Introduction of the 510k application to the FDA.
One of the most common question from our clients in the initial interview is:
“How long does it take for the FDA to clear a 510k?”
In theory the FDA’s timing for a 510K application is clearly set out in its official timeline (see Figure 1). However, it is important to know that during the review phases that occur on day 15 and, day 60, it is very common for the reviewer to require some additional specifications, tests or changes to the document; when this occurs, the FDA ‘clock’ pauses, until it receives the missing information. Hence, the current time average of 510K in the last five years is 177 days. Of which 90 are attributable to the FDA and the additional 87 to the applicant.
That is why it is extremely important for the applicant to have experienced consultants by his/her side, who understand both, the mindset of the regulatory body and the dynamics of small and medium-sized enterprises; this successful combination allows you to establish a strategy to reduce the real-time of the application process.
Next, let’s take a closer look at the steps and times required for your 510k approval.
This step, according to the official schedule, spans from day 1, when the application is received, to day 7 where the FDA will have to give a response.
One of the following 2 situations can occur here:
(1) The FDA issues an official communication called “Acknowledgement Letter” indicating payment compliance and the successful receipt and download of the electronic version of the document by the system. At this point the official number (K number) is assigned to your device or product and the request starts to undergo the established process.
(2) The FDA issues a letter of suspension of receipt called “Hold Letter“. This occurs if the FDA does not find the correct payment receipt; or, if the electronic file has any defects that prevent it from being download to the system. Generally, this situation can be resolved quickly and easily.
In this step, the FDA makes a procedural evaluation of the application using a checklist (RTA Checklist), ensuring that the received document contains all the information necessary to proceed to the Substantial Review (Next Step). In this regard, the FDA will issue a notification approximately 10 days after the K number is granted stating, if the application has been accepted or rejected, taking into account the review criteria described in the checklist.
If the application was rejected, the applicant will be granted up to 30 days to correct for errors or missing documents.
Note: As we said above, if your application is not accepted,the estimated 15-day calendar time from receipt of the application (in the official calendar) will be increased by the response time you’ve spent resolving the issues encountered.
Once the application has been accepted, it enters the Substantial Review phase. The FDA team in charge of this will evaluate in detail the information that was provided to demonstrate substantial equivalence (similarity of the device presented with the device chosen to be compared in terms of technical characteristics, indication of use, etc.), as well as the safety and efficiency of the device.
During the next 45 calendar days following acceptance for the review of the application, the FDA will send an email to inform of one of two possible scenarios: in the first, it will indicate that the review of the submission will continue interactively, meaning that the FDA considers the problems in the application to be minor and can be resolved within 30 days; while in the second scenario, the FDA will deliver a Deficiencies List along with an Additional Letter of Information.
In an interactive review the FDA will ask some questions and request some clarifications that in most cases can be resolved between consultant and client in a relatively short period of time. The review clock will continue to countdown and we will be able to obtain the Final Decision within 30 days.
Alternatively, if the FDA issues an Additional Letter of Information, the FDA review clock stops and you will have up to 180 days to respond to the letter of deficiencies. In 2018, 63% of 510 Ks approved received an Additional Letter of Information. This period of 180 days is usually the reason for the increase in the average review time. Once the response to the deficiencies of the Additional Information Letter is sent, the FDA clock resumes, and, usually another 30 days remain until the final decision.
At the end of the review period, the FDA will issue its Final Decision (Substantially Equivalent [SE] or Non-Substantially Equivalent [NSE]).
To illustrate the procedure, we created the following infographic with the average development of a 510k application.
Introduction of the 510k application to the FDA.
Letter of acceptance of the application. Assignment of the K number.
It was REJECTED. The FDA requested some missing documents in the application. You have up to 180 days to respond.
15 days after receipt of the letter, missing documents were included
5 days later it is approved for Substantial Review.
It was REJECTED. Additional Information Letter is received. You have up to 180 days to respond.
Additional corrections and tests requested by the FDA were addressed and included.
The FDA requests some minor changes. It will be solved interactively.
The Device Substantial Equivalence (SE) decision is received via email
The timeline provided above refers only to the times and phases that the application will undergo during its review process by the FDA.
The preparation time of a request for the application of a 510K depends on multiple factors; many of them inherent to the type of product and its level of development, as well as the ability and dedication of the applicant company to provide the necessary information. Because of these factors, it is difficult to determine a priori, the exact time it will take to prepare the application; we have cases of less than 30 days and we have also seen some take over 6 months.
However, regardless of the company’s situation, Compliance 4 Devices customers will always provide our constant support and advice throughout every step of the way.
Here’s a simple explanation of what a pre-marketing submission (510k) request for your medical device is
You’ll be able to learn about the 510k app’s reduced rate program for small businesses.