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FDA Warning Letters

This article was originally published in The Silver Sheet

Executive Summary

WARNING LETTERS: Baxter citations follow FDA inspections at seven facilities; Philips failed to establish procedures for complaint handling and Medical Device Reporting, FDA says

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New tactic: Warning letters to health care providers

On Oct. 27, FDA sent warning letters to 17 ambulatory surgical centers that perform laser-assisted in situ keratomileusis (LASIK) procedures, citing the facilities for failure to develop, maintain and implement written Medical Device Reporting (MDR) procedures. (See "1Warning Letters") CDRH has also stepped up communications with health care facilities and professional societies to clarify the agency's requirements for MDR reporting. CDRH Office of Compliance Director Tim Ulatowski says it's "vitally important" that user facilities, and not just device manufacturers, comply with MDR regulations. Under the regulation, hospitals and other user facilities must submit a report to both FDA and the manufacturer when a device may have caused or contributed to a death. When it may have caused or contributed to a serious injury, the facility generally only needs to tell the manufacturer. "If the manufacturers aren't getting the reports and FDA is not getting the reports from user facilities when necessary, then the whole system breaks down, or is at least in jeopardy," Ulatowski says. "We need to be receiving these reports so we can properly assess in a post-market period how these devices that are involved in LASIK procedures are performing.

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