FDA Cites Minnesota Devicemaker for Design Controls

October 3, 2019

The FDA hit Vasamed for design control procedures and other deficiencies at its Eden Prairie, Minnesota facility.

The hemodynamic devicemaker failed to specifically define “design change” in its design controls procedure, the agency said.

In addition, the agency flagged problems with a circuit board revision history for the firm’s PAD-IQ, a peripheral vascular assessment device.

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