FDA Finds Flaws with Georgia Devicemaker’s MDR Procedures
The FDA cited Enuresis Solutions for its written medical device reporting (MDR) procedures and design controls, which were found wanting during its Feb. 25–26 inspection.
The Savannah, Georgia company was scolded for having a deficient MDR procedure. For example, the firm’s written procedure did not require determining what type of report to submit (five or 30-day) and submitting adverse events in a determined timeframe.
The firm also lacked established design control procedures and didn’t provide records for the design of its DryBuddy bedwetting alarm product line.