U.S. Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) recently introduced the Rare Device Innovation Act and the FDA Regulatory Efficiency Act.  The bills, if passed, would streamline the U.S. Food and Drug Administration (FDA) approval process for a number of medical devices.  A press release from Senator Gardner states that “this legislation allows the FDA to spend more time reviewing new breakthrough technologies and expedite them to the market for patients who need them.”

According to the press release, the Rare Device Innovation Act makes it easier for medical devices to qualify for expedited approval.  In order to qualify for the expedited approval process under the current Humanitarian Use Device (HUD) program, medical devices must treat diseases that exist in fewer than 4,000 patient cases, annually, in the U.S.  The Rare Device Innovation Act proposes to increase that number to 8,000, which according to the press release will “create[] 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.”  Devices covering diseases like ALS, cerebral palsy, Hodgkin’s lymphoma, mesothelioma, and tuberculosis would qualify under the bill, according to Senator Gardner’s press release.

As outlined in the release (and as a major departure from present FDA practice), the FDA Regulatory Efficiency Act seeks to allow accredited third-parties to perform initial reviews of 510(k) medical devices. Medical devices that qualify under 510(k) are low-risk medical devices that are substantially similar to those already approved by the FDA. Examples of qualifying devices include powered wheelchairs, shunts, and CT scanners.

Regarding the proposed FDA Regulatory Efficienty Act, Senator Donnelly’s press release states: “The legislation would still hold companies accountable for their quality systems, while also helping to alleviate the overwhelmed FDA.”

The proposed third-party 510(k) review appears to have some degree of industry support.  In fact, AdvaMed (the “Advanced Medical Technology Association”) recently commended Senators Donnelly and Gardner on introduction of the FDA Regulatory Efficiency Act.   JC Scott, senior executive vice president, government affairs, for the Advanced Medical Technology Association stated:

This legislation 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 [pre-market approval applications] and ‘special 510(k)s’ for 510(k) products . . . .  This new program will helps ensure that companies are accountable for this minor changes while lessening the burden on FDA, allowing the agency to focus on higher-priority activities . . . .  We look forward to working with members of Congress, FDA and other key stakeholders to move this important legislation forward.