Premarket Notification (510(k))

There are three types of 510(k)s: Traditional, Special, and Abbreviated.

Traditional 510(k):

The Traditional 510(k) may used for any original 510(k) or for a modification to a previously cleared device under 510(k).

Special 510(k):

The Special 510(k) is used for device modifications and utilizes the design controls aspect of the Quality System (QS) regulation (21 CFR 820.30).

Abbreviated 510(k):

Device manufacturers may choose to submit an Abbreviated 510(k) when:

a guidance documents exists,
a special control has been established, or
FDA has recognized a relevant consensus standard.

Follow the guidance here to identify the most relevant 510(k) route to approval. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080189.pdf

510(k) Content

The 510(k) submission contains all of the information necessary to allow the FDA to make a decision on the safety and efficacy of a non-exempt Class I and all Class II medical devices. A detailed description of 510(k) content can be found on the FDA/CDRH website at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm084365.htm

510(k) Approval Process

Devices are subject to 510(k) premarket review unless exempt or required to go through the PMA process. Specifically, the 510(k) process, established in 1976, requires a device manufacturer to notify FