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Labeling Requirements - In Vitro Diagnostic Devices

• Introduction
  
• Label Requirements for the Immediate Container
  
• Labeling Requirements for Inserts and Outer packaging
  
• Exemptions from Labeling Requirements
  
• Labeling for General Purpose Reagents and Equipment
   
  • Specific labeling requirements for analyte specific reagents
  • Restrictions on sale distribution and use of analyte specific reagents
  • Specific labeling requirements for OTC test sample collection systems
  • Restrictions on the sale, distribution and use of OTC test sample collection systems

Introduction

In vitro diagnostic products (IVD's) are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Such products are intended for use in the collection, preparation, and examination of specimens taken from the human body. In vitro diagnostic (IVD) labeling requirements are located in 21 CFR Part 809. Numbers appearing in parentheses next to subject headings are the corresponding sections of 21 CFR. This section contains the basis requirements for label and labeling (package insert) as specified in the labeling regulations for in vitro diagnostic products.

Label Requirements for the Immediate Container [21 CFR 809.10(a)]

The label for IVD's must state the following information, except in cases where it is not applicable. In addition, all information must appear on the outside container or wrapper, or be easily legible through the outside container or wrapper.

If the presence of any label information will interfere with the test, the information may appear on the outside wrapper or container instead of the label.

If the immediate containers are too small, or otherwise unable to bear labels with sufficient space, then the required labeling as listed below annotated with an asterisk (*) may appear on the outer container labeling only.

Label requirements are as follows:

• The established and proprietary names of the product, e.g., cholesterol meters;
• * The intended use or uses, e.g., pregnancy detection, diabetes screening, etc.;
• A statement of warnings or precautions for users listed in 16 CFR part 1500 (hazardous substances) and any other warnings appropriate to user hazards, and a statement "For In Vitro Diagnostic Use;"
• Name and place of business of the manufacturer, packer, or distributor;
• Lot or control number traceable to the production history
  • - Multiple unit products must have traceability of the individual units;
    
  • - Instrument lot numbers must allow for traceability of subassemblies; and
    
  • - A multiple unit product that requires use of its components as a system should have the same lot number, or other suitable uniform identification, on all units.
    
• * For Reagents:
  • - Established (common or usual) name;
    
  • - Quantity, proportion, or concentration of all active ingredients; e.g., mg., weight per unit volume, mg./dl etc., and for reagents derived from biological materials the source and measure of its activity, e.g., bovine, I.U., etc.;
    
  • - Storage instructions adequate to protect the stability of the product, i.e., temperature, humidity, etc.;
    
  • - Instructions for manipulation of products requiring mixing or reconstitution, along with instructions for        storage of products that have been reconstituted or mixed;
    
  • - Means to assure that the product meets appropriate standards of purity, quality, etc., at the time of use, including one or more of the following:
    
    • i. expiration date (date beyond which the product is not to be used);
      
    • * ii. statement of any visual indication of alteration;
    • * iii. Instructions for a simple check to assure product usefulness;
  • * - The net quantity of contents.

Labeling Requirements for Inserts and Outer Packaging 21 CFR 809.10(b)

Labeling must contain in one place the following information in the FORMAT and ORDER listed below, except where information is not applicable, or as specified in a standard for a particular product class.

If the device is a reagent intended as a replacement in a diagnostic system, labeling may be limited to that information necessary to adequately identify the reagent and to describe its use in the system.

If the device is a multiple purpose instrument used for diagnostic purposes, and not committed to specific diagnostic procedures or systems, labeling can be restricted to those points annotated by an asterisk (*).

• * The proprietary and established product name;
• * The intended use of the product and whether it is a qualitative or quantitative type of procedure, e.g., screening, physician's office, home use, etc.;
• Summary and explanation of the test, including a short history containing methodology and the special merits and limitations of the test;
• The chemical, physical, physiological, or biological principles of the procedure.
• For Reagents:
  • - The common name, if any, and quantity, proportion, or concentration or each reactive ingredient; and for biological material, the source and measure it its activity;
    
  • - Appropriate cautions or warnings listed in 16 CFR Part 1500; the statement: "For In Vitro Diagnostic Use;" and any other limiting statements appropriate to the intended use of the product;
    
  • - Adequate directions for reconstitution, mixing, dilution, etc.;
    
  • - Appropriate storage instructions;
    
  • - A statement of purification or treatment required for use; and
    
  • - Physical, biological, or chemical indications of instability or deterioration.
    
