Hyman Phelps and McNamara
Firm Publications

The Problem of the ‘Intended Use’ Regulations Continues to Fester
March 21, 2017

In 2015, FDA proposed revising the so-called intended 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.”

In the proposed rule, FDA indicated that removing the sentence was nothing more than a clarification “to better reflect FDA’s interpretation and application of these regulations.” At the time, we blogged very favorably on this change, describing it as long overdue.

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If you have any questions regarding the above information, please contact:
Jeffrey K. Shapiro (202) 737-9633 jshapiro@hpm.com