Source: https://www.regulations.gov/?_escaped_fragment_=documentDetail;D=FDA-2013-N-0125-0001
Timestamp: 2016-09-26 14:03:22
Document Index: 626941948

Matched Legal Cases: ['art 801', 'art 801', '§ 801', '§ 801', '§ 809', '§ 809', 'art 801', '§ 801', 'art 660', 'art 660', '§ 809', '§ 660', '§ 660', '§ 801', 'arts 660', 'arts 660', '§ 801', '§ 801', '§ 801', '§ 801', '§ 801', '§ 801', 'art 660', 'art 660', 'art 812', 'art 807', 'art 814', 'art 801', '§ 809', '§ 660', 'art 660', 'arts 660', 'art 660', '§ 660', '§ 660', '§ 610', '§ 809', '§ 610', '§ 660', '§ 610', '§ 809', '§ 610', '§ 660', '§ 660', '§ 660', '§ 610', '§ 809', '§ 610', '§ 660', '§ 660', '§ 610', '§ 809', '§ 610', 'art 801', '§ 801', '§ 801', '§ 801', '§ 801', 'art 809', '§ 809', '§ 809', '§ 809', '§ 809', 'art 812', '§ 812', '§ 809', 'arts 660']

Skip Navigation HomeHelpResourcesContact Us Advanced Search Start of Main Content Use of Certain Symbols in Labeling This Proposed Rule document was issued by the Food and Drug Administration (FDA) For related information, Open Docket Folder Show agency attachment(s) DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. FDA-2013-N-0125]
SummaryThe Food and Drug Administration (FDA) is proposing to revise medical device and biological product labeling regulations to explicitly allow for the inclusion of stand-alone graphical representations of information, or symbols, if the symbol has been established as part of a standard developed by a nationally or internationally recognized standards development organization (SDO) (referred to in this document as a “standardized symbol”) and such standardized symbol is part of a standard recognized by FDA for use on the labeling of medical devices (or on a subset of medical devices), provided that such symbol is explained in a symbols glossary that contemporaneously accompanies the medical device. FDA is also proposing to revise prescription device labeling regulations to authorize the use of the symbol statement “Rx only” on the labeling of prescription devices.
DatesSubmit electronic or written comments on the proposed rule by June 18, 2013. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by May 20, 2013, (see section VII). See section IX for the proposed effective date of a final rule based on the proposed rule in this document.
AddressesYou may submit comments, identified by Docket No. FDA-2013-N-0125 and/or Regulatory Information Number (RIN) 0910-AG74, by any of the following methods, except that comments on information collection issues under the PRA must be submitted to the Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) (see section VII).
Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.Written SubmissionsSubmit written submissions in the following way:
Mail/Hand delivery/Courier (for paper or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name, Docket No. FDA-2013-N-0125, and RIN 0910-AG74 for this rulemaking. All comments received may be posted without change to http://www.regulations.gov, including any personal information provided. For additional information on submitting comments, see section VIII.
For Further Information ContactMichael Ryan, Center for Devices and Radiological Health, Food and Drug Administration, 10903 NewHampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993, 301-796-6283; or
Supplementary InformationI. BackgroundMedical device labeling (1)
is intended to clearly communicate information to end users, including manufacturer identification, intended use, and directions for use. Section 502 of the FD&C Act (21 U.S.C. 352) requires that industry provide clear and understandable labeling for FDA-regulated products. A device is deemed misbranded, among other reasons, if its labeling is false or misleading (section 502(a)), if the required information on the labeling fails to appear in terms that are “likely to be read and understood by the ordinary individual under customary conditions of purchase and use” (section 502(c)), or if its labeling does not bear “adequate directions for use” (section 502(f) of the FD&C Act).
FDA has further defined labeling requirements for devices by regulation, requiring, in part 801 (21 CFR part 801), that “[a]ll words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language* * *” (§ 801.15(c)(1)). The regulation goes on to allow for use of foreign language under certain circumstances, but does not mention the use of graphics, pictures, or symbols to communicate information. Under the current regulation, graphics, pictures, or symbols in labeling that represent required information must be accompanied by explanatory English text adjacent to the symbol in order to “appear thereon in the English language.”
Under § 801.119, labeling for in vitro diagnostic (IVD) devices has adequate directions for use if it meets the requirements of § 809.10 (21 CFR 809.10), which prescribes the statements, declarations, and other information that IVD devices must display on their labeling. Although § 809.10 does not explicitly authorize the use of symbols, the Agency has interpreted this regulation generally to allow graphics, pictures, or symbols to meet the labeling requirements of this regulation except where this regulation specifies particular labeling language.
