Bill > S2187

This bill, titled the FDA Regulatory Efficiency Act, establishes a third-party quality system assessment program to streamline the review process for certain changes to medical devices. Under this program, accredited third-party organizations will assess a device manufacturer's quality system, which encompasses the methods and controls used for designing, manufacturing, and labeling devices, to ensure it can reasonably guarantee the safety and effectiveness of "in-scope devices" subject to "device-related changes." Device-related changes are defined as modifications to devices that would typically require a premarket notification, a 30-day notice, or a Special PMA supplement, but do not alter the device's intended use or fundamental scientific technology. If the third-party assesses the quality system as meeting established criteria, they can certify it, allowing the manufacturer to bypass certain submission requirements to the Secretary of Health and Human Services (referred to as the Secretary). The Secretary will generally rely on these certifications, though they retain the authority to review, deem provisional, suspend, or cancel a certification if further information is needed or if the assessment is deemed unwarranted. The program includes provisions for accreditation processes, guidance development, reporting requirements for manufacturers, and a sunset clause, meaning the program will cease to be effective on October 1, 2022, with an evaluation and report to be completed before that date.