ARTICLE SUMMARY:
In this week’s roundup: What we heard at AdvaMed’s confab in Boston, including FDA's Voluntary Alternative Pathway proposal for more agile regulations; disagreements between the International Medical Device Regulators Forum and the World Health Organization on a regulatory model update; CMS mulling a medtech coverage path; and potential for FDA diagnostic regulations. Also: the UK is delaying implementation of its post-Brexit device framework by a year, FDA Breakthrough updates, and more.
Updated 10/27 with Voluntary Alternative Pathway report.
MedTech Conference Picks
AdvaMed held its annual conference in Boston this week. Here are some running updates from the meeting:
Voluntary Alternative Pathway. FDA’s device center is stepping up efforts to build support for legislative reforms that would establish a new flexible alternative regulatory framework for innovative devices, in particular digital health. The hope is to get traction for the issue in Congress next year. The proposal, dubbed the “Voluntary Alternative Pathway,” or VAP, would give FDA authority to take a more customized approach to regulating new technologies in a manner that addresses safety and effectiveness but without unnecessarily slowing down innovation, according to CDRH officials. Without a statutory change allowing more flexible regulatory approaches, “we think we are going to see digital health technologies hit a wall in the next few years, probably in the next five years,” Jeff Shuren, CDRH director, said during an October 26 panel closing out The MedTech Conference in Boston. “We have to fix this.” Shuren has been lamenting the absence of a more agile regulatory framework for several years, but the agency is now engaging in a more formal effort to engage stakeholders and enact legislation to address that goal. (Look for more details on the VAP proposal shortly in Market Pathways.)
IMDRF presses WHO to do better. The World Health Organization has swayed off course in an ongoing effort to revise its harmonized model designed to help developing countries stand up device regulations. So says Melissa Torres, FDA’s associate director for regulatory affairs, who is helping represent the International Medical Device Regulators Forum in the WHO’s effort to update the 2017 Global Model Regulatory Framework (GMRF) for devices and IVDs. “We have had some challenges with a bit of misalignment with international best practices in some cases,” Torres said during a panel discussion at The MedTech Conference October 24 in Boston.
