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Overview of FDA timelines associated with Traditional 510(k)s

January 22, 2021  •  Blog  •  Becky Ditty, Consultant
Posted In Medical Device News & Insights – Biologics Consulting  •  Tagged 510(k), substantive, acceptance, timeline, AI, traditional, MDUFMA, performance, review, RTA, FDA, substantial equivalence

Introduction

The Medical Device User Fee Act (MDUFMA) I, signed into law on October 26, 2002, authorized FDA to collect user fees for various marketing applications, including premarket notifications (510(k)s). The fees are intended to be used by FDA on the resources needed to support the review of marking applications in a reasonable time period.  MUDFMA I outlined the FDA performance goals for the marketing applications for fiscal year 2003 through 2007.  The performance goals and user fees were then modified via subsequent MDUFMAs. This article explains the 2021 FDA performance goals for Traditional 510(k)s, how these goals relate to the review process (including review cycles) for a Traditional 510(k) and includes an example timeline based on the performance goals and the review cycles.

Traditional 510(k) Performance Goals

FDA performance goal is to review 95% of the traditional 510(k)s they receive within 90 FDA days.  FDA Day 1 is the day FDA considers a complete submission has been provided (this is either the day FDA initially received the submission, or, if the submission receives an RTA then Day 1 is the day the submitter has successfully responded to an RTA.) The phase to determine if a submission is complete is called the ACCEPTANCE REVIEW phase. Once FDA determines they have received a compete submission, the review enters the SUBSTANTIVE INTERACTION phase.

The FDA clock stops once FDA provides an AI request (if necessary). This is typically done by FDA Day 60. The submitter then has 180 day to response in full to the AI request (This is the RESPONSE TO AI REQUEST phase). Once FDA receives a complete AI response from the submitter, or if FDA determines there is no AI request, the FDA clock restarts, the submission enters the INTERACTIVE REVIEW phase and FDA has approximately 30 days to reach a MDUFMA decision.

Phase (also called Review Cycles) Details

Acceptance Review – Within 15 calendar days of receipt, FDA will conduct an Acceptance Review to determine whether the submission is complete and can be accepted for substantive review. If the submission has been found incomplete, within 15 calendar days FDA will notify the submitter that the submission has not been accepted and identify those items that are the basis for the refuse to accept (RTA) decision and are therefore necessary for the submission to be considered accepted. The submission will be placed on hold and the review clock will not start until the missing elements are provided. For additional information, please refer to the guidance, “Refuse to Accept Policy for 510(k)s“. This communication represents a preliminary review of the submission and is not indicative of deficiencies that may be identified later in the review cycle.

Substantive Interaction – Once the submission has been accepted for review (i.e., after the RTA phase of review), FDA will conduct the substantive review and communicate with the submitter through a Substantive Interaction within 60 calendar days of receipt of the accepted 510(k) submission. The Substantive Interaction communication can be an AI request (A letter identifying items FDA needs clarification on or additional information such as testing. These items are called “deficiencies”) or an email stating that FDA will continue to resolve any outstanding deficiencies via Interactive Review (this means FDA has no significant deficiencies and therefore any questions FDA has during the rest of the review should be minimal and can be answered quickly).

Response to an AI Request – A response to an FDA AI request is the submission of additional information addressing all of the deficiencies identified in the AI request. The response allows FDA to continue or complete the substantive review and reach a decision on the 510(k) submission. The submitter must provide a complete response to an AI request from FDA within 180 days, otherwise FDA will consider the submission withdrawn. The response should address all deficiencies identified by FDA in its AI request to be considered a complete response. The submitter’s submission of a response to an AI request is an action that, upon receipt by FDA, resumes the FDA review clock, i.e., the 90-day review clock resumes upon receipt of the additional information.

Interactive Review – Once the submitter responds to an AI request, or once the submitter receives an email stating that FDA will continue to resolve any outstanding deficiencies via Interactive Review, the FDA will have approximately 30 days to finish the submission review and reach a MDUFA decision (substantial equivalent or not substantially equivalent).

A visual timeline is provided in the White Paper, located here.

For additional details, refer to FDA guidance document: FDA and Industry Actions on Premarket Notification (510(k)) Submissions:  Effect on FDA Review Clock and Goals.

* FDA days begin on the date of receipt of the submission or of the amendment to the submission that enables the submission to be accepted. Once an application is “Accepted,” the FDA review clock begins as of the date of receipt of the most recent submission or amendment that made the 510(k) complete (from Refuse to Accept Policy for 510(k)s ).

**60 days from the date of receipt of the most recent submission or amendment that made the 510(k) complete

Information based on:

Food and Drug Administration (FDA). (2021) Refuse to Accept Policy for 510(k)s Guidance for Industry and Food and Drug Administration Staff. Retrieved from source.

Food and Drug Administration (FDA). (2021) FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals Guidance for Industry and Food and Drug Administration Staff. Retrieved from source.