ARTICLE SUMMARY:
In this week’s roundup: AdvaMed circulates its priorities for Congress; MedTech Europe weighs in on “data space” proposal; IVD Regulation status check-in and new resources; EU “scientific advice” pilot launches; tech assessment updates from Denmark and the UK; first firms enroll in FDA’s TAP pilot; and more.
Advocacy Picks
Trade group takes:
AdvaMed agenda. The trade group’s 2023/2024 US Congress priorities include a mix of specific legislation and more general oversight of federal agencies and global agreements. A few priority bills on AdvaMed’s “innovation agenda” for the 118th Congress are legislation that would codify an accelerated Medicare coverage path for innovative medical devices (in parallel to CMS’ work on a Transitional Coverage of Emerging Technologies regulation); a version of the VALID act to establish a new regulatory framework for diagnostics including laboratory-developed tests; reauthorization of the Pandemic and All Hazards Preparedness Act (PAHPA); and legislation to improve clinical trial diversity by allowing more financial assistance to patients and reimbursement to alternative providers. Other notable components on the wish list:
- Support for policies positive for US medtech in China, Japan, and Europe
- Prioritization of medical applications for semiconductor chips and other in-demand supplies
- Oversight of FDA’s implementation of MDUFA V and other recent FDA reforms
- Scrutiny of EPA’s planned ethylene oxide emission standard updates
- Reinstating an immediate, rather than amortized, federal R&D tax credit
