All companies planning to sell a medical or in vitro diagnostic (IVD) device in the United States (U.S.) need to register their products with the U.S. Food and Drug Administration (FDA). Most low-risk devices do not require premarket review. Most medium- and all high-risk devices require either premarket clearance or approval prior to reaching the market.
Overview: US FDA medical and IVD device approval process
The chart illustrates the FDA approval process per device classification in the U.S. and is available for download in the Regulatory Affairs Management Suite (RAMS). Only a simplified overview of the main steps for registration is provided here.
Determine the classification of your device by searching the FDA classification database.
Depending on your device classification, establish a quality management system (QMS) according to the FDA Quality System Regulation (QSR) requirements, as applicable.
Based on the device classification, prepare and submit a 510(k) application or a premarket approval (PMA) application and pay the relevant application fee.
For high-risk devices, the FDA conducts facility inspections of the manufacturer and all major suppliers involved in the design and production of the device. All parties must comply with the FDA QSR.
The FDA reviews the application and may request additional information. Upon approval, the FDA issues the 510(k) clearance letter or PMA approval letter.
If you have no local presence in the U.S., appoint a U.S. Agent as a local point of contact with the FDA.
List your device and register your company using the FDA Unified Registration and Listing System (FURLS) on the FDA website and pay the relevant fees for establishment registration and device listing.
Download: 510k process flowchart
This is a condensed version of the steps outlined in the chart and only addresses the primary registration pathway in the market. You can obtain a detailed process chart and market reports for the United States when you create your complementary Regulatory Affairs Management Suite (RAMS) account. Get your first chart for free when you create a RAMS account.