Reports of race, ethnicity, or skin tone occurred 320 times in 12.5% of 767 FDA summary documents that discussed pulse oximeter performance testing from 1996 to 2024, reported Kadija Ferryman, PhD, of ...

There was "low but improving uptake" of reporting about the diversity of participants in summary documents for FDA-cleared pulse oximeters after voluntary guidance was issued in 2013, an analysis of ...