Introduction:
A 510(k) clearance is a process by which medical device manufacturers notify the FDA of their intent to market a new device that is substantially equivalent to a legally market device.
Submitting a 510k to the FDA is an important step for any business or healthcare product that needs to be approved for sale. Knowing when the time is right to submit can be tricky, but with this guide, you’ll be able to prepare yourself and submit your 510k with confidence.
Become Familiar with relevant FDA Medical Device Regulations:
It is important to be familiar with the specific regulations that apply to your product and its type so that you know when it is time to file a 510k submission. Understanding deadlines, required documentation and what must be included in the submission are all key components of filing successfully. Take the initiative to research and understand the requirements associated with submitting a 510k.
Demonstrate the Substantial Equivalence between Your Device and Predicate Devices:
Identifying a predicate device that is substantially equivalent to your device is very critical to the success of your 510(k) application. It is also essential to analyze any similarities and differences between your device and the predicate device(s) before you submit a 510k. This will help you determine if you are subject to certain regulations or not.
In determining if a product is considered substantially equivalent to a chosen predicate device, the FDA has set specific criteria, including: the device has the same intended use and technological characteristics as the predicate device; or the product has the same intended use as the predicate device, yet has different technological characteristics and does not raise any new questions regarding safety and effectiveness; and the data submitted to the FDA can demonstrate that the device is at least as safe and effective for use in patients as the marketed device.
Analyze the Differences between Your Medical Device and Predicate Devices:
It is essential to analyze any difference between your device and the predicate devices before you submit a 510k. Analyzing similarities and differences can help you determine if you are subject to certain regulations or not. When reviewing differences, focus on major characteristics such as structure, function, materials, physical properties, chemical composition, and performance data. Make sure to have a clear understanding of the differences for your submission to be successful.
Consider Your Type of Medical Device 510k Submission:
Before you submit your 510k, it’s important to consider the type of submission that best describes your device and its intended use. There are three types, including: traditional 510k, abbreviated 510K and special 510K. The Special 510(k) and Abbreviated 510(k) submission types can be used when a 510(k) submission meets certain factors, however, the Traditional 510(k) can be used under any circumstance to seek marketing authorization of a device. In a Traditional 510(k), the submitter provides descriptive information about the indications for use and technology and results of performance testing to demonstrate substantial equivalence.
Meanwhile, Abbreviated 510(k) application relies on “summary reports” that briefly describe and summarize the testing performed to support the submission as recommended in relevant guidance document(s). These reports summarize the device description, the manufacturer’s device design requirements, risk management information, and a description of test methods used to address performance characteristics.
Research Any Significant Design Changes to Your Medical Device or Manufacturing Process:
As you prepare to submit your 510k, consider any design changes to either the device or its manufacturing process. Significant design changes could require you to file a traditional 510k instead of an abbreviated one. Research the differences between the predicate devices used in similar submissions and gather data to demonstrate your device’s safety and effectiveness if needed. Additionally, research any labeling updates or clinical studies that may be necessary before submitting your application.
Know the Use of Clinical Data Requirements in the Submission Process, if Applicable:
The FDA may require clinical data with your submission to demonstrate the safety and effectiveness of the device. The FDA considers this data when determining whether a device poses risks, so understanding these requirements is essential. A few common scenarios where clinical data is necessary include a novel technology, changes in an existing device’s indications for use, or any changes that could result in increased safety risks for patients. Gather all relevant population, usage, and performance studies to include with your submission.
Our experts at Quality Smart Solutions are here to help and offer medical device-related regulatory advice and support on successfully securing your medical device license. We can help you by responding to potential information requests, keeping your license updated, and reviewing your device labels (510k Medical Device Registration, Facility Registration & FURLS, IVD Device Registration, and SaMD Classification.
