Baseline and Annual Reports

Manufacturers are required to submit a baseline report (FDA Form 3417) to the FDA with the initial event report (Form 3500A). These reports help track the frequency of reportable events tied to specific devices and product families.23 Manufacturers usually report a summary of complaints in annual PMA reports, although they are not required to by regulation.24 If a manufacturer obtains information that was not provided in a report to the FDA because it was not known or available at the time of the initial report, the manufacturer must submit a supplemental report within 1 month of the receipt of this informa-tion.25

User facilities are required to submit annual reports on FDA Form 3419, including information for each reportable event that occurred during the annual reporting period.26

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