The 510(k) submission process remains a cornerstone of medical device regulation in the United States. As the industry continues to evolve, staying informed about the regulatory trends, and updates is essential for manufacturers aiming to bring innovative devices to the market. In this article, we will be discussing the latest developments and some key updates that you should look for this year and what they mean to you!
But, before we go further, let’s brush up on some basics.
What Is a 510(k) Submission?
For those unfamiliar with the term, a 510(k) is a premarket application submitted to the FDA to show that a medical device is just as safe and effective as one that exists in the market (known as a predicate device). This pathway is commonly used for Class II devices and some Class I devices.
How Many 510(k) Clearances Can We Expect in 2025?
With the continuous growth and innovation in the medical device industry, the FDA has been reviewing a steadily rising number of 510(k) submissions. The FDA completes a review of ~3,000 510(k) applications annually, a number that has been largely stable since 2007.
The increasing use of technologies such as digital health, wearable technology, and AI-powered diagnostic tools across the world is causing this increase. As there are increasing advancements in technology alongside, it is advised that companies applying for 510(k) become accustomed to the quick and competitive pace of the regulatory framework for these applications. With the expected rise in submissions, it’s crucial to stay informed about the recent updates the FDA has made to keep up with this rapid pace.
Key Updates to Keep an Eye On for 2025
What’s New from the FDA in 2025?
As we approach the end of February 2025, all device manufacturers should know that the FDA has reinforced the importance of some updates that were made in the previous years, while introducing some other significant changes to the 510(k) premarket notification program. Here’s a gist:
Mandatory Use of eSTAR for 510(k) Submissions
Starting October 1, 2023, the FDA made it mandatory for all 510(k) submissions to use the electronic Submission Template and Resource (eSTAR). Manufacturers must adhere to this interactive PDF format in order to prevent delays. Moreover, this will help them to facilitate a faster, more uniform, and more seamless submission procedure and will continue to be a very important part of the 510(k) submissions in 2025.
Quality Management System Regulation (QMSR)
On February 2, 2024, the FDA rolled out a new rule, which is now called the QMSR, that aligns the Quality System Regulation with ISO 13485:2016. Manufacturers have until February 2, 2026, to get their quality systems updated to meet these new requirements. In 2025, manufacturers must proactively ensure they meet the requirements of the QMSR by doing systematic gap analysis and subsequent implementation of the required updates to their quality systems.
Updated Guidance on Predicate Device Selection
In September 2023, the FDA shared draft guidance to help manufacturers pick the right predicate devices for their 510(k) submissions. The idea is to choose predicates that meet today’s safety and performance benchmarks and aren’t tied to any design recalls. While still in the draft stage, manufacturers pursuing 510(k) submissions in 2025 must consider this guidance.
Clarification on the Use of Clinical Data in 510(k) Submissions
The FDA also put out draft guidance about when you’ll need clinical data for your 510(k) submissions. This is meant to give manufacturers a clearer picture of what’s expected when it comes to data and submissions. The requirement of clinical data has long been a topic of discussion. This guidance helps shed some light on it and is highly recommended for manufacturers preparing a 510(k) submission.
Evidentiary Expectations for 510(k) Implant Devices
There’s a draft guidance from September 2023 that lays out what the FDA expects for implantable devices going through the 510(k) process. It’s all about making review standards more consistent and speeding up the clearance for these kinds of devices. Manufacturers of implants that plan to submit 510(k) applications in 2025 must have this guidance in their “go-to” references.
New User Fee Rates for Fiscal Year 2025
With the FDA updating the 510(k) fees yearly, manufacturers need to stay updated to the changes in fees.
- Effective October 1, 2024, the FDA has released revised user fees for fiscal year 2025. According to this, the annual establishment registration fee is $9,280.
- Unfortunately, there are no waivers for small businesses.
- 510(k) submission standard review fee is $24,335 while that for small businesses is $6,084. These fee structures will be applicable until September 30, 2025
If you’ve been working on your 510(k) submission since last year and plan to submit it this year, knowing about these fee adjustments is key to keeping the process smooth and compliant.
Artificial Intelligence (AI) in Medical Devices:
Apart from the key updates, this year, the FDA is also focusing on a few important regulatory initiatives to improve medical device oversight. For example, the FDA is prioritizing guidance on AI-enabled device software functions. A draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations” was published on January 7, 2025. The above document gives recommendations for the development, validation, and submission of functions of AI-enabled device software. It mainly highlights the importance of the product lifecycle to be transparent, perform monitoring, and manage risks.
Third-Party Review Program for 510(k):
On November 21, 2024, the FDA issued its final guidance on the 510(k) Third Party Review Program and the Third Party Emergency Use Authorization (EUA) Review processes. This document outlines the responsibilities of third-party review organizations in assessing 510(k) submissions and EUA requests during public health emergencies, with the goal of accelerating the availability of essential medical devices when they are needed most. This is important guidance to consider for your upcoming 510(k) submissions, as applicable.
Transition from EUA to 510(k) for COVID-19 Diagnostics:
To support long-term stability in the market, the FDA has recommended that manufacturers shift from EUA to traditional 510(k) submissions for COVID-19 diagnostic tests, as this move continues in 2025, it’s important to plan proactively.
With a plethora of key updates, proper planning and a solid understanding of the FDA expectations are required to navigate the 510(k) clearance process. At Elexes, our team of regulatory experts helps you succeed by navigating all the important updates and helping you take those into consideration for your upcoming 510(k) submissions. Whether you’re preparing your first 510(k) submission or ensuring your approach aligns with the latest FDA requirements, we’re here to help.
Don’t just take our word for it—explore our success stories to see how we have helped clients achieve their regulatory goals.
Have questions or need expert support? Feel free to reach out at jennifer@elexes.com and let’s discuss how we can assist you.
Let’s make 2025 the year of innovation and success!
