FDA 510(k) Submission Process: An Introduction & How-To Guide

What is a 510(k) submission?

A 510(k) submission is a type of regulatory submission made to FDA called a Premarket Notification. In a 510(k), substantial equivalence to a predicate device on the market must be demonstrated. In other words, the medical device in question must be at least as safe and effective as a legally marketed device.

Who has to complete a 510(k) submission?

Certain regulatory requirements must be met before a medical device can legally be sold on the market. The medical device classification and product code defines these requirements. Most Class I medical devices are exempt from a 510(k) Premarket Notification, while most Class II medical devices require a 510(k). Many Class III medical devices require a different regulatory pathway called a Premarket Approval, or PMA. If Premarket Approval (PMA) is not required for the device, a 510(k) must be submitted unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act. Roughly 50% of all medical devices will need a 510(k) submission to be approved for market.

How do you prepare a 510(k) submission?

The 510(k) submission process takes time and attention to get right. There is no “510(k) form” to simply fill out and send to FDA. Instead, specific documentation will need to be gathered and submitted. FDA has issued useful guidance for preparing a 510(k), including an overview of the required content and format. However, navigating and interpreting the FDA guidance is where Gilero’s regulatory expertise can be extremely valuable. A complete application will be organized in a logical format and include the following information:

• Device classification
• Predicate device(s)
• Proposed labeling
• Description of the device and specifications, including engineering drawings, photos, etc.
• Performance data such as clinical testing (if applicable)
• Sterilization information (if applicable)
• Guidance document(s) specific to the device type, if such documents exist

As with any regulatory submission, it is critical to make sure that all required documentation has been included and prepared correctly. Many documents generated during the medical device design and development process can be used when preparing the 510(k), so it is advantageous to begin authoring a 510(k) in parallel with product development efforts. Engaging with a medical device firm that offers regulatory consulting alongside design and development can help to streamline and simplify the 510(k) submission process.

Do you need to work with a regulatory consultant?

Navigating FDA regulations for medical devices can be difficult and overwhelming. Careful planning, thorough documentation and an understanding of the regulatory environment are key components for a successful 510(k) submission to FDA. Thankfully, there are medical device development firms with expertise in the regulatory space. Working with a company like Gilero, who offers regulatory consulting as a part of the medical device design and development process, can be beneficial for planning a clear pathway to get your medical device approved for sale in the US market.