Pathways' Pick of the Week: CDRH Proposes Voluntary Alternative Pathway

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FDA's device center is circulating a proposal for a voluntary program that would allow to pick and choose appropriate regulatory requirements for new technologies. Excerpted from Pathways' Picks October 26: MedTech Conference Takeaways, and More.

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.

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Pathways Picks November 29: Global Disharmony, Brazil Pilot, Software Notified Body, and More

In this week’s roundup: FDA quits Asia-based device harmonization group; Brazil launches innovative device pilot; Australia updates clinical guidance; EU designates its first software-only notified body; industry pushes back on German digital health reforms; House AI hearing; key device lawmaker is retiring; PMA submissions on the rise; comments are coming due on an EU survey and FDA’s LDT proposal; and more global medtech policy updates.

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