The Food and Drug Administration sent a letter to Johnson & Johnson's DePuy Orthopaedics, dated Dec. 8, warning the company that several of its hip, knee and joint replacement products were improperly marketed, according to a Wall Street Journal news report.
The FDA said some of the products didn't have the appropriate applications for premarket approval or investigational device exemptions, according to the report. Additionally, the FDA said DePuy planned to distribute 14 products marketed as custom devices without notifying regulators.
While a spokesperson from DePuy cited a precedent of custom medical devices being allowed exemptions to premarket approval for more than three decades, the FDA said the devices didn't qualify as custom devices because they were too similar to other DePuy products. The company believes it has complied with the FDA, but it will not provide the custom devices at this time, according to the report.
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While a spokesperson from DePuy cited a precedent of custom medical devices being allowed exemptions to premarket approval for more than three decades, the FDA said the devices didn't qualify as custom devices because they were too similar to other DePuy products. The company believes it has complied with the FDA, but it will not provide the custom devices at this time, according to the report.
Related Articles on Orthopedic Devices:
Alphatec Spine Names Mark Francois Senior Director of Investor Relations
Stryker Pays $15M in Marketing Settlement
VG Innovations Releases Spine Device for Low Back Pain