FDA WARNING_LETTER - Acclarent, Inc. - February 24, 2012

On June 14, 2012, the FDA issued a Warning Letter to Acclarent, Inc. following an inspection from December 20, 2011, to February 24, 2012. The inspection found that Acclarent's ear, nose, and throat devices, including the Inspira AIR Balloon Dilation System and Cyclops Multi-angle Endoscope, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations included: 1. **Failure to ensure devices conform to user needs and intended uses, and inadequate risk analysis (21 CFR 820.30(g))**: Design validation for the Inspira AIR Balloon Catheter and Stylet using a simulated airway model did not address treated medical conditions (e.g., subglottis stenosis), variety of human anatomy sizes (including children/infants), clinical deflation environment, or stylet effects on deflation time. Additionally, risk analysis documents did not account for potential risks when using Inspira AIR devices on children and premature infants, despite no age restriction for use. Acclarent's March 15, 2012, response was deemed inadequate as it lacked revised documents, evidence of implementation, training, or systemic corrective action plans.