Medical Device Act. If any of the Products are medical devices, Buyer acknowledges that it is familiar with the Safe Medical Devices Act of 1990 ("Devices Act") and the reporting obligations imposed on device users thereunder. In this regard, Xxxxx agrees to notify ZEISS within 10 days of the occurrence of any event identified in the Devices Act imposing a reporting obligation on Buyer and/or ZEISS (except for events representing an imminent hazard that require notification to the United States Food and Drug Administration ("FDA") within 72 hours, in which case, such notice will be delivered to ZEISS immediately. Buyer shall maintain adequate tracking for the Products to enable ZEISS to meet the FDA requirements applicable to the tracking of medical devices.
Medical Device Act. If any of the Products are medical devices, Buyer acknowledges that it is familiar with the Safe Medical Devices Act of 1990 ("Devices Act") and the reporting obligations imposed on device users thereunder. In this regard, Xxxxx agrees to notify ZEISS within 10 days of the occurrence of any event identified in the Devices Act imposing a reporting obligation on Buyer and/or ZEISS (except for events representing an imminent hazard that require notification to the United States Food and Drug Administration ("FDA") within 72 hours, in which case, such notice will be
