Senate Bill Seeks To Expedite FDA Device Review Process

By Jof Enriquez,
Follow me on Twitter @jofenriq

U.S. Sens. Richard Burr (R-N.C.) and Al Franken (D-Minn.) recently introduced the FDA Device Accountability Act (The Device Act) — a new measure intended to speed up the U.S. Food and Drug Administration’s (FDA’s) regulatory approval process for medical devices.

According to a news release from Sen. Burr’s office, the Device Act seeks a more consistent and meaningful application of the "least burdensome" principles specified in the FDA Modernization Act of 1997 (FDAMA), enabling device manufacturers to bring their innovative and life-saving products to patients more quickly.

The release states that FDAMA did not change the statutory requirements for the FDA’s medical device review and approval standards, but only required that the process be conducted in the "least burdensome" manner, which the Device Act seeks to ensure by:

• Requiring the Secretary of Health and Human Services to ensure that FDA reviewers receive training regarding the intent and application of the least burdensome requirements
• Requiring an audit by the FDA ombudsman, as well as an assessment of the measurement used to track the implementation of the least burdensome requirements
• Requiring FDA reviewers to consider the least burdensome appropriate means necessary for demonstrating a reasonable assurance of safety and effectiveness when requesting additional information from manufacturers during the pre-market approval process.
• Requiring the FDA to disclose how it considered and applied the least burdensome requirements in its rationale for significant decisions

The Device Act also will allow sponsors of device trials to seek approval using either a local or a centralized institutional review board (IRB), just like the FDA allows for drug clinical trials. Specifically, the act calls for the use of centralized IRBs to hasten multi-center clinical trials, as these studies have been noted to bog down the current approval process.

“America is a global leader in medical research, development, and innovation,” Burr stated.  “Ensuring that safe medical devices are developed and reviewed quickly will help get them to patients faster, which will improve and save lives.  This legislation will also help cut down on the total time it takes for patients to benefit from approved medical devices by permitting more efficient clinical trials.”

The legislation also requires that the FDA update its guidance on waiving Clinical Laboratory Improvements Act (CLIA) requirements. Specifically, guidance should indicate that point-of-care diagnostic tests that perform the "same in the hands of untrained users as… in the hands of laboratory professionals" may be administered in CLIA-waived labs (e.g., a doctor's office).

The Advanced Medical Technology Association (AdvaMed) issued a statement praising the filing of the new Senate bill.

“AdvaMed commends Sens. Richard Burr (R-N.C.) and Al Franken (D-Minn.) for introducing the FDA Device Accountability Act, which will make improvements to FDA’s medical technology review process and help ensure more timely patient access to the latest medical innovations," stated the release.

AdvaMed considers the improvement of the FDA's regulatory process as one of the five pillars of its “Innovation Agenda.” In a guest column for Med Device Online, AdvaMed president and CEO Stephen J. Ubl described the regulatory approval process as "still unnecessarily time-consuming and inconsistent," despite some progress in efforts to streamline it.