510(k) Process

510(k) Process

There are many questions about the 510(k) process, but none is more common than, “how long does it take?”

The stock answer of 90-days of FDA review time tells only half the story. There are many factors that can impact the timing to complete the 510(k) process.

Preparing and Pre-Submissions

Naturally, before the 90-day statutory clock can even begin, a 510(k) must be prepared. The time to prepare a 510(k) varies depending on what non-clinical data or validation is required. For example, biocompatibility and shelf-life studies can take 90-120 days to complete. The good news is fewer than 10% of 510(k)s require human clinical data, which is the most expensive and time intensive data needed.

Another factor in preparing a 510(k) that could add time is use of a pre-submission (a/k/a pre-sub). A pre-sub, “… provides the opportunity for a submitter to obtain FDA feedback prior to an intended premarket submission.” There is no filing fee for a pre-sub and feedback to specific questions is provided in writing in 65-70 days with a teleconference held on the 70th day. The pre-sub is not a required part of the 510(k) process but can be helpful where there are few predicate devices, most predicates are older, or alternative testing methods are sought like no animal biocompatibility testing. Skipping a pre-sub in come cases may mean not learning about issues in advance that may turn into addittional information requests.

Before a 510(k) is even filed testing and a pre-submission can add around 120-190 days (almost 6-months) to the timeline.

510(k) Process — Refuse to Accept (RTA)

Once a 510(k) is filed to the Document Control Center (DCC), and you navigated past any annoying e-Copy holds, the 90-day statutory clock doesn’t immediately begin. The FDA has a Refuse to Accept Policy for 510(k)s that must be cleared first.

The RTA begins with an acceptance review, which occurs prior to the 90-day substantive review, and is conducted and completed within 15 calendar days of FDA receiving the 510(k) notification. That means 15-days, two weeks, is tacked onto the 510(k) review process before the 90-day clock begins.

If an RTA is issued, meaning the submission fails the acceptance review and cannot proceed to the substantive review, then the FDA provides 180 days to respond, which could involve collecting data. If a response to the RTA notification is not received within 180 days of the date of RTA notification, then the FDA will consider the 510(k) to be withdrawn and the submission will be closed in the system.

Only once the RTA is cleared is an acceptance letter issued which officially begins the 90-day statutory clock.

510(k) Process — Additional Information Requests

During Substantive Review, the Lead Reviewer conducts a comprehensive review of the 510(k) submission and 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:

  • an email stating that FDA will proceed to resolve any outstanding deficiencies via Interactive Review; or
  • an Additional Information (AI) request which places the submission on hold for 180-days.

Depending on the nature of the AI request a response may be submitted sooner than 180-days. Once submitted the review clock re-starts, typically with 20-30 days of review time remaining.

10.75 Appeal

The 510(k) process may not end when a determination on Substantial Equivalence is provided. In some cases, an unfavorable decision may be appealed under 21 CFR 10.75. This process can add 60-120 days of preparing and review time.

510(k) Process

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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