The FDA and medtech industry groups have agreed on a medical device user fee deal.
Regulatory Affairs Professionals Society (RAPS) reported that while details are still being negotiated, the FDA reached an agreement on principle on a framework for the Medical Device User Fee Amendment (MDUFA V) on March 7. It will make the deal public once it irons out details.
An FDA spokesperson told RAPS that daily meetings are ongoing to negotiate details of the commitment letter before the draft agreement is published for public comment in “the near future.” After that, there will be a public meeting and the delivery of final recommendations to Congress, the spokesperson said.
RAPS reported that, if enacted, the agreement would double current user fee spending. Even with the doubled fee, the report stated that industry groups “are optimistic the deal will help their companies bring new products to market.”
“The medtech industry is poised to unleash a whole new dimension of innovation for patients in the coming years,” AdvaMed CEO Scott Whitaker said in a statement provided to MassDevice. “This agreement with FDA will unquestionably help innovators to reach that potential. FDA is the global gold standard for device safety and effectiveness, and I want to thank the agency for its commitment and hard work with us throughout the process. We look forward to input and guidance from Congress on the agreement going forward.”