The FD&C Act also applies to biological products defined in section 351(i)(1) of the Public Health Service Act (PHS Act) (42 U.S.C 262(i). (2)
See, specifically, PHS Act section 351(j) (42 U.S.C. 262(j)). Accordingly, biological products that are also medical devices are subject to the labeling requirements of section 502 of the FD&C Act (applicable to any “word, statement or other information required by or under authority of [the FD&C] Act to appear on the label or labeling” of a medical device), as well as the regulations of part 801, including § 801.15. The part 660 (21 CFR part 660) labeling regulations applicable to certain biologic diagnostic substances for laboratory tests refer to the labeling requirements of § 809.10. See §§ 660.2 (for Antibody to Hepatitis B surface Antigen), 660.28 (for Blood Grouping Reagent), 660.35 (for Reagent Red Blood Cells), § 660.45 (for Hepatitis B Surface Antigen), and 660.55 (for Anti-Human Globulin).
The Food and Drug Administration Modernization Act (FDAMA) added section 514(c) to the FD&C Act (21 U.S.C. 360d(c)). This provision authorizes FDA to “recognize all or part of an appropriate standard established by a nationally or internationally recognized standard development organization,” for which a person may then submit a declaration of conformity in order to meet a premarket submission or other requirement under the FD&C Act when the standard applies to and satisfies the requirement, including a labeling requirement. Section 514(c)(2) of the FD&C Act also authorizes FDA to withdraw recognition of a standard through publication of a notice in theFederal Registerif FDA determines that the standard is no longer appropriate for meeting a device requirement under the FD&C Act. Congress noted with approval the past work of SDOs, such as the American National Standards Institute (ANSI), the International Organization for Standardization (ISO), and the International Electrotechnical Commission in the field of medical device products from “[l]ong before the enactment of the Medical Device Amendments of 1976” (S. Rep. No. 43, 105th Cong., 1st Sess. 23 (1997)).
Section 514(c) of the FD&C Act requires FDA to publish in theFederal Registerthe names of all standards to which recognition has been given. See the Center for Devices and Radiological Health's (CDRH's) public database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm for the most recent FDA listing of recognized consensus standards. In “Guidance for Industry and FDA Staff: CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standards for Recognition,” FDA set forth its procedures for recognition of consensus standards. This guidance is available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077322.pdf. Further information about the recognition of consensus standards can be found in FDA's “Guidance for Industry and FDA Staff: Frequently Asked Questions on Recognition of Consensus Standards,” available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm075064.pdf. FDA published the initial list of recognized consensus standards in theFederal Registerof February 25, 1998 (63 FR 9561).
Modifications to the initial and previous lists of recognized standards—announcing the addition, withdrawal, and revision of such standards—are published in theFederal Register.Changes in a recognized standard, including changes to a standardized symbol recognized in such standard, do not retroactively affect a product's clearance or approval status. The most recent modifications to the list of recognized standards, including a complete list of the 29 previous modifications, was published in theFederal Registeron January 15, 2013 (78 FR 2998). In addition, the Agency maintains hypertext markup language and portable document format (PDF) versions of the list of “FDA Recognized Consensus Standards.” Both versions are publicly accessible at the Agency's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. Interested persons should review the supplementary information sheet (SIS) published for the standard to understand fully the extent to which FDA recognizes the standard.
While section 503(b)(4) of the FD&C Act (21 U.S.C. 353(b)(4)) allows the labels of prescription drug products to contain the symbol statement “Rx only,” this provision is not applicable to prescription devices. In order to give manufacturers, repackers, relabelers, and distributors more labeling options for prescription devices, CDRH issued the guidance, “Alternative to Certain Prescription Device Labeling Requirements” on January 21, 2000, which is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085404.htm. It announced CDRH's intent to exercise enforcement discretion with respect to the use of the symbol statement “Rx only” on prescription medical device labeling as an alternative to the prescription use statement in § 801.109.II. Proposed Revision to Parts 660, 801, and 809FDA is proposing to revise parts 660, 801, and 809 to expressly allow for the use in medical device labeling of certain “stand-alone” symbols (not accompanied by explanatory text adjacent to the symbol) contained in a standard that FDA recognizes under its authority under section 514(c) of the FD&C Act, as long as a “symbols glossary” contemporaneously accompanies the device. The term “symbols glossary” means a compiled listing of each symbol used in the labeling of the device and of the meaning of or explanatory text for the symbol. As discussed previously, the current regulations do not mention the use of symbols. The medical device industry has requested permission to use stand-alone symbols in device labeling in order to make the label more user-friendly by replacing small, difficult-to-read text with pictorial information and to harmonize the labeling requirements of U.S. and foreign regulatory bodies.
