On January 22, 2019, the U.S. Food and Drug Administration (FDA) issued the public notice and opened a docket for comments, "Modernizing the Food and Drug Administration's 510(k) Program."
The FDA is announcing the establishment of a public docket and a request for comments regarding FDA's proposal to consider making public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. As part of FDA's Medical Device Safety Action Plan, the Agency committed to strengthen and modernize the premarket notification (510(k)) program. The FDA is seeking public feedback on whether and how to make information about older predicate devices public, in order to promote the use of more modern predicates.
You may submit comments to the public docket at www.regulations.gov using docket number FDA-2018-N-4751 or by clicking the button below. Please submit comments for consideration by May 22, 2019.