CDRH Finalizes Guidances on 510(k) Submissions

As part of its ongoing overhaul of the 510(k) process, CDRH released finalized guidances on its special 510(k) and abbreviated 510(k) programs, on its refuse-to-accept policy for 510(k)s and on formatting recommendations for submissions.

The programs are evolving to reflect advances in materials, digital health, 3D printing and other technologies, as the agency moves ahead with its Medical Device Safety Action Plan unveiled last year.

“The most impactful way that we can promote innovation and improved safety in the 510(k) program is to drive innovators toward reliance on more modern predicate devices or objective performance criteria when they seek to bring new devices to patients,” said CDRH Director Jeffrey Shuren, in announcing new steps to modernize the program late last year.