Our Specialty – FDA Premarket Notification 510(k)s
Our expert regulatory experts will prepare a successful 510(k) submission for your new product or a design change to an existing product. Are you unsure if your product or design change will require a 510(k) to be sold on the US market? Contact us and we will be glad to provide a regulatory evaluation and project quote.
U.S. marketing applications for low- and moderate-risk devices
A 510(k), also known as a premarket notification, is an FDA marketing application to grant US market access for most Class II (moderate risk) and some Class I (low risk) medical devices.
The term 510(k) refers to that section of the Food, Drug and Cosmetic Act that requires manufacturers to submit a premarket notification for a new device or significant modifications to an existing product. The goal of the 510(k) is to prove that the device is substantially equivalent (at least as safe and effective) to a similar device that is currently sold on the US market.
Types of 510(k)s
There are three types of premarket notifications – Traditional, Abbreviated, and Special. The traditional 510(k) is the original form of the submission that was created following the Medical Device Amendments (MDA) of 1976. It is the longest submission version and is typically used for new products and significant product design changes. The abbreviated 510(k) shares the same basic format as the traditional, but will contain less data and fewer reports. This is because the abbreviated submission relies on conformance to guidance or industry standards. The Special 510(k) is for minor product design updates made in accordance with design control requirements.
Structure and content
The FDA provides submission-specific guidance for all three types of 510(k)s. In addition, the agency has published a number of guidance documents that provide recommended submission content based on the type of product. A submission will typically follow the recommended 20-section format, but in some cases information can be summarized instead of providing extensive test data.
Electronic submissions
The Center for Devices and Radiological Health (CDRH) announced in 2022 that for the first time it would accept all-electronic 510(k)s. And after October 1, 2023, all device submissions must be submitted electronically. Read more.
We can help
Contact Medical Devices and Pharma to see how we can provide professional 510(k) compilation, preparation, and formatting services for your upcoming premarket notification submission. And submit the 510(k) to FDA in an all-electronic format.