The House Energy & Commerce Committee’s health subcommittee Thursday voted unanimously to approve the latest version of the 21st Century Cures Act, which aims to reduce the regulatory burden on devicemakers through third-party audits while accelerating the development of novel treatments.
The vote confirms a provision, included in Wednesday’s third discussion draft, allowing FDA-accredited third parties to conduct inspections related to relatively minor device design changes, such as those made under 30-day supplements or special PMA supplements. They would not replace FDA investigators for more broad regulatory inspections.
Following an assessment, the FDA would have 30 days to review the results before they were considered final, the measure says. Third parties would be paid by the devicemakers who hired them, not by the FDA. The subcommittee made no changes to the measure
The bill’s third-party audit provision hews closely to the ongoing Accredited Persons Inspection Program, which was first authorized as part of device user fee legislation in 2002. That pilot program allows the FDA to recognize third parties to assess the quality systems of eligible devicemakers, determine compliance with existing regulations and report their findings back to the FDA, which then makes the final compliance assessment.
Success in a third-party audit replaces a regular FDA inspection. The agency has accredited 14 bodies to perform inspections.
The FDA would be required to issue draft guidance on the 21st Century Cures third-party program within 12 months of the measure’s passage, followed by final guidance no more than a year later. A report evaluating the third-party program’s results would be due in 2022.
The measure replaces a late April version that had dropped third-party audit language (IDDM, May 1).
The measure adopted by the subcommittee also would establish a breakthrough pathway for innovative devices, allow for a broader range of data to be considered in device approvals, require new guidance on the least-burdensome provision and on the use of recognized standards in the device approval process, and set rules limiting the FDA’s ability to regulate software as a medical device.
The full committee will consider the measure, which has not been assigned a bill number, next week, and the plan is to get a bill to the House floor by June and have it on the president’s desk by the end of the year. There is no comparable measure in the Senate.
View measure at www.fdanews.com/05-14-15-third-draft.pdf. — Elizabeth Orr