Section 506J of the Federal Food, Drug, and Cosmetic Act requires manufacturers of certain devices to tell the FDA in advance if they are permanently ending production of the product or face an interruption that is likely to meaningfully impact supply before or during a public health emergency (PHE). The FDA released draft guidance on the topic for consultation last year.
In response, AdvaMed said “it is vital for FDA to publish a list of procodes that are subject to the section 506J reporting requirement.” The request, which was echoed by the Medical Device Manufacturers Association, reflected a belief that FDA’s attempts to clarify the scope of the reporting requirements had failed to clear up uncertainty.
