What general labeling requirements are necessary?

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The criteria in section 812.2(c)(3) include compliance with labeling requirements in section CFR 809.10(c), which exempts shipments and other deliveries of IVDs from certain labeling requirements.

These exemptions apply if either condition is met:

(1) The device complies with part 812, or

(2) The investigation is not subject to part 812 and one of the following conditions is met:

  • For a product in the laboratory research phase of development, and not represented as an effective in vitro diagnostic product, all labeling bears the statement, prominently placed: "For Research Use Only. Not for use in diagnostic procedures.''
  • For a product being shipped or delivered for product testing prior to full commercial marketing (for example, for use on specimens derived from humans to compare the usefulness of the product with other products or procedures which are in current use or recognized as useful), all labeling bears the statement, prominently placed: "For Investigational Use Only. The performance characteristics of this product have not been established.''

About the Author
Proxima CRO Team
Joel Reid
Regulatory Affairs Associate

Joel has a Bachelors Degree in Psychology and German. He also has undergraduate research experience in neuroimaging at the Waco VA.

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