FDA Device Chief Okay With Cures Breakthrough Plan, But Lacks Funding

FDA medical device chief Jeffrey Shuren said he is comfortable with the breakthrough devices provision in the House 21st Century Cures Act, but he worries the agency might not have enough funding to implement it if the bill is passed into law. Shuren said the Cures provision basically codifies the approach taken by FDA in its recently launched expedited device approval program for premarket approval and de novo devices, even though the bill extends the priority review process to 510ks...