FDA 510k: Everything you need to know about preparing a premarket submission for medical devices
A 501k is a device classification that allows manufacturers to sell their products without first obtaining approval from the FDA, but only if they meet specific criteria. That is, an FDA 510k submission is the technical documentation required by the US Food and Drug Administration (FDA) to sell in-vitro diagnostic products (IVD) or medium-risk medical devices in the country. Preparing for this premarket can be challenging as it is fairly strict about how to organize your submission. It’s important that you know what you’re getting into before submitting your 510k.
It is an important document for anyone who wants to sell a medical device in the United States. So, this article will help you understand what it takes to prepare a 510k, and how to make sure that your submission meets all FDA guidelines. We will cover everything from registration with the FDA’s 510k database, drafting a summary statement, and assembling your technical file.
When it comes to 510k submissions, the FDA wants you to be as thorough and organized as possible. As a result, they have provided guidance on how 510k should be formatted for submission. It is important that your submission includes all of these sections so that the FDA can quickly scan through it:
- Summary Statement
- Technical File
You’ll notice that these sections are consistent from form to form when you’re preparing a 510k. This is because the FDA wants all of the information about your product in one place.
- The summary statement provides an overview of what your submission is about
- The technical file includes all of your research
- Labeling should include any instructions for how to use your product or warnings against misuse
FDA 510K Database Registration Form
You will need an ID number from the FDA’s 510k database in order to complete your 510k submission. The Database Registration form has a field for your ID number, so make sure to include that with the rest of the information you will need before submitting.
510k Labeling Requirements
There are certain labeling requirements from FDA. You’ll notice in some cases they ask for specific or general labeling requirements, while in others they give you a list of what to include. Labeling must also include the 510k number and describe any changes that have been made to a 510k since it was originally submitted.
- Labeling Requirements for Medical Devices:
It’s important that your 510k submission includes all the required information for any medical devices being sold on US soil. This includes instructions for use and warnings against misuse, directions for handling or dispensing the device, and a statement that 510k submission was prepared in compliance with FDA guidelines.
- Labeling Requirements for IVD Devices:
The FDA labeling requirements are stricter when it comes to devices used for testing blood, body fluids, or tissues. Every label must include information on how to use your product, as well as any warnings against misuse.
What is substantial Equivalence?
Substantial equivalence (SE) refers to a simplified procedure where the FDA applies less onerous requirements, such as fewer tests and data. The Agency can approve your device by comparing it to an already legally marketed device if there are sufficient similarities. If your device is substantially equivalent to a legally marketed 510k, then you can submit it under Section 510(k)(21)(A). Substantial equivalence means that your device is as effective and safe as the predicate. A new device is called substantially equivalent if:
- It has the same intended use as the predicate device
- Has the same technological characteristics as the predicate device or has distinct technological attributes but does not raise the questions of effectiveness and safety
Types of 510k Submissions
While everyone in the medical industry must be familiar with the term ‘501k,’ not many are aware that there are three different types of premarket notification. As a medical device manufacturer, you can submit any of the following 510k’s:
Please note that each 510k grants you permission by the FDA to market your product. Nevertheless, each one has different processes and benefits that medical device firms can take advantage of.
- The most common type of submission is the traditional 510k that is used to determine substantial equivalence with a predicate medical device that is already on the market. This type of 510k indicates the technological characteristics and use of the medical device. So, there are no mandated special conditions or circumstances to submit a traditional 510k if you have a predicate device picked out. Moreover, you don’t have to complete any special ‘form.’ A traditional 510k is just about submitting all the information required under 21 CFR 807.87.
- The second most common type of 510k is the Special 510k that is used by manufacturers to make a modification or any changes to the medical device that is already in the market. It was established in 1998 by the FDA to create an efficient review process for device modification and changes subject to 510k submission requirements. Special 510k requires you to provide summary information resulting from the design control process. This can provide a base for substantial equivalence. Overall, information required for special 510k submission includes analyzing and identifying risks associated with the change, the associated acceptance criteria, and the verification methods with results. Therefore, for a special 510k submission, you need to provide a design controls program that is compliant with 21 CFR 820.30 with sufficient information.
- The third and the last type of 510k is the abbreviated 510k that is used for determining substantial equivalence to a special control, recognized standard, or guidance using a declaration of conformity. Irrespective of its name, abbreviated 510k is not easier or shorter than traditional submission. In fact, it takes twice as long for the FDA to review. Substantial equivalence in abbreviated submissions is proven using the declaration of conformity or guidance documents to recognized standards rather than a predicate medical device to facilitate the organization’s review.
We hope this article was helpful in understanding the basics of FDA 510k submission. We have covered everything from the checklist to the type and more. Please go through the guidelines and seek professional help if needed before submitting FDA 510k for your new medical device.