Investigational Devices: Supply Management
FDA regulation 21 CFR 812.43(b) stipulate that investigational devices can only be shipped to qualified investigators who are documented as participating in the investigation.
FDA regulation 21 CRF 812.140(b)(2) requires accurate, complete, and current records relating the investigation including:
Records of shipment and disposition. Records of shipment shall include the name and address of the consignee, type and quantity of device, date of shipment, and batch number or code mark. Records of disposition shall describe the batch number or code marks of any devices returned to the sponsor, repaired, or disposed of in other ways by the investigator or another person, and the reasons for and method of disposal.
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