Does your product require a FDA 510(k) application?

The United States Food, Drug and Cosmetic Act contains Section 510(k). Section 510(k) requires medical device manufacturers to register with the US Food and Drug Administration (FDA) and inform the FDA of their intent to market a medical device at least 90 days in advance. The 510(k) submission allows the FDA to determine whether your device is "substantially equivalent" to a similar device already on the market.

Who must submit a 510k Premarket Notification application?

Generally, manufacturers/importers of some Class 1 and Class 3, and most Class 2 medical devices, are required to file a 510k with the FDA. This includes:

1. Medical device manufacturers or importers/exporters wishing to introduce a new medical device to the US market if a "Predicate" device already exists.
2. Specification developers that design a device and have it manufactured by another company for eventual sale in the US.
3. Companies that are proposing a significantly different design or different Intended Use for a product that is already sold in the US.
4. Repackagers or relabelers of devices.

Who does NOT need to submit a 510k Premarket Notification?

Generally, you do not need to file a FDA 510k application if you:

• Manufacture/import a Class 1 medical device that does not fall into the "reserved*" category (about 25% fall into this category)
• Manufacture an unregulated component.

How to determine whether YOUR medical device requires a 510k submission

We've created a simple 7 step guide to help you determine if your medical device requires a 510k submission.