User Error, Other Provisions of Reporting Guidance Draw Praise

Final FDA guidance updating device reporting requirements clarifies the obligations of contract manufacturers and makes other welcome changes to the March 2013 draft version.

The final guidance provides new recommendations on reporting adverse events, requesting reporting exemptions, submitting five-day reports, and reporting remedial actions.

Under the draft guidance, both contract manufacturers and specification developers for a given device must comply with MDR reporting obligations. The final guidance states that a contract manufacturer only needs to comply with reporting requirements if it also distributes or markets the device.  — Jeff Kinney