All companies planning to sell a medical device in the United States need to register their product with the US FDA. Most Class I devices can be self-registered but most Class II devices require a 510(k) submission. For Class III devices, a Pre-Market (PMA) submission is needed. The steps below provide a brief overview of how the PMA and the FDA 510(k) process work. The chart shown illustrates the FDA approval process in USA and is available for download in PDF format. However, if you would like to explain the steps to someone else in an email, you can cut and paste the text below or send them a link to this page.
The US FDA medical device approval process explained
Using the FDA classification database, determine the classification of your device by researching “Predicate Devices” already registered in the US market. Pay special attention to the three letter Product Code and seven digit Regulation Number associated with the predicate devices you identify. If no predicate found, use 513(g) or De Novo process. US FDA device classification is made up of Class I, Class II and Class III.
Implement Quality Management System (QMS) which meets the FDA Quality System Regulation (QSR) found in 21 CFR Part 820. This is also commonly known as FDA Good Manufacturing Practice (GMP).
Innovative Class II, and all Class III, devices will likely require clinical studies. Get “Pre-Submission (Pre-Sub)” feedback from the FDA.
If clinical studies will be required, apply for an Investigational Device Exemption (IDE). Develop clinical trial protocol and conduct studies. *
For Class II devices, prepare and submit 510(k) Premarket Notification application. Pay 510(k) or PMA submission fee. For Class III devices, prepare* and submit Premarket Approval (PMA) application. Pay PMA submission fee to FDA.
For Class III devices, FDA conducts facility inspections of all major suppliers involved in the design and production of your device. All parties must be compliant with FDA QSR.
For Class II devices, the FDA issues 510(k) clearance letter and posts it online. For Class III devices, the FDA issues PMA approval letter and posts it online.
At this time, you must be in full compliance with QSRs. The FDA will not inspect Class I or II device manufacturers for compliance prior to device registration but does conduct random inspections and can issue a Form 483 for non-compliance..
If you have no local presence in the US, appoint an FDA US Agent representative as a local point of contact with the FDA..
List your device and register your company using FURLS system on the FDA website in accordance with 21 CFR Part 807; contract manufacturers and sterilizers must also register and list. Specify your appointed US Agent. Your FDA Establishment Registration and Listing must be renewed on a yearly basis.
You are now able to sell your device in the US. The FDA listing on their website will serve as your authorization to commercialize your device in the US. This authorization does not expire as long as certain types of changes are not made, e.g., design, intended use.
* The process of supplying clinical study data in support of a PMA submission is far more complex than presented in this chart. This is an extremely simplified and high level view of the FDA requirements regarding clinical study data.
Information current as of: 11/09/2014