Various symbols with accompanying text have been used in health product labeling for several years, both on package labels and within other labeling documents, such as the instructions for use. The proposed rule will continue to allow the use of symbols, including standardized symbols, on device labeling when the symbols are accompanied by explanatory adjacent text. For IVD devices intended for health professional use, CDRH and the Center for Biologics Evaluation and Research have interpreted applicable labeling requirements to allow the use of certain symbols contained in a standard recognized by FDA in labeling without explanatory text adjacent to the symbol. See FDA guidance entitled “Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use,” issued November 30, 2004. Additionally, CDRH has exercised enforcement discretion with respect to the prescription use symbol statement “Rx Only” (without accompanying explanatory text). See FDA guidance entitled “Alternative to Certain Prescription Device Labeling Requirements,” issued January 21, 2000, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072747.htm. In the international community, voluntary standards such as ISO 15223, originally published in 2000, have standardized, commonly-used symbols that are often used in U.S. device labeling with adjacent explanatory text, and in limited instances, without adjacent text for IVD devices.
On its own initiative and in response to requests received from the public, FDA expects to assess standardized symbols from time to time as part of itsconsensus standards recognition process. FDA will consider recognizing symbols contained in standards developed by SDOs that follow a process where the standard development 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.
It is important to note that any stand-alone symbol that conveys information that is required to appear on the labeling of a device would be subject to the requirements under the proposed amendment to § 801.15(c)(1) that the symbol would have to be recognized by FDA, used within any parameters of such recognition, and be explained in a symbols glossary that contemporaneously accompanies the device. Under section 502(f)(1) of the FD&C Act, device labeling is required to provide adequate directions for use to the user of a device. See §§ 801.5 and 801.109. Therefore, any stand-alone symbol on the labeling of a device that conveys directions for use would be subject to the symbols glossary requirements under the proposed amendment to § 801.15(c)(1).
FDA is proposing to revise § 801.109(b)(1), as well as § 801.15(c)(1), to include language that affirmatively permits use of the symbol statement “Rx only,” without accompanying explanatory text, as an alternative to the prescription device label statement “Caution: Federal law restricts this device to sale by or on the order of a (licensed healthcare practitioner).” It is important to note that the word “only” needs to immediately follow the symbol “Rx.” However, the symbol statement “Rx only” does not necessarily need to be bracketed in quotation marks, and the word “only” may appear in upper or lower case letters, for example, Rx only, Rx Only, or Rx ONLY. As in the case of labels for prescription drugs, the new label statement for prescription medical devices may be printed as either “Rx only” or “℞ only.” (See 67 FR 4904; February 1, 2002.) The ℞ symbol in the symbol statement “Rx only” or the symbol statement “Rx only” in its entirety may be printed in bold or in regular type.
The proposed amendments to §§ 801.15 and 809.10 would also cover biological products regulated as devices. This rule also proposes to amend the specific labeling requirements applicable to biological products in part 660 to allow for the labeling use of standardized symbols that FDA recognizes under its authority under section 514(c) of the FD&C Act, as long as there is a “symbols glossary” in the labeling that contemporaneously accompanies the product. We have also proposed changes in part 660 to describe more uniformly the labeling requirements applicable to licensed products subject to this part: diagnostic substances for laboratory tests.III. Environmental ImpactThe Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.IV. Legal Authority for the Proposed RuleSection 514(c)(1)(A) of the FD&C Act authorizes FDA to recognize, by publication in theFederal Register, “all or part of an appropriate standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet a premarket submission requirement or other requirement under the FD&C Act to which such standard is applicable.” Section 514(c)(2) of the FD&C Act allows FDA to withdraw recognition of a standard through publication of a notice in theFederal Registerif FDA determines that the standard is no longer appropriate for meeting a device requirement under the FD&C Act. In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) authorizes the Agency to issue regulations for the efficient enforcement of the FD&C Act.
Under section 201(m) of the FD&C Act (21 U.S.C. 321(m)), the term “labeling” means all labels and other written, printed, or graphic matter: (1) Upon any article or any of its containers or wrappers or (2) accompanying such article. Under section 201(k) of the FD&C Act, the term “label” means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of [the FD&C Act] that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.V. Analysis of ImpactsFDA has examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a writtenstatement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $139 million, using the most current (2011) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.
