FAQs
FDA Submission and Regulatory Pathway

Q3: How long does FDA 510(k) clearance take for a diagnostic device?

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The FDA’s official review clock for a standard 510 (k) is 90 days from the acceptance of the submission. In practice, total time from submission to clearance can take longer for a variety of reasons. The FDA may put a submission on hold to request additional information during interactive review or as a deficiency letter. If a deficiency letter is provided, the submission review clock would be paused until a complete response is provided. Most 510(k) submissions for IVDs are processed within 6-12 months of filing when the submission package is thorough and properly organized.

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The clinical evidence and design history file are two key factors in the time required for preparation and review. It is essential to analyze the complexity of these two artifacts and ensure they are well documented and defined with a clear predicate rationale. This decreases the likelihood of multiple AI requests for missing elements that could delay the timeline. 

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During our 10-year history working with IVD clients, Landrich Group has a 100% clearance rate and deep expertise supporting the pre-submission and FDA review process.