NuVasive Inc – FDA Warning Letter, Nov 2, 2012

On March 12, 2013, the FDA issued a Warning Letter to NuVasive, Inc. following an inspection from October 29 to November 2, 2012, at their San Diego, California facility. The inspection revealed that the firm's Affix Spinous Process Plate System, a medical device, was adulterated under section 501(f)(1)(B) of the Act because NuVasive lacked an approved Premarket Approval (PMA) application or an Investigational Device Exemption (IDE). Additionally, the device was found to be misbranded under section 502(o) due to the firm's failure to submit a 510(k) premarket notification before introducing the device into commercial distribution. A significant deficiency noted was the marketing of the Affix plate for a new intended use—specifically, with only an intervertebral body fusion device—without obtaining a new 510(k) clearance, as required by 21 CFR 807.81(a)(3)(ii). The FDA mandates prompt corrective action to address these violations, requiring a written response within fifteen business days detailing specific steps taken, preventative measures, and a timetable for any ongoing corrections. Failure to comply could lead to severe regulatory actions, including seizure, injunctions, civil money penalties, and impact on federal contracts, indicating potential systemic issues in the firm's quality and regulatory management.