AdvaMed Proposes ‘MAHA’ Pathway for Devices
In a recent submission to the Trump administration, the Advanced Medical Technology Association (AdvaMed) outlined a series of recommendations aimed at strengthening U.S. leadership in medical technology and safeguarding national security amid reliance on imported devices, personal protective equipment and medical consumables.
AdvaMed proposed the creation of a new regulatory route, dubbed the “MAHA” (Make America Healthy Again) pathway, to expedite FDA review of medical technology products developed and manufactured domestically. The pathway would cover submissions through the 510(k), PMA, and de novo processes and aim to reduce review times related to manufacturing or supplier changes.
The association emphasized that such a pathway could also facilitate accelerated coverage and payment for new technologies not yet included under Medicare benefit categories. According to AdvaMed, this approach would reward U.S. investment in research, development, and manufacturing, while providing American patients first access to advanced medical solutions and helping maintain U.S. leadership in the global medtech market.
The group also urged FDA to increase inspections of foreign medical device manufacturers to a level comparable with U.S. facilities. AdvaMed highlighted that domestic manufacturers typically face greater regulatory scrutiny, creating an uneven playing field. The recommendations called for risk-based surveillance inspections, particularly in regions where on-site investigations are challenging or where post-market reporting rates are unusually low.
Additionally, AdvaMed flagged concerns over the integrity of data from third-party testing laboratories abroad, citing reports of fabricated or unreliable data. The organization proposed granting FDA authority to immediately suspend labs with credible indications of fraud, publish warnings to alert manufacturers, and remove noncompliant labs from the agency’s Accreditation Scheme for Conformity Assessment (ASCA) program.
Finally, AdvaMed recommended leveraging FDA approvals to streamline international market access for American medtech products. By encouraging key foreign markets to recognize FDA approvals, the “America First” approach would incentivize companies to launch their most innovative products first in the U.S., ensuring American patients gain earlier access to life-saving technologies.
The association pointed to existing momentum, noting that countries such as the United Kingdom and Switzerland already rely on FDA clearances for market entry. AdvaMed highlighted the strategic importance of securing similar agreements with Mexico, given its role in the North American supply chain, and expanding reliance efforts to emerging markets in Latin America and Southeast Asia.