive hearings in February, March and April. The legislation-by-legislation approach in the Senate differs from the broad-based 21st Century Cures package that advanced in the House.