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501(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 the 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 income case may mean not learning about issues in advance that may turn into additional 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.

Substantive Interaction communication is typical:

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

510(k) Transfer of Ownership

A 510(k) for a medical device can be thought of as a patent making a 510(k) transfer of ownership, say following a sale, for example, a particularly important process to follow. The FDA published draft guidance entitled “Transfer of a Premarket Notification (510(k)) Clearance. Although there are no official regulations or guidance on 510(k) transfer of ownership, there are practical considerations from the withdrawn draft guidance that remain prudent to follow.

It’s important to remember FDA only allows a 510(k) holder to transfer clearance without a new 510(k) clearance absent a significant modification of the device and there may be only one 510(k) holder at a time. 

Notice of a 510(k) transfer of ownership, even before the withdrawn draft guidance, is accomplished via compliance with device listing requirements.  The transferor notifies FDA by de-listing the device, and the transferee notifies FDA by newly listing the device.

Under 21 CFR part 807, listing a 510(k) device as a manufacturer, specification developer, repacked/relabeled, single-use device reprocesses, or remanufacturer, signals to FDA that the party executing that listing is the current 510(k) holder for that device because these entities are responsible for the commercial distribution of the device.

This means the consent of the transferor is implicit to this process since the party must actively de-list the device. In some cases, this is not a problem but in others the two parties may be hostile, even suing one another.

No matter the case, the withdrawn draft guidance recommended a, “… a legal instrument such as a contract or will, and/or other documentation of the sequence of historical transfers of the 510(k) clearance, up to and including the current holder” as evidence of ownership.

A sales agreement or other contract should be used to memorialize the transfer of ownership. It could also be something like a court judgment. If it’s a sales agreement then key terms would merit including to facilitate a smooth notice and transfer of ownership with the FDA.

In summary:

The transfer of ownership should be reflected in a contract or other legal instrument;

The contract should include provisions to facilitate the appropriate notifications to the FDA;

The new 510(k) owner should assess the device currently on the market against the 510(k) to determine if any changes require a new 510(k);

The previous 510(k) owner (the transferor) will need to de-list the device;

The new 510(k) holder must register as a “manufacturer, specification developer, repacked/relabeled, single-use device preprocessors, or remanufacturer” and list the device.

Premarket Notification(510k)

A 510k is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate”.

FDACE PRO can assist you to prepare your Traditional, Abbreviated, or Special 510k submission to FDA.

                           501 K approval process flow diagram