Merit Medical Ireland Ltd. – FDA Warning Letter, Sep 15, 2011

On January 30, 2012, the FDA issued a Warning Letter to Merit Medical Ireland Ltd. following an inspection from September 12-15, 2011, in Galway, Ireland. The inspection and subsequent communications revealed that Merit Medical Ireland Ltd. modified the hydrophilic coating process for its Laureate Hydrophilic Guidewires.

This modification is considered a significant change under 21 CFR 807.81(a)(3)(i) because it could significantly affect the safety or effectiveness of the devices. Consequently, the Laureate Hydrophilic Guidewires are deemed adulterated under Section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), as the firm lacks an approved premarket approval (PMA) application or an investigational device exemption. The devices are also misbranded under Section 502(o) of the Act, 21 U.S.C. § 352(o), for failure to submit a 510(k) notification to the FDA prior to commercial distribution.

Merit Medical Ireland Ltd. was instructed to notify the FDA in writing within fifteen business days of receiving the letter, detailing specific corrective steps taken, plans to prevent recurrence, and documentation of corrections. If corrections require more time, a timetable for implementation must be provided.