What to Make of Substantive Objections to FDA’s Intended Use Revisions?

Claud Mccoid

By Patti Zettler, Affiliate Professor, Georgia State College University of Law and CLB Fellow alumna

Cross-posted on Goal Intent

As I have formerly created about here, in January Fda revealed a controversial revision to its restrictions defining “intended use,” and then, in the wake of procedural and substantive objections to the revised definition, the agency delayed the helpful date of the new rule until eventually March 2018.  These revisions are crucial mainly because the “intended use” of a item is crucial for determining no matter whether the item is a drug or machine subject to Fda jurisdiction at all, and if so, no matter whether the drug or machine is in compliance with numerous Fda specifications.  Appropriately, there is significant curiosity in the sorts of proof that Fda considers appropriate to determining a product’s intended use.  The January revision to FDA’s restrictions defined that that Fda would use a “totality … Read More