FDA Medical Device Registration
In the United States, the Food and Drug Administration (FDA) regulates medical devices to make sure the devices are safe and effective. The Center for Devices and Radiological Health (CDRH) is part of the FDA and oversees this program.
The FDA has a necessarily specific, if somewhat complicated, definition for a medical device. According to the FDA, a medical device is an instrument, machine, implant, or other apparatus intended to diagnose or cure a disease or other condition in humans or animals, which is meant to affect the structure or function of the body and which does not rely on a chemical action or upon being metabolized within the body.
There are over 6,000 types of medical devices regulated by CDRH, ranging from simple tongue depressors and hospital gowns to complex programmable pacemakers and robotic surgical systems. If you’re not sure if your device is considered a medical device by the FDA, you can use the information found here to help you make that determination.
Owners or operators of places of businesses that make or distribute medical devices are required to register each year with the FDA. Most of these businesses are also required to list the devices that are made there and the activities that are performed on those devices.
The registration and listing requirements provide the FDA with the location of businesses that make or sell medical devices and with the devices manufactured or sold at those establishments. Knowing where devices are made increases the nation’s ability to prepare for and respond to public health emergencies.
The first step in registering a medical device is to determine how the FDA classifies your device. Medical devices are classified into three categories—Class I, II, and III—based on the risks associated with the device.
Class I devices have the least associated risk and Class III devices have the most. As you might expect, Class I devices have fewer regulations than Class III devices. You can examine the FDA classifications for various devices using the three-letter Product Code, the seven-digit Regulation Number, relevant search terms, or by how the device is used.
The next step is to complete the application process and all the documentation required. This will vary depending on the class of the device. Some devices will require clinical trials, and there are typically fees associated with the application process.
Many devices will require the additional step of submitting a 510(k) application. Once you have submitted the 510(k) application, the FDA has 90 days to survey it, and they may request additional information from you during this time. If a product is cleared, the FDA will mail you a letter with an assigned 510(k) number. Receiving the letter means, essentially, that your device has been cleared and can be sold in the United States.
Once you have finished the FDA medical device approval process and have received your FDA 510(k) clearance letter, the last step is to finish the FDA device listing and establishment registration using the online FDA Unified Registration and Listing Systems (FURLS) on the FDA website.