Wu, Helen K. – FDA Warning Letter, Jul 22, 2009

The FDA issued a Warning Letter to New England Eye Center, Tufts Medical Center, following an inspection on July 22, 2009. The facility, identified as a medical device user facility, was found not in conformance with Medical Device Reporting (MDR) regulations (21 CFR Part 803) regarding ophthalmic lasers used for LASIK procedures. Specifically, the LASIK devices were deemed misbranded under section 502(t)(2) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(t)(2), due to the firm's failure to furnish required material or information under section 519 of the Act, 21 U.S.C. 360i, and 21 CFR Part 803. A significant deviation noted was the failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. The FDA requires prompt corrective action, including a written response within fifteen working days detailing specific steps, prevention plans, documentation, and a timetable for implementation. Failure to correct these violations could lead to regulatory actions such as seizure, injunction, or civil money penalties, and may affect federal contracts. The letter emphasizes the firm's responsibility to ensure overall compliance and investigate the root causes of the noted issues.