Manufacturers of specific devices must notify the FDA in advance under Section 506J of the Federal Food, Drug, and Cosmetic Act if they plan to permanently stop producing the product or experience a disruption that could materially affect supply before or during a public health emergency (PHE). Last year, the FDA published draught guidelines for discussion on the subject.
“It is vital for FDA to publish a list of procodes that are subject to the section 506J reporting requirement,” AdvaMed said. The request, which the Medical Device Manufacturers Association also made, was based on the idea that the FDA had not been successful in removing any doubt on the extent of the reporting requirements.