"SPECIAL" 510(K)S FOR LABELING CHANGES MAY BE ALLOWED UNDER REVISED 510(K) MODIFICATION GUIDANCE; MANUFACTURING CHANGES MAY NOT REQUIRE 510(K)S
This article was originally published in The Gray Sheet
Executive Summary
FDA is considering the use of "special" 510(k) submissions to simplify the addition of warnings, precautions, contraindications and clarifications to labeling of devices cleared through the premarket notification process, according to agency staffers.