FAQs
FDA Submission and Regulatory Pathway
Q1: What are the steps for submitting an In Vitro Diagnostic (IVD) to the U.S. Food and Drug Administration (FDA)?
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FDA clearance or approval for an In Vitro Diagnostic (IVD) device requires several steps leading to submission. The first step is determining the correct regulatory pathway. Medical devices and diagnostics have three primary potential pathways: the 510(k), De Novo, or Premarket Approval (PMA). A Biological License Application (BLA) represents a fourth, less-used regulatory pathway for IVDs for blood screening products.The pathway is determined based on two factors: the device’s associated risk level and the existence of an equivalent product already cleared or approved that can serve as a valid predicate.
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Once a pathway is determined, a submission package or technical file is prepared for submission. This should include analytical and clinical performance data, a completed design history file, manufacturing information, a risk management file compliant with ISO 14971, and device labeling consistent with the intended use claim.
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Most IVD submissions also benefit from an FDA pre-submission. This provides a formal opportunity to get regulatory agency feedback on proposed intended use claims, study designs, and proposed predicate or comparator devices before a pre-market authorization submission. Landrich Group supports IVD companies throughout the full process, from regulatory assessment through submission, FDA correspondence, and clearance or approval for U.S. market authorization.
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Typical design and development timelines for an IVD, depending on the complexity and availability of predicate and comparator devices, are approximately 2 years on average. FDA pre-sub meetings, which have a 70-day turnaround time, are highly recommended. The FDA’s MDUFA review time for 510(k) submissions is 90 days, but average review times are closer to 150 days based on interactive review, requests for additional information, and deficiency letters. FDA’s review times for higher-risk Class III PMA devices are 180 days, with the average review time exceeding a year if deficiencies are found or additional amendments are submitted. De Novo 510(k) devices have MUDFA FDA review times that fall between 510(k) and PMA FDA review times. Well-planned pre-sub meetings and high-quality submissions can minimize time to market authorization.