The Senate Health, Education, Labor and Pensions Committee passed S. 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act.
The legislation is the Senate’s version of user fees reauthorization, including the Medical Device User Fee Amendments agreement (MDUFA V) between the medical technology industry and the FDA. The Senate committee action follows full House of Representatives passage of its version of the legislation last week. Scott Whitaker, president and CEO of AdvaMed, the world’s largest trade association representing medical technology companies, made the following comment on the Senate committee work.
“A well-functioning user fee system is essential to help ensure FDA’s timely review of innovative medical technology for patients. AdvaMed appreciates the timely work of each chamber of Congress to reauthorize this critical system with improvements to make the process better. MDUFA V has historic firsts, including provisions for greater accountability, predictability, consistency, and communication to increase patient access to safe, effective medical innovations,” AvaMeda says in a release.
“AdvaMed supports additions in the manager’s amendment, as passed, that also would make a difference for patients. The manager’s amendment rightly clarifies when and how the FDA must issue ‘Certificates to Foreign Governments’ (CFGs) to show that devices meet applicable FDA requirements. Many countries require CFGs, but the FDA has been inconsistent in how it applies them. The legislative language would ensure consistency so the products the FDA already deemed safe and effective could be imported and exported more efficiently, reaching more patients.
“The manager’s amendment includes the bipartisan Verifying Accurate, Leading-edge IVCT Development (VALID) Act on diagnostic tests. AdvaMed strongly supports the underlying intent of the VALID Act to establish a modernized, comprehensive regulatory framework for all diagnostic tests. Whether developed in a lab or through an FDA-approved manufacturing facility, diagnostic tests should be regulated consistently and reflect the modern state of test development. The committee rightly kept the long-awaited VALID Act intact amid attempts to weaken it.
“AdvaMed supports an amendment approved by the committee that would allow the FDA to grant predetermined change control plans (PCCPs), allowing a device manufacturer to submit proposed postmarket device modifications with its initial submission to the FDA. PCCPs enable timely updates to products that will benefit patients. This would be especially useful as new technologies come to market, such as artificial intelligence and machine learning.
“AdvaMed also welcomes committee passage of an amendment creating a report to Congress and the public on the FDA’s receipt and use of emerging signals for postmarket device safety concerns. Building transparency into how the agency receives information about device performance ultimately would help patients.
“AdvaMed thanks the HELP committee members and their staff for their valuable work and looks forward to answering any questions as both chambers of Congress continue to advance this important legislation.”