AdvaMed on Device EUA Transition Plan

AdvaMed says it appreciates FDA efforts to develop proposed transition plans dealing with medical devices issued emergency use authorizations during the Covid-19 emergency and medical devices under Covid-19 enforcement policies. The company’s comment letter thanks FDA “for its commitment to help provide a clear transition process to help device manufacturers transition back to normal operations when the public health emergency expires and its work to support continued flexibility and appropriate oversight to facilitate an orderly and transparent phased approach to such transition while considering the unique challenges of this pandemic and product considerations … and taking care to minimize disruption of critical medical supplies.”

The letter includes specific comments on the agency’s proposed information collection and promises future comments on the proposed transition plans and specific questions for feedback associated with the draft guidances.