Cures Bill Lets Third-Parties Decide If A Device Can Skip 510(k) Process

An evolving provision in House lawmakers' draft 21st Century Cures bill would give third-party reviewers authority to decide whether changes to medical devices are minor enough to allow device makers to skip sending premarket notifications to FDA under the 510(k) process. A device industry lawyer doubts the provision as written will advance because of how much power it vests in third parties to determine what constitutes a minor device change. The provision, drafted by Rep. John Shimkus (R-IL), says lawmakers...