510(k) or PMA? – How to know which pathway is best for your device in the USA
Companies interested in distributing a medical device in the USA for the first time are likely to have some questions regarding the process. The FDA has several types of premarket applications that allow legal market access for devices to the USA. The following article provides a high-level overview of the two most common applications, highlighting when each type is most likely to be used.
Which pathway should be used?
The FDA has classified around 1700 different types of generic devices (classes I to III), based on the level of risk they present to patients. Most class I devices (e.g. elastic bandages and tongue compressors) are exempt from pre-market clearance or approval, though other requirements, such as establishment registration and device listing, still apply. Most Class II devices (e.g. powered wheelchairs and medication infusion pumps) require submission of a 510(k) Premarket Notification, and most class III devices (e.g. pacemakers and heart valves) require submission of a Premarket Approval (PMA) application. Although other FDA premarket application types exist, the 510(k) and PMA applications are the most common submission pathways taken by industry.
A 510(k) can be submitted for new devices or for certain changes to existing devices, including changes to the intended use, contraindications, and operation mechanism. The purpose of a 510(k) submission is to show that the device to be marketed (the “subject device”) is at least as safe and effective as another, similar device already legally marketed in the United States (the “predicate device”.) In a 510(k) submission, applicants compare subject and predicate devices, providing evidence of substantial equivalence, and explaining why any differences between the two are acceptable. Substantial equivalence can usually be demonstrated with laboratory testing (e.g. bench and animal testing) and generally does not require human clinical trial data, but the final decision is made at the discretion of the FDA. A device gains market “clearance” by the FDA through the 510(k) process.
The PMA pathway is the most stringent of all device application types due to the level of risk associated with class III devices. A PMA application requires applicants to prove that the subject device is safe and effective for human use. In addition to laboratory testing, human clinical trial data is also usually required. A device gains market “approval” by the FDA through the PMA process.
If you are a medical device manufacturer, importer, or brand owner interested in selling a device in the United States, contact us today to learn how we can help by determining the appropriate FDA classification for your device, evaluating suitability of predicate devices, identifying supporting evidence requirements, and preparing and compiling your submission package to the FDA.