By Surabhi Dangi-Garimella, PhD
User fee agreements—whether for a medical device or a prescription drug—create a path for manufacturers to get their product reviewed in a systematic manner by the FDA. The Medical Device User Fee and Modernization Act of 2002, known as MDUFMA or MDUFA, was signed into law in October 2002 to grant new responsibilities and resources to the FDA and to speed up the approval process. Product developers can expect faster reviews so patients can have earlier access to innovative devices.
Under MDUFA’s provisions, medical device manufacturers have to pay the assigned fee for certain applications, reports, application supplements, and submissions that they present for FDA review. This does not, however, include devices that may be sponsored by the federal or state governments. Small businesses may be eligible for lower fees.
MDUFA also opens up a path for appropriations, including for the post-market surveillance (performance data of a marketed device that is collected, analyzed, and interpreted) of medical devices. However, it restricts the use of these fees to cover the cost of the resources that the FDA allocates for the review process.
The MDUFA user fees are renewed every five years, which leaves MDUFA IV up for renewal in September 2022.
MDUFA Update and the VALID Act
Bipartisan efforts from both the House and the Senate members have revived the Verifying Accurate Leading-edge IVCT Development (VALID) Act, which was first introduced in 2020. VALID Act will create a new class of products within the FDA’s jurisdiction called in vitro clinical tests (IVCTs) that will include both in vitro diagnostic products manufactured by device manufacturers and those developed within a single clinical laboratory—the lab-developed tests (LDTs)—which are currently regulated by CMS as CLIA tests.
The act intends to give a facelift to the review process for diagnostic products and also clarify the distinct roles that the FDA and CMS will play in regulating the products and the laboratories that develop these products. It was referred to the House Energy and Commerce Subcommittee on Health in June 2021.
Surabhi Dangi-Garimella, Ph.D. is a biologist with academic research experience, who brings her skills and knowledge to the health care communications world. She provides writing and strategic support to non-profit groups via her consultancy, SDG AdvoHealth, LLC.