The FDA’s 510(k) process is a key regulatory pathway for medical devices seeking market clearance in the United States, allowing companies to demonstrate that their device is substantially equivalent (SE) to an existing legally marketed device, known as a predicate. This pathway enables faster market entry when compared to a full premarket approval (PMA) and is particularly beneficial for low- to moderate-risk devices.
Here’s a breakdown of the review process, timeline, and tools like eSTAR that streamline submission and review.
There are three types of 510(k) submissions:
Traditional 510(k) – The most common type, used for new devices or substantial modifications to existing ones.
Special 510(k) – For changes to a manufacturer’s own cleared device, provided that well-established methods for assessing changes exist.
Abbreviated 510(k) – Used when relying on FDA guidance documents, special controls, or consensus standards to demonstrate SE.
eSTAR for Streamlined Submissions:
Recently, the FDA introduced the eSTAR (electronic Submission Template And Resource) template, aimed at improving the consistency and efficiency of 510k submissions. The eSTAR template provides a structured, interactive PDF format designed to align closely with the FDA reviewer templates, creating a standardized approach that enhances transparency and completeness in submissions. This template streamlines the review process by pre-formatting information and automating data checks, potentially reducing the time for FDA feedback and the need for multiple revisions.
Overview of the typical review stages from submission to clearance for Traditional 510(k) submissions.
Pre-Submission Preparation: Manufacturers may engage with the FDA through Q-Sub (Pre-Submission) meetings to clarify submission requirements and address questions related to their device. This step helps ensure completeness, reducing delays later in the review process.
Technical screening process: This process is anticipated to occur within 15 days of the FDA receiving the 510(k) eSTAR. If the proper user fee has not been paid or a valid eSTAR has not been provided, the FDA will notify the submitter by email and identify the incomplete information, and the 510(k) will be placed and remain on hold until a complete replacement eSTAR is submitted to the FDA. If a replacement eSTAR is not received within 180 days of the date of technical screening deficiency notification, the FDA will consider the 510(k) to be withdrawn, and the submission will be closed in the system. The technical screening review time does not impact the review clock for files that pass the technical screening. For a submission that passes technical screening, the review clock starts on the day the submission was received by the FDA.
Substantive Review: During the substantive review, the reviewers evaluate whether the device is "substantially equivalent" to a predicate device and assess the device’s safety and efficacy data, risk assessment, and compliance with regulatory standards. The reviewer communicates with the submitter through a Substantive Interaction, which should occur within 60 calendar days of receipt of the 510(k) submission.
The Substantive Interaction communication is typically via Interactive Review or an Additional Information (AI) request.
Interactive Review: : In this stage, the submission is not placed on hold. The Lead Reviewer communicates with the submitter during the Interactive Review using tools such as email or telephone calls.
Additional Information(AI) Request: Issued by the FDA when the manufacturer needs to respond to questions or provide more data. Manufacturers are allotted up to 180 days to address the AI request. The submission is placed on hold, and the FDA review clock only resumes once the response is received.
Decision Phase: The FDA’s goal is to complete most 510(k) reviews within 90 days after completing all reviews, though the process can extend based on the complexity of the device, any additional data requirements, or time taken by the applicant to address review questions. If the device is deemed substantially equivalent, the FDA grants 510(k) clearance, allowing the device to be marketed in the U.S. If not, the FDA may issue a "Not Substantially Equivalent" (NSE) letter, which requires the applicant to submit a new 510(k) or pursue other regulatory pathways.
We are here to help address your questions and guide you through each step of the FDA’s 510(k) submission process.
Whether you need assistance structuring a complete 510(k) submission—including device safety and efficacy data, risk assessments, and predicate device comparisons—or preparing for AI requests, our team is ready to assist.
Let’s work together to streamline your pathway to market clearance!
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