Universal incident reporting form
This article was originally published in The Gray Sheet
Executive Summary
Health Industry Manufacturers Association requests 45-day extension to the deadline for comments on a proposal for a device/drug/biologic reporting form. HIMA says it needs the extra time to "confer and meet with our members to develop comments" on the draft. FDA's Feb. 26 proposal set an April 12 deadline for comments ("The Gray Sheet" March 1, I&W-9).