The Problem of the ‘Intended Use’ Regulations Continues to Fester

March 21, 2017By: Jeffrey K. Shapiro Download PDF

In 2015, FDA proposed revising the so-called A1:I298 use regulation (21 CFR 201.128; id. § 801.4) to remove the famous ‘knowledge’ sentence:

But if a manufacturer knows, or has knowledge of facts that would give him notice, that a [drug or device] introduced into interstate commerce – is to be used for conditions, purposes, or uses other than the ones for which he offers it, he is required to provide adequate labeling for such a drug/device which accords with such other uses to which the article is to be put.