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

article image
ARTICLE SUMMARY:

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.

  Trial MyStrategist.com and unlock 7-days of exclusive  subscriber-only access to the medical device industry's most trusted strategic publications: MedTech Strategist & Market Pathways. For more information on our demographics and current readership  click here.

 

×



Articles from David Filmore:

Regulatory & Reimbursement

CDRH Departures and Delays, Medtech Tariffs Pushback, and More

In this week’s Pathways Picks: More scientists and reviewers are leaving FDA’s device center, and at least one prominent device lawyer says their departures have already caused tangible delays; CMS plans Parkinson’s and tremors device coverage meeting; US and Europe medtech groups align on message to zero out medtech tariffs; German insurers seek digital health reforms; and more from the US, Norway, and China.

Read Article