Natus Europe GmbH – FDA Warning Letter, Nov 15, 2012

An FDA inspection of Natus Europe GmbH in Planegg, Germany, from November 12-15, 2012, revealed that their Echo-Screen devices are misbranded under section 502(t)(2) of the Act due to failure to furnish required information under section 519 and 21 CFR Part 803 (Medical Device Reporting - MDR).

The firm failed to develop, maintain, and implement written MDR procedures (21 CFR 803.17). Their "Vigilance and Recall procedure" did not address FDA reporting. A new "Adverse Event Reporting Procedure" (QMS-000039, Rev E) lacked an effective date, omitted definitions for "reasonably known" and "reasonably suggests," and failed to provide instructions for FDA 3500A form completion, supplemental report requirements, and the correct submission address, while still referencing obsolete baseline reports. The firm's response regarding MDR procedures was deemed inadequate.

Additionally, the inspection identified quality system deficiencies under 21 CFR Part 820 (Quality System regulation): - Failure to establish and maintain adequate CAPA procedures (21 CFR 820.100(a)). While a new procedure was adopted, systemic corrective action, including retroactive review of CAPA reports, was not provided. - Failure to establish and maintain adequate complaint handling procedures to evaluate MDR reportability (2