Manufacturers must submit death, serious injury, and malfunction reports within 30 days after they become aware of a reportable event. The information can come from any source. If a firm cannot provide complete information, it must provide a statement explaining why such information was incomplete and the steps taken to obtain the information. Any required information not available at the time of the report, obtained at a later date, must be forwarded to FDA in a supplemental report within 1 month of receipt.
Manufacturers are responsible for investigating and evaluating the cause of each event.
These investigations must follow the requirements in 820.198 and provide the information required on form FDA 3500A, Block H.6, H.7, and H.9. They become aware that an MDR reportable event, from any source, requires remedial action to prevent an unreasonable risk of substantial harm to the public health. They receive an FDA written request for the submission of five-day reports. This requirement no longer exists. Therefore, the submission of an event by a health care professional does not require the manufacturer to report the event based solely on the statements of a health care professional.