• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-
New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR801.61]
See Related Information on Statement of identity. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 801 -- LABELING

Subpart C--Labeling Requirements for Over-the-Counter Devices

Sec. 801.61 Statement of identity.

(a) The principal display panel of an over-the-counter device in package form shall bear as one of its principal features a statement of the identity of the commodity.

(b) Such statement of identity shall be in terms of the common name of the device followed by an accurate statement of the principal intended action(s) of the device. Such statement shall be placed in direct conjunction with the most prominent display of the name and shall employ terms descriptive of the principal intended action(s). The indications for use shall be included in the directions for use of the device, as required by section 502(f)(1) of the act and by the regulations in this part.

(c) The statement of identity shall be presented in bold face type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed.

-
-