Modernizing the Food and Drug Administration’s 510(k) Program Comment Period Extension

The FDA is extending the comment period by 30 days for the Modernizing the Food and Drug Administration's 510(k) Program: Request for Comments regarding FDA’s proposal to consider making public on its website cleared devices that demonstrated substantial equivalence to older predicate devices. Please submit comments to the docket no later than May 22, 2019. Instructions for submitting comments can be found at www.regulations.govunder docket number FDA-2018-N-4751. 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.