Unpacking Averages: Device Manufacturers Should Use the Newly Released Demographic Data in MDRs to Ensure Their Devices Are Not Disproportionately Hurting Minorities

As you may know, we have been submitting FOIA requests asking FDA to share data from its various programs.  In October, FDA granted our April FOIA request in which we asked the agency to add back demographic data fields that it had previously removed from its public Medical Device Report (“MDRs”) databases. To find potential bias, we encourage manufacturers to use this data to look for any disproportionate impact its devices are having on minorities….
By: Epstein Becker & Green