Premarket Notification: 510(k) FDA

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed medical device (21 CFR 807.92(a)(3)) that is not subject to PMA.1

 

The key elements that the FDA uses to evaluate substantial equivalence are:

• Same intended use as the predicate device
• Same technological characteristics as the predicate device
• At least as safe and effective as predicate device

RQM+ Lab Services can assist you in the testing and submission of your 510(k), as well as answering the following questions about your device from the FDA’s guidance document.

• Do the devices have the same technological characteristics?
• Do the different technological characteristics of the devices raise different questions of safety and effectiveness?
• Are the methods acceptable?
• Does the data demonstrate substantial equivalence?

For more information on the 510(k) process, read the FDA’s guidance document here.

Some of the techniques that RQM+ Lab Services deploys in the testing to support a 510(k) include:

 

¹https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketnotification510k/