CPG Sec. 300.300 Ineffective Devices - 502(f)(I) Labeling Requirements

Description

It is our concept of section 502(f)(l) *of the Federal Food, Drug, and Cosmetic Act (the Act)* and the pertinent regulations that an ineffective device cannot be brought into compliance with that section. *21 CFR* 80l.5 defines "adequate directions for use" as meaning directions under which the layman could use a device for the purposes for which it is intended. This wording implies that the directions for use must be such as to enable the user to employ the article successfully for the intended purpose. Obviously, it is not possible to prepare directions that would enable the layman to use a device which is not effective for any medical purpose.

Scope & Applicability

• 21CFR801.15§ 801.15 Medical devices; prominence of required label statements; use of symbols in labeling.

  (a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502(c) of the act by reason, among other reasons, of:Read full regulation →

• 21CFR801.5§ 801.5 Medical devices; adequate directions for use.

  Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specificatiRead full regulation →

• 21CFR1040.20§ 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.

  (a) Applicability.Read full regulation →

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