FDA WARNING_LETTER - MicroPort Orthopedics Inc.

This Warning Letter informs MicroPort Orthopedics, Inc. of its failure to comply with postmarket surveillance requirements under Section 522 of the Federal Food, Drug and Cosmetic Act and 21 CFR Part 822. The firm inherited a postmarket surveillance study order (PS110070) for several Metal-on-Metal Hip System devices after acquiring them from Wright Medical Technology, Inc. in 2014. Despite multiple rejections of proposed study plans and explicit guidance from the FDA, MicroPort failed to design an approvable plan to answer the questions in the order or to conduct surveillance according to previously approved plans, violating 21 CFR §§ 822.11 and 822.20. Specifically, the firm did not revise its submission to address concerns from a November 2014 not approvable letter, and its submissions have not fully addressed all questions in the 522 order. This non-compliance is a prohibited act under Section 301(q)(1)(C) and renders the devices misbranded under Section 502(t)(3) of the Act. MicroPort is expected to complete an approved study plan without further delay and initiate the study within 45 days of receiving this letter or 60 days of plan approval. Failure to promptly correct this violation within 15 calendar days may result in regulatory actions such as seizure, injunction, and civil money penalties, and may impact federal contract awards.