• * For Instruments:
  • - Use or function;
  • - Installation procedures and requirements;
  • - Principles of operation;
  • - Performance characteristics and specifications;
  • - Operating instructions;
  • - Calibration procedures, including equipment and/or materials;
  • - Operational precautions and limitations;
  • - Hazards; and
  • - Service and maintenance information
    
• Specimen collection and preparation for analysis, describing;
  • - Special precautions/preparations;
  • - Additives necessary to maintain specimen integrity;
  • - Known interfering substances; and
  • - Recommended specimen storage, handling, and shipping instructions.
• A step by step outline of recommended procedures from the reception of the specimen to the obtaining of results. In addition to the following, this should include a list of any points that might improve precision or accuracy:
  • - A list of materials provided and instruction for use, e.g., reagents, equipment, etc.;
    
  • - A list of necessary materials that are not provided (include details such as sizes, numbers, types, and quality);
    
  • - A description of the amounts of reagents necessary, and parameters such as time, temperature etc.;
    
  • - A statement related to final reaction stability and any time restrictions on accurate measurements;
    
  • - Details of calibration, identifying and listing and necessary preparation of the reference materials, samples, and blanks. Describe the calibration range including the highest and lowest values measured; and
    
  • - Details of necessary quality control procedures and materials, e.g., positive and negative controls, acceptable performance limits.
• Explanation of the procedure for calculating the unknown, including the definition of each component of the formula, a sample calculation, and the number of significant figures appropriate for the answer;
• Limitations of the procedure, e.g., identify situations which will have an adverse impact on test results. If further testing either more specific or more sensitive, is indicated in all cases where certain results are obtained, the need for the additional test shall be stated;
• Expected values including how the range(s) was established and identify the populations on which it was established;
• Specific performance characteristics as appropriate including accuracy, specificity, precision, and sensitivity;
• * Bibliography;
• * Name and place of business of the manufacturer, packer, or distributor; and
• * Date of issuance of the last labeling revision by the firm.

Exemptions from Labeling Requirements

Shipments or other deliveries of IVD devices are exempt from label and labeling requirements in the above headings and from standards listed under Part 861 provided the following conditions are met:

• A shipment or delivery for an investigation subject to Part 812, Investigational Device Exemption (IDE), if the device is in compliance with the subject IDE; or

• A shipment or delivery for an investigation that is not in compliance with Part 812 (most IVD's are exempt from the IDE because of the following labeling) if the following conditions are met
  • - A product in the laboratory research phase, not represented as an IVD, that is prominently labeled: "For Research Use Only. Not for use in diagnostic procedures;" and
    
  • - A product that is being shipped or delivered for product testing prior to full commercial marketing that is prominently labeled: "For Investigational Use Only. The performance characteristics of this product have not been established."

Labeling of General Purpose Reagents and Equipment

General purpose items include routine laboratory reagents such as hydrochloric acid and equipment such as glassware whose uses are generally known by persons trained in their use. They do not need to bear the directions for use listed under Label Requirements for the Immediate Container and Labeling Requirements for Inserts and Outer Packaging, if their labeling meets the requirements listed below. If the product packaging is too small to accommodate a label with sufficient space for the labeling, and if the product is packaged in an outer container which has all of following on its labeling, then only those portions annotated with an asterisk (*) must be on the product label.

• Reagents:
  • * - A declaration of the established name, if any, and quantity, proportion, or concentration of the reagent ingredient stated in a system generally recognized by the user;
    
  • - A statement of the purity and quality including a qualitative statement of any impurities. This can be satisfied by using a statement of conformity with a generally recognized and available standard;
    
  • - A statement of warnings or precautions for users as contained in the regulations in 16 CFR Part 1500 and any other appropriate warnings, and the statement: "For Laboratory Use;"
    
  • - Net quantity of contents in terms of weight or volume, or numerical count, or any combination thereof;
    
  • - Appropriate storage instructions;
    
  • * - Name and place of business of the manufacturer, packer, or distributor;
    
  • * - A lot or control number traceable to the manufacturing history of the product; and.
    
  • - A statement indicating the presence of and characterizing any catalytic or nonreactive ingredients e.g., buffers, preservatives, stabilizers.

• Equipment
  • - Product labeling need include only a statement adequately describing the product, its composition, and physical characteristics if necessary for its proper use.

Information on other labeling Issues

Updated July 21, 2000

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