Sens. Cory Gardner (R-CO) and Joe Donnelly (D-IN) late Wednesday announced the introduction of two new bills that would further streamline the US Food and Drug Administration (FDA) approval process for certain medical devices.
One of the bills -- the Rare Device Innovation Act -- would expand the threshold by which FDA could approve medical devices that treat rare diseases, including ALS, cerebral palsy, Hodgkin’s lymphoma, mesothelioma and tuberculosis.
Currently, FDA has an expedited approval process for devices intended to treat or diagnose rare diseases that are present in 4,000 patients or fewer in the US annually, and this bill would increase that number to 8,000 patients.
"By increasing the threshold from 4,000 to 8,000 patient cases, the Rare Device Innovation Act creates an incentive for manufacturers to develop medical devices for rare diseases to help people with rare conditions gain access to technologies they would not otherwise," Gardner said in a statement.
FDA Regulatory Efficiency Act
In addition, the senators introduced another bill, known as the FDA Regulatory Efficiency Act, which provides FDA with the authority to transfer the initial review of medical devices seeking approval via the 510(k) pathway to agency-accredited third parties.
These authorized third parties would only be able to approve devices that do not involve major technology changes or changes in the use of a product, the senators said.
Devices currently approved via the 510(k) pathway are low-risk and have to be substantially similar to devices that have already been approved.
"By allowing accredited third parties to conduct the initial review of these devices, this legislation allows the FDA to spend more time reviewing new breakthrough technologies and expedite them to the market for patients who need them," Gardner said. Donnelly also noted that the bill would still hold companies accountable for their quality systems.
Medical Innovation Agenda
In addition to the introduction of these two bills, Donnelly also threw his weight behind three other bills, including:
US medical device industry group AdvaMed offered its support for both bills.
J.C. Scott, AdvaMed's senior executive vice president, government affairs, said in a statement that the FDA Regulatory Efficiency Act “would create a voluntary program under which medical technology companies could have their quality system certified by an FDA-authorized third party. This certification would allow companies to self-certify certain low-risk changes to currently marketed devices. These changes would be limited to minor alterations to an existing product or manufacturing process currently covered by 30-day notices for PMAs [premarket approval applications] and ‘special 510(k)s’ for 510(k) products."
Gardner Press Release
Donnelly Press Release