Are you curious about how to complete your FDA 510(K) submission this year, or if you’re even required to do so? Here’s what you’ll need to know.
Before a medical device can be legally sold on the open market, it must meet specific regulatory requirements. The requirements needed for different medical devices strongly depend on their particular device class. While many devices require Premarket Approval (PMA), that isn’t the case for all devices. For devices that don’t require a PMA, a 510(k) submission needs to be filed instead. But what is a 510(k) submission? Who is required to file one? And how are 510(k) submissions supposed to be prepared?
Thankfully, our medical device experts at Global Strategic Solutions are here to explain the essential components of 510(k) submission, so your business will know what it needs to take care of going forward. Please continue reading to learn more, and also consider contacting us if you’d like additional help going through the following submission process!
Related: How Medical Device Companies Raise Money – Build something people want
What is a 510(k) Submission, and Why is It Important?
In short, a 510(k) submission is a specific type of regulatory premarket submission made to the Food and Drug Administration (FDA) regarding Class I, II, or III medical devices that don’t require premarket approval. Also commonly referred to as a Premarket Notification, a 510(k) submission provides evidence of substantial equivalence, meaning that a medical device is sufficiently similar to another device while also being safe and effective for use. Devices are classified as substantially equivalent compared to a predicate device if they possess the same intended use, with the same or different technological characteristics that do not negatively affect safety and performance.
If manufacturers can prove their device has substantial equivalence, their submission will be published in the FDA 510(k) database. The manufacturer will communicate their device has been “cleared” by the FDA, not “approved.” This is a subtle difference, but it is the correct way to reference your 510(k) device.
Related: What Is The Difference Between Clinical Evaluation and Clinical Investigation?
Who’s Required to Complete a 510(k) Submission?
Approximately 50% of all medical devices released onto the market will require a 510(k) submission to be permitted for market sale by the FDA. Most Class I devices are exempt from 510(k) Premarket Notification requirements, while most Class II medical devices require a 510(k) submission and clearance. Many Class III medical devices require a PMA rather than a complete 510(k) submission. In short, this means the developers of certain Class I, II, and II devices may need to submit a 510(k). There are different 510(k) submissions, but this article will focus on the traditional 510(k) for teaching purposes.
Are you struggling to get your medical devices approved and ready for sale on the open market this year? Our expert medical device specialists at Global Strategic Solutions can help by providing access to a wide range of medical manufacturing consulting and data analytics services.
The 510(k) submission process takes considerable time and attention to complete correctly. Sadly, there is not a “510(k) form” per se that companies can quickly fill out and send to the FDA. Instead, submission requires a range of specific documentation to be compiled and submitted together for review. To make the process as straightforward and simplistic as possible, the FDA has graciously provided a specified guide to help businesses complete the 510(k) submission process, including an overview of the submission’s required format and content.
That said, navigating through and interpreting the FDA guidelines can be tricky, especially for newer players within the medical device manufacturing industry. Our team of medical device experts has taken the time to compile a shortlist of everything your submission will need to include and in what order. 510(k) submissions should consist of:
● Indications for device use
● Information on device classification
● A list and explanation of predicate devices
● Proposed device labeling and advertising
● Descriptions of device specifications (including photos, engineering schematics, and documents regarding unique standards or controls)
● Performance data from clinical testing (if applicable)
● Sterilization, biocompatibility, and expiration information for the device (if applicable)
● Guidance documents related to the specific device type
All documents required for successful 510(k) submissions must be carefully prepared and organized for the best chance of FDA clearance. Because many of the documents necessary for the submission are inherently developed throughout the design and development process of medical device creation, it can be helpful to start authoring a 510(k) submission in parallel with project development efforts. Doing so can help streamline the submission process and lower the chances of submission rejection.
A word of caution. There is a section that addresses whether the device is novel. Be careful here. This is not a marketing piece but a regulatory document. You are not trying to differentiate your product from the competition. You want to show substantial equivalence. You are trying to explain how your product is the same, but you may need to explain a few minor novel features.
Related: How to Write an SOP for a Medical Device
Final Factors to Consider
According to recent data, approximately 69% of 510(k) applications are rejected the first time they are presented to the FDA. While this percentage fluctuates each year, the fact is that the majority of submissions are usually denied and will need to be adjusted and resubmitted at least once before gaining FDA clearance. Unfortunately, this can put a severe damper on operations for many medical device manufacturers by preventing their technology from hitting the market for sale.
Thankfully, companies have the option to partner with expert consultation companies with vast levels of experience in getting medical devices approved for sale by the FDA. Our professionals at Global Strategic Solutions are proud to offer our services to medical device manufacturers currently operating across the globe to help ensure your devices receive the approval they need and deserve. We’ve worked with companies throughout the United States, Europe, and Asia to help expedite the medical device approval process by providing companies with a quick and affordable route to government approval and market access.
If your business is struggling to receive the approval it needs for its newly developed medical devices, please consider exploring our services to learn even more about everything we can do to help. Also, please consider exploring some of our expertly written resources for access to even more essential information on medical device development, approval, and more.
What’s in Your Strategy?
Getting a medical device properly tested, analyzed, and accepted for use on the open market can be very difficult, even for major companies with long histories of medical device manufacturing success. Thankfully, our experts at Global Strategic Solutions are here to help by providing access to a wide range of essential services.
David R Rutledge, Pharm.D., FCCP, FAHA
+1 (630) 846-0350 cell
David.Rutledge@GlobalStrategicSolutions.com