Who needs to submit a FDA 510(k) Premarket Notification
The United States Food, Drug and Cosmetic Act contains Section 510(k) which requires medical device manufacturers to register with the US Food and Drug Administration (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 generally equivalent to similar one 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. 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?
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 a component, UNLESS the component is also sold as a replacement part, or is a software product working together with devices.
How to determine the classification of YOUR medical device and whether it needs a 510(k).
1. Visit this section of the FDA website.
2. In the field entitled "DEVICE" type the name of your medical device. Use the broadest term possible. Example: syringe.
3. Most likely, there will be several categories of Class 2 medical devices listed. Click on the one that seems most appropriate for your device. Make note of the three letter PRODUCT CODE.
4. By clicking on the product, you will be taken to another page that provides more details including the classification and whether the product requires a 510(k). Make sure the category you have chosen is appropriate for your product by clicking the REGULATION NUMBER (example: 876.3150).
5. Once you have identified the proper category, go here.
6. Input the three letter PRODUCT CODE into the Product code section.
7. You will now see 510(k) approvals from your competitors listed. Click on their links and read the SUMMARY.
Note that the Summary is exactly that - a summary. To protect the confidentiality of proprietary information, the full Class 2 medical device 510k is not available online. Once you have gone through this exercise, you should know will a fair degree of certainty whether your product requires a 510k. Also, you shoudl read more about the three types of 510(k) applications.
We also offer these services which may interest you:
Medical distributor search for the US, Europe, Japan, Australia or Canada
CE Marking approval for medical devices in Europe
All of our QA and RA consulting services
