Regulatory News

Senators Introduce Two Bills to Streamline FDA Reviews of Medical Devices

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:

• the bipartisan Combination Product Regulatory Fairness Act of 2015, which intends to support and accelerate FDA's review of drug-device combination products
• the bipartisan Advancing Breakthrough Devices for Patients Act of 2015, which would streamline the review process for breakthrough devices that do not have an approved alternative
• the