Minnesota Lawmakers Implore FDA to Use Caution in 510(k) Changes

As the FDA closes in on its self-imposed deadline for announcing changes it would like to make in the 510(k) device clearance process, it is receiving more pressure from lawmakers to make sure the changes are necessary. In a letter to FDA Commissioner Margaret Hamburg, Minnesota’s congressional delegation once again expressed concerns about the impact possible changes could have on medical innovation. “Prompt access to new treatments and cures should be a key consideration in any proposed changes to the 510(k) process,” the bipartisan letter says.
Devices & Diagnostics Letter