Medical Devices Bill $298 Million in 21st Century Cures Act: CBO
The Congressional Budget Office is estimating that medical device provisions in the proposed 21st Century Cures Act, if implemented by the U.S. FDA, would cost at least $298 million from 2016 to 2020, according to a report issued last week.
The House Energy & Commerce Committee unanimously approved the bill, H.R. 6, in May.
It has not gone to the House floor and no similar legislation exists in the Senate.
The legislation would ease U.S. device clinical trials by allowing a single central review board to monitor multiple trial sites.
Currently, device trials must be cleared by a local IRB at each research site.
Additionally, the FDA reform package simplifies informed consent rules around device trials posing “no more than minimal risk to the human subject,” as long as they include appropriate safeguards.
The CBO breakdown on medical devices includes:
- $158 million to establish a program to provide expedited review of devices that represent breakthrough technologies where no approved alternatives exist and the technology offers significant advantages over existing alternatives;
- $68 million to establish an accreditation program for third parties to expedite the approval process for certain devices, review and recognize national and international standards, and develop and update guidances and regulations;
- $68 million to implement a new framework for the regulation of medical software; and
- $4 million for the FDA’s Center for Devices and Radiological Health to issue final guidance on the review of combination products. The guidance is due within 18 months of H.R. 6’s adoption and would be updated regularly.
The bill also includes a provision to establish a Cures Innovation Fund, which would encourage public-private partnerships and award grants to foster the collection, analysis and availability of data on the natural history of disease and support initiatives of the Council for 21st Century Cures. The CBO estimates that spending from the fund would total $327 million over the 2016-2020 period