Colorado Devicemaker Cited for Lack of Acceptance Criteria

The FDA slapped Arvada-based manufacturer Newman Medical with a Form 483 for failing to define certain acceptance criteria for its DigiDop device.

The agency noted during its May 28-31 inspection that the firm didn’t define maximum total output power acceptance criteria for its Class II DigiDop continuous wave Doppler probes, devices used to listen to fetal heartbeats during pregnancy.

The investigator said that the firm had different documents specifying different maximum values, and no documentation defining the actual acceptance criteria.