Debate Grows Around Timeliness Of FDA Close-Out Letters; Warning Letters Going Out Faster
• By Shawn M. Schmitt
Writing a thorough warning letter response just might help a manufacturer receive an FDA close-out letter more quickly. A well-crafted response can help the agency decide whether to close out some warning letters without performing a reinspection. “If we can conduct a paper review of a firm that has revamped its MDR [Medical Device Reporting] processes, and we find those MDR processes acceptable based on the paper review, then we may be able to close out the warning letter,” CDRH Office of Compliance Director Steven Silverman said. Because it can take a long time for FDA to revisit a firm, the close-out process has slowed to a crawl, some experts say. In warning letter news, FDA is pushing letters out the door faster. There were 121 quality-related letters posted on the agency’s website in 2011, an increase of 30 percent over the prior year.
Device manufacturers looking to quickly resolve an FDA warning letter – and secure a close-out correspondence – should make sure they pen a thoughtful, detailed and rapid response to the agency.
It’s more important than ever to construct a stellar warning letter response because “there are situations when we’re able to...
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