The full discussion of the economic impacts (Ref. 1) is available in docket FDA-2013-N-0125 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm. VI. FederalismFDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the proposed rule, if finalized, would not contain policies that would have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency tentatively concludes that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.VII. Paperwork Reduction Act of 1995This proposed rule contains information collection provisions that are subject to review by the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A description of these provisions is given in the Description section of this document with an estimate of the annual third-party disclosure burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.
Table 1—Estimated Annual Reporting Burden 1 ActivityNumber ofrespondentsAnnualfrequency perresponseTotal annual responsesHours perresponseTotal hours
Glossary3,00013,00013,000
Table 2—Third Party Disclosure Burden 1 ActivityNumber ofrespondentsAnnualfrequency perresponseTotal annual responsesHours perresponseTotal hours
Glossary3,00013,000412,000
In addition to the proposed third-party disclosure requirements referenced previously, this proposed rule refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subpart B have been approved under OMB control number 0910-0231; the collections of information under part 801 and § 809.10 have been approved under OMB control number 0910-0485; and the collections of information in §§ 660.2, 660.28, 660.35, 660.45, and 660.55 have been approved under OMB control number 0910-0338.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3407(d)), the Agency has submitted the information collection provisions of this proposed rule to OMB for review. These requirements will not be effective until FDA obtains OMB approval. FDA will publish a notice concerning OMB approval of these requirements in theFederal Register.VIII. CommentsInterested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (seeADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. IX. Proposed Effective DateFDA is proposing that any final rule based on this proposal become effective 90 days after the date of its publication in theFederal Registeror at a later date if stated in the final rule.X. ReferenceThe following reference has been placed on display in the Division of Dockets Management (seeADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday, and is available electronically at http://www.regulations.gov. 1. Use of Symbols in Medical Device Labeling: Preliminary Regulatory Impact Analysis; Initial Regulatory Flexibility Analysis; Unfunded Mandates Reform Act Analysis.
List of Subjects21 CFR Part 660
Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq., as amended), the Public Health Service Act, and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR parts 660, 801, and 809 be amended as follows:Part 660 Additional Standards for Diagnostic Substances for Laboratory Tests
Authority21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372; 42 U.S.C. 216, 262, 263, 263a, 264.
2. Amend § 660.2 by revising paragraph (c) introductory text to read as follows:
§ 660.2
(c) Labeling. In addition to the applicable labeling requirements of §§ 610.62 through 610.65 and § 809.10 of this chapter, and in lieu of the requirements in §§ 610.60 and 610.61 of this chapter, the following information shall be included. The applicant may provide the labeling information referenced in this subsection in the form of a symbol, provided that such symbol is either accompanied by explanatory text adjacent to the symbol or is contained in a standard that FDA recognizes under its authority under section 514(c) of the Federal Food, Drug, and Cosmetic Act and is explained in a symbols glossary that contemporaneously accompanies the biological product. The term “symbols glossary” means a compiled listing of each symbol used in the labeling of the biological product and of the meaning of or explanatory text for the symbol.
3. Amend § 660.28 by revising the introductory text to read as follows:
In addition to the applicable labeling requirements of §§ 610.62 through 610.65 and § 809.10 of this chapter, and in lieu of the requirements in §§ 610.60 and 610.61 of this chapter, the following requirements shall be met. The applicant may provide the labeling information referenced in this section in the form of a symbol, provided that such symbol is either accompanied by explanatory text adjacent to the symbol or is contained in a standard that FDA recognizes under its authority under section 514(c) of the Federal Food, Drug, and Cosmetic Act and is explained in a symbols glossary that contemporaneously accompanies the biological product. The term “symbols glossary” means a compiled listing of each symbol used in the labeling of the biological product and of the meaning of or explanatory text for the symbol.
4. Amend § 660.35 by revising the introductory text to read as follows:
§ 660.35
5. Amend § 660.45 by revising the introductory text to read as follows:
In addition to the applicable labeling requirements of §§ 610.62 through 610.65 and § 809.10 of this chapter, and in lieu of the requirements in §§ 610.60 and 610.61 of this chapter, the following information shall be included. The applicant may provide the labeling information referenced in this section in the form of a symbol, provided that such symbol is either accompanied by explanatory text adjacent to the symbol or is contained in a standard that FDA recognizes under its authority under section 514(c) of the Federal Food, Drug, and Cosmetic Act and is explained in a symbols glossary that contemporaneously accompanies the biological product. The term “symbols glossary” means a compiled listing of each symbol used in the labeling of the biological product and of the meaning of or explanatory text for the symbol.
6. Amend § 660.55 by revising the introductory text to read as follows:
§ 660.55
In addition to the applicable labeling requirements of §§ 610.62 through 610.65 and § 809.10 of this chapter, and in lieu of the requirements in §§ 610.60 and 610.61 of this chapter, the following requirements shall be met, The applicant may provide the labeling information referenced in this section in the form of a symbol, provided that such symbol is either accompanied by explanatory text adjacent to the symbol or is contained in a standard that FDA recognizes under its authority under section 514(c) of the Federal Food, Drug, and Cosmetic Act and is explained in a symbols glossary that contemporaneously accompanies the biological product. The term “symbols glossary” means a compiled listing of each symbol used in the labeling of the biological product and of the meaning of or explanatory text for the symbol.
* * * * *Part 801 Labeling
Authority21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.
8. Amend § 801.15 by revising the section heading and paragraph (c)(1) to read as follows:
(v) The symbol statement “Rx only” or “℞ only” may be used as provided under § 801.109(b)(1).
9. Amend § 801.109 by revising paragraph (b)(1) to read as follows:
§ 801.109
* * * * *Part 809 in Vitro Diagnostic Products for Human Use
Authority21 U.S.C. 331, 351, 352, 355, 360b, 360c, 360d, 360h, 360i, 360j, 371, 372, 374, 381.
11. Amend § 809.3 by adding paragraph (c) to read as follows:
§ 809.3
12. Amend § 809.10 by revising the paragraph (a) introductory text, the first sentence in paragraph (b), and paragraphs (c)(2) introductory text, (d) introductory text, (e)(1) introductory text, and (f) introductory text to read as follows:
§ 809.10
(2) In the case of a shipment or delivery for an investigation that is not subject to part 812 (see § 812.2(c)), if the following conditions are met, including that, where information required by those conditions is provided in the form of a symbol, such symbol must either be accompanied by explanatory text adjacent to the symbol or contained in a standard that FDA recognizes under its authority under section 514(c) of the Federal Food, Drug, and Cosmetic Act, and explained in a symbols glossary that contemporaneously accompanies the in vitro diagnostic product:
(d) The labeling of general purpose laboratory reagents (e.g., hydrochloric acid) and equipment (e.g., test tubes and pipettes) whose uses are generally known by persons trained in their use need not bear the directions for use required by § 809.10(a) and (b), if their labeling meets the requirements of this paragraph, except where such information is provided in the form of a symbol, provided that such symbol is either accompanied by explanatory text adjacent to the symbol or is contained in a standard that FDA recognizes under its authority under section 514(c) of the Federal Food, Drug, and Cosmetic Act and is explained in a symbols glossary that contemporaneously accompanies the reagent or equipment.
[FR Doc. 2013-09175 Filed 4-18-13; 8:45 am]BILLING CODE 4160-01-PFootnotes
Under section 201(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(m)), the term “labeling” means all labels and other written, printed, or graphic matter: (1) Upon any article or any of its containers or wrappers or (2) accompanying such article. Under section 201(k) of the FD&C Act, the term “label” means a display of written, printed, or graphic matter upon the immediate container of any article; and a requirement made by or under authority of the FD&C Act that any word, statement, or other information appear on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or is easily legible through the outside container or wrapper.
“The term `biological product' means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.” (42 U.S.C 262(i))
Attachments View All (1) Return to top Reference 1 Use of Symbols in Medical Device Labeling Preliminary Regulatory Impact Analysis; Initial Regulatory Flexibility... View Attachment: + View more information View document: No documents available. Attachments View All (0) Comment Now! Comment Period Closed Jun 18 2013, at 11:59 PM ET ID: FDA-2013-N-0125-0001 Tracking Number: View original printed format: Document Information Date Posted: Apr 19, 2013RIN: 0910-AG51CFR: 21 CFR Parts 660, 801, and 809Federal Register Number: 2013-09175 Show More Details Submitter Information Comments16 Comments Received* Attached is a comment letter on behalf of Welch Allyn. View Comment Please see attached comments. View Comment See attached file(s) View Comment Docket Information This document is contained in FDA-2013-N-0125 Related Dockets: NoneRelated RINs: NoneRelated Documents: Use of Symbols in Labeling Related Comments: View all * This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document. Document text and images courtesy of the Federal Register Home Search Advanced Search Browse By Category Learn About Us eRulemaking Program Media Toolkit Agencies Awards & Recognition Enhancements & Fixes Resources Site Data Regulatory Agenda Agency Reports Required by Statute API Overview Developers Help How to use Regulations.gov FAQs Glossary Connect With Contact Us Privacy and Security Notice User Notice Accessibility Statement Partner Sites We the People Federal Register Reginfo Congress.gov USA.gov E-Gov Opengov Participate Today!