US FDA Registration Process for Medical Devices and IVDs

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All companies planning to sell a medical device or IVD 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 & IVD approval process explained

Step 1
Determine the classification of your medical device or in vitro diagnostic (IVD) device by searching the FDA classification database using relevant search terms, or by identifying another (predicate) device with the same intended use and technology. Pay special attention to the three-letter Product Code and seven-digit Regulation Number associated with the predicate devices you identify. If the classification cannot be determined, use the 513(g) process to request classification from the FDA.

Step 2
Some Class I* devices are exempt from most QSR requirements, with exceptions.** For Class II* and III devices, implement Quality Management System (QMS) that meets the FDA Quality System Regulation (QSR) found in 21 CFR Part 820.

Step 3
Innovative Class II and all Class III devices will likely require clinical studies. Get “Pre-Submission (Pre-Sub)” feedback from the FDA.

Step 4
If clinical studies will be required, apply for an Investigational Device Exemption (IDE). Develop clinical trial protocol and conduct study.*** Non-significant risk studies may be performed with IRB approval.

Step 5
For Class II devices, prepare and submit 510(k) Premarket Notification application and pay related fee. For Class III devices, prepare*** and submit Premarket Approval (PMA) application. Pay PMA submission fee.

Step 6
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.

Step 7
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.

Step 8
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 once registered, the FDA may conduct random inspections and can issue a Form 483 for non-compliance.

Step 9
If you have no local presence in the US, appoint an FDA US Agent representative as a local point of contact with the FDA.

Step 10
List your device and register your company using FURLS system on the FDA website; pay fees for Establishment Registration and Listing, which must be renewed each year.

Step 11
You are now able to sell your device in the US. Your company and device registration status will be listed on the FDA website. Your authorization does not expire as long as no changes are made to the device design, intended use, etc.

 

* Devices with a new intended use or novel technology are automatically placed into Class III by the FDA. A novel device that is shown not to be high risk may be reviewed and placed on the market as a Class I or II under a De Novo Classification submission. This chart does not depict the De Novo process.

** Class I devices that are exempt from FDA QSR implementation must still comply with certain portions of FDA 21 CFR Part 820, including requirements for record keeping (21 CFR 820.180) and complaint file (21 CFR 820.198).

*** The process of supplying clinical study data in support of an FDA submission is far more complex than presented in this chart. This is a simplified and high-level overview of FDA registration requirements.

Information current as of: 08/2019