§ 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: ( 1 ) The failure of such word, statement, or information to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase;
( 2 ) The failure of such word, statement, or information to appear on two or more parts or panels of the label, each of which has sufficient space therefor, and each of which is so designed as to render it likely to be, under customary conditions of purchase, the part or panel displayed;
( 3 ) The failure of the label to extend over the area of the container or package available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or information;
( 4 ) Insufficiency of label space for the prominent placing of such word, statement, or information, resulting from the use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label;
( 5 ) Insufficiency of label space for the placing of such word, statement, or information, resulting from the use of label space to give materially greater conspicuousness to any other word, statement, or information, or to any design or device; or
( 6 ) Smallness or style of type in which such word, statement, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding with other written, printed, or graphic matter.
( b ) No exemption depending on insufficiency of label space, as prescribed in regulations promulgated under section 502(b) of the act, shall apply if such insufficiency is caused by: ( 1 ) The use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label;
( 2 ) The use of label space to give greater conspicuousness to any word, statement, or other information than is required by section 502(c) of the act; or
( 3 ) The use of label space for any representation in a foreign language.
( c ) ( 1 ) ( i ) All words, statements, and other information required by or under authority of the act to appear on the label or labeling for a device shall appear thereon in one or more of the following formats: ( A ) The English language;
( B ) In the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English;
( C ) A symbol accompanied by adjacent explanatory English text, or text in the predominant language of the Territory, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English;
( D ) A symbol not accompanied by adjacent explanatory text that: ( 1 ) Is contained in a standard that FDA recognizes under its authority in section 514(c) of the act;
( 2 ) Is used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition; and
( 3 ) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used;
( E ) A symbol not accompanied by adjacent explanatory text that: ( 1 ) Is established in a standard developed by a standards development organization (SDO);
( 2 ) Is not contained in a standard that is recognized by FDA under its authority in section 514(c) of the act or is contained in a standard that is recognized by FDA but is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition;
( 3 ) Is determined by the manufacturer to be likely to be read and understood by the ordinary individual under customary conditions of purchase and use in compliance with section 502(c) of the act;
( 4 ) Is used according to the specifications for use of the symbol set forth in the SDO-developed standard; and
( 5 ) Is explained in a paper or electronic symbols glossary that is included in the labeling for the device and the labeling on or within the package containing the device bears a prominent and conspicuous statement identifying the location of the symbols glossary that is written in English or, in the case of articles distributed solely in Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be used;
( F ) The symbol statement “Rx only” or “℞ only” may be used as provided under § 801.109(b)(1).
( ii ) The use of symbols in device labeling which do not meet the requirements of paragraph (c)(1)(i) of this section renders a device misbranded under section 502(c) of the act.
( iii ) For purposes of paragraph (c)(1)(i) of this section: ( A ) An SDO is an organization that is nationally or internationally recognized and that follows a process for standard development that is transparent, (*i.e.,* open to public scrutiny), where the participation is balanced, where an appeals process is included, where the standard is not in conflict with any statute, regulation, or policy under which FDA operates, and where the standard is national or international in scope.
( B ) The term “symbols glossary” means a compiled listing of: ( 1 ) Each SDO-established symbol used in the labeling for the device;
( 2 ) The title and designation number of the SDO-developed standard containing the symbol;
( 3 ) The title of the symbol and its reference number, if any, in the standard; and
( 4 ) The meaning or explanatory text for the symbol as provided in the FDA recognition or, if FDA has not recognized the standard or portion of the standard in which the symbol is located or the symbol is not used according to the specifications for use of the symbol set forth in FDA's section 514(c) recognition, the explanatory text as provided in the standard.
( 2 ) If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language.
( 3 ) If the labeling contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear on the labeling in the foreign language.
[41 FR 6896, Feb. 13, 1976, as amended at 81 FR 38930, June 15, 2016]