FDA Announces Approval of Medical Device Adverse Event Program Under Paperwork Reduction Act

Summary

The Food and Drug Administration (FDA) has announced that it has received approval from the Office of Management and Budget (OMB) for a collection of information related to the Adverse Event Program for Medical Devices, as part of the Paperwork Reduction Act of 1995, which is administered by the FDA through the Medical Product Safety Network (MedSun)