Service(s) related to this article:  510K & Canadian Medical Device Consulting

As you are planning the commercialization of a new medical device for the US market you will want to consider what options are available to you from a regulatory standpoint including the FDA 510(k) path. There are two main pathways which a device can come to market in the US. The first is the “Premarket Approval” process and the second and more common is a “Premarket Notification” also known as the FDA 510(k) process.

The role of the FDA 510(k) is to gain marketing clearance for a medical device in the US. However, in order for a medical device to be eligible for the FDA 510(k) process the device must be “substantially equivalent” in both safety and efficacy to another lawfully marketed device already on the market in the US. This previously marketed device is termed the “predicate device”. An important first step in the FDA 510(k) process is determining the best “predicate device” that will set up your 510(k) to be successful.

For a FDA 510(k) there is no Premarket Notification 510(k) “form” to complete. A 510(k) is a document containing information required under 21 CFR 807 Subpart E. All 510(k)s provide a comparison between the device to be marketed and the predicate device or devices. To be considered substantially equivalent to the predicate device your device does not need to be identical. Instead, you must be able to show substantial equivalence through the comparison of a variety of factors including: intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards, and other applicable characteristics. The nature of this comparison depends on the device and the degree of risk associated with its use.

Another thing to consider when looking at the FDA 510(k) process is that several devices requiring Premarket Notification are subject to “Special Controls.” Special Controls can be almost anything which the FDA’s Center for Devices and Radiologic Health (CDRH) determines is necessary for devices of that particular type. These Special Controls can be specialized labeling, conformance to specific standards or the design. Special controls are carefully determined by CDRH and made available to all.

A successful 510(k) submission results in FDA permission to market the new device for a specific intended use in the US. If you are looking to enter the US market with your new device, dicentra can provide all of the services necessary ranging from regulatory strategic planning and product classification to establishment registration all the way to FDA 510(k) filing.

dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the health sciences and food industries.  We evaluate, implement and provide all the necessary support for your products and operations to gain market access and build confidence in your brand.  Contact dicentra at 1-866-647-3279 or visit dicentra.com to learn more about us and our services.