Understanding the 510(k) Process


So you have an idea to manufacture a new medical combination device. You’re excitement for how it could improve the lives of patients around the world quickly turns to anxiety as you forecast the steps moving from product to production.


FDA regulation when it comes to combination medical devices can be a daunting project to take on. Depending on your specific medical device submission, the Center for Devices and Radiological Health (CDRH) is split between the Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostics and Radiological Health (OIR). Reviewed by the (CDRH), it sometimes takes reverse engineering the entire submission process to fully understand what’s required.


Do What You Do Best:

Before diving into the details, it’s important to remember that a process like the 510(k) is a tedious one requiring a good investment of time and resources. If you’re wanting to stick with what you want to do best, let us help you navigate these waters.


What is a 510(k)?

Straight from the pages of the U.S. Food and Drug Administration (FDA) guidelines: “section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify the FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket notification.” FDA.gov.



While innovation is the life-blood of advances in technology and medicine, the FDA acts as the gatekeeper to market ensuring patient safety. Viewing the process as a partnership makes the journey smoother for everyone rather than viewing it as a road-block. Both parties want to see advances in technology and better patient care.


What is the 510(k) Process?

Great, you understand what a 510(k) is; now how do get started? If you’ve done your homework and followed all testing procedures precisely and accurately, the road to production can be smooth. However, for the inexperienced or first-time 510(k) navigators, the process can be painfully frustrating while also wasting valuable time and resources. The faster to market the better.


Your first gatekeeper is the Center for Biologics Evaluation and Research (CBER). They regulate the medical devices involved in the collection, processing, testing, manufacturing and administration of blood, blood components and cellular products. According to fda.gov, they also regulate all HIV test kits used to screen donor blood, blood component and cellular products.


Before preparing the 510(k) to the FDA, be sure all testing both for safety and compliance have been completed.


Introduction of new technology in the medical device space are typically categorized by the FDA in three ways:

  1. New devices never seen before in the market.
  2. Modifications to existing devices.
  3. It might be that your device is similar to another previously approved by the FDA (predicate device). You can search the FDA 501(k) database to learn more.


Submitting the 510(k):

After submission, you’ll be assigned a 501(k) number, often referred to as the K number. Once you have a K number, you’ve still got a ways to go. The FDA has a goal of reviewing submissions within 90 days, but the average is typically much higher. If you’ve taken the proper steps and prepared well, you should hear back with clearance to move to market. Register your device with the FDA and you’ve just successfully navigated the 510(k) process.


For more information about the 510(k) process as it applies to medical combination devices, please contact us today.




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