Written MDR Procedure Lands Miramar Labs a Form 483

Miramar Labs’ Inc. received a Form 483 after an inspection revealed defects in its medical device reporting (MDR) procedures and other issues.

When Miramar’s Santa Clara, Calif., facility was inspected from July 25 to Aug. 1, investigators discovered that the company’s written MDR procedure did not include a way to ensure timely and effective identification, communication, and evaluation of events that might have required reporting.

In particular, the MDR procedure did not have instructions to file MDRs for overseas incidents reported to foreign authorities for devices also marketed in the US. For example, the company filed a report in Belgium related to a patient complaint about its sweat-reduction microwave treatment miraDry, but did not file an MDR for this incident in the US where the product is also sold. — Jeff Kinney