Medical Devices

Labeling Requirements - Other Labeling Exemptions

Other Exemptions

Exemptions from Packaging and Labeling Requirements 21 CFR 801.150

  • In-process devices that are being transported (in transit) from one manufacturing site to another are exempt if:
    • The person who introduced the product into commerce is the operator of the firm where the device is to be further processed.
    • The person introducing the product into commerce is not the operator, and the delivery is to be made under a written agreement which includes the names and addresses of the firms and listing those specifications necessary for further processing.
    • The shipments are unsterile devices, are labeled as sterile, are in transit to a contract sterilizer [21 CFR 801.150(e)], and are exempt only if both of the following are met:
      1. There is in effect a written agreement between the two parties containing:
        1. names and addresses of both parties which is signed by both the person authorizing the shipment and the person in charge of the sterilization facility;
        2. instructions for maintaining records to insure total accountability;
        3. acknowledgment that the devices are nonsterile and being shipped for further processing;
        4. a statement detailing the sterilization process, sterilant media, equipment, and quality assurance controls to be used; and
      2. Each pallet, carton, or other designated unit is conspicuously market to indicate its nonsterile nature.

    This exemption is void if the product is adulterated or misbranded, or if a copy of the agreement is not available for FDA inspection.

 

Page Last Updated: 06/30/2014
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