According to a news release from Burr’s office, the FDA Device Accountability Act (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 claims the FDAMA did not change the statutory requirements for the FDA’s medical device review and approval standards, but only required 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 on 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 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 premarket approval process; and
- Requiring the FDA to disclose how it considered and applied the least burdensome requirements in its rationale for significant decisions.
“America is a global leader in medical research, development, and innovation,” Burr said. “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 and Al Franken 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.”