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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals

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.

Information on other Labeling Issues

Updated 4/17/1998

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