The second step would be to determine if an appropriate product classification exists for your product.
There are 3 regulatory classes of medical devices in the U.S. Each of them are linked to requirements (called Regulatory Controls) and regulated by the FDA’s Center for Devices and Radiological Health (CDRH).
1. Class I General Controls (low risk medical device)
- With Exemptions
- Without Exemptions
2. Class II General Controls and Special Controls (moderate risk medical device)
- With Exemptions
- Without Exemptions
3. Class III General Controls and Premarket Approval (high risk medical device)
The classification determines whether a submission is required and/or which type of submission is appropriate. It also determines the type of regulatory control necessary for ensuring safety and effectiveness (S&E) (S&E is based on the level of risk of the medical device).
An important point for the classification of the device is to take into account its intended use and its indication for use and similar products already approved or cleared in the U.S. market.
Determine the classification of your device
To determine if an appropriate product classification exists for your product, the FDA recommends different methods:
Method 1: Search the Product Classification Database
Go to the Product Classification Database and try to determine if there is an existing product classification that applies to your product. Search by keyword(s) , product code, regulation number, or device class.
Method 2: Search for Similar Devices
Try to identify a similar device legally marketed in the United States. Then, go to the databases below and search for it FDA letter or order that permits market authorization. The information in the letter will help you determine the classification of your device.
This database includes devices with Premarket Approval, and includes the approval order, Summary of Safety and Effectiveness, and labeling for the approved device (original PMAs and panel-track supplements).
This database includes releasable 510(k) information.
This database includes De Novo classification orders and transparency summaries.
This database includes devices with HDE approval, and includes the approval order, Summary of Safety and Probable Benefit, and labeling for the approved device.
Important Note: Most Class I and some Class II devices may not be listed in the databases referenced above because they are exempt and do not require the FDA’s review before marketing.
Method 3: Search for Similar Devices by Device Listing
Try to identify a similar device legally marketed in the United States. Then, go to the FDA’s Establishment Registration and Device Listing database, and review the device listing information.
Method 4: The Device Panel
As described by the FDA, If you know the Device Classification Panel (medical specialty) to which your device belongs you would be able to find the device classification.
Go to the listing for that panel in the Product Classification Database and identify your device and the corresponding regulation. Most of the time the device classification is mentioned.
If the device classification is not mentioned, go directly to the CFR and find the classification for your device by reading through the list of classified devices.
Each classification panel in the CFR begins with a list of devices classified in that panel.
Each classified device has a 7-digit number associated with it (e.g., 21 CFR 880.2920 – Clinical Mercury Thermometer).
Once you find your device in the panel’s beginning list, go to the section indicated: in this example, 21 CFR 880.2920 .
In this example, the panel’s beginning list describes the device and says it is Class II.
Similarly, in the Product Classification Database under “thermometer”, you’ll see several entries for various types of thermometers.
The three letter product code, FLK in the database for Clinical Mercury Thermometer, is also the classification number which is used on the Medical Device Listing form.
Unable to make a device determination for your product?
If you are unable to make a device determination for your product after following the methods above, the FDA recommends to contact the Division of Industry and Consumer Education (DICE).
Then, if you are still unable to make a device determination for your product, the FDA recommends to contact the Device Determination mailbox at DeviceDetermination@fda.hhs.gov. You will need to provide the following in your email: Intended Use, physical description and mechanism of action, any claims you intend to publicly make about the product and your contact information.
The 513(g) Request
The 513(g) Request is a formal process for information regarding the device determination or classification and the regulatory requirements, from the FDA, that may be applicable to a particular device.
FDA Guidance document: FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act Guidance (2012).