Year-End Omnibus Includes Key AdvaMed-supported Wins for Patients

WASHINGTON, D.C. – The year-end spending package making its way through Congress includes key provisions championed by the Advanced Medical Technology Association (AdvaMed) that will benefit the patients served by the medical technology companies AdvaMed represents.

AdvaMed released this statement from President and CEO Scott Whitaker on these provisions: “Over the course of the 117^thCongress, AdvaMed has advocated for robust policies that benefit patients, from expanding access to innovative new technologies to ensuring strong oversight for medical devices. With many outstanding issues not addressed by the landmark MDUFA V agreement earlier this year, patient champions in Congress stepped up to ensure bipartisan provisions were included in the final omnibus package.

The Verifying Accurate, Leading-edge IVCT Development (VALID) Act for regulatory oversight of in vitro clinical tests (IVCTs) – including in vitro diagnostics (IVDs) and laboratory-developed tests (LDTs) – was not included in the final package.

Whitaker said: “The VALID Act’s exclusion is disappointing, especially given the strong bipartisan support for both the policy and principles of the proposal: The reforms are intended to level the playing field and set the stage for the next generation of innovation in the diagnostics industry, ensuring all tests are safe, effective, and work as intended.

“Patients have strong advocates on Capitol Hill, and I want to thank Chair Murray and Ranking Member Burr for their leadership on the VALID Act, particularly for including the reforms in the HELP Committee markup of MDUFA V. I also want to thank our bill sponsors Representatives Diana DeGette and Larry Bucshon, and Senator Bennet. We look forward to working with the next Congress to pass this important legislation for patient safety.”

In addition to many of the provisions in the PREVENT Pandemics Act that made it into the final bill, other Medtech provisions in the omnibus include:

• Sponsors of diagnostic tests that have been deemed to be Clinical Laboratory Improvement Amendments (CLIA)-waived under Sec. 564(m) of the FFDCA as part of a COVID-19 emergency use authorization that submit requests for de novo classification of their test may submit such request together with sufficient information to enable FDA to determine whether the test satisfies the criteria for CLIA categorization.
• Clarifies that FDA can issue Certificates to Foreign Governments for medical devices that are manufactured by a device establishment located outside of the United States, if the establishment is registered, the medical device is listed, the device is lawfully marketed and imported or offered for import into the United States.
• Requires FDA to make reasonable efforts to evaluate third-party research on medical devices that is used for regulatory decision-making; and to the extent practicable, provide the manufacturer(s) a summary of such information. 
• Allows the Secretary to approve a predetermined change control plan submitted in an application or supplement that describes planned changes that may be made to the device if the device remains safe and effective. Allows cleared devices to submit a predetermined change control plan in a notification.

The final legislation also reauthorizes:

• The Humanitarian Device Exemption incentive, which exempts the effectiveness requirement for medical devices intended to benefit patients in the treatment or diagnosis of rare diseases through October 1, 2027.
• The Pediatric Device Consortia Program, which supports the continued development of medical devices intended specifically for children.

# # #

AdvaMed is the world’s largest medical technology association, representing device, diagnostics, and digital technology manufacturers that are transforming health care through earlier disease detection, less invasive procedures, and more effective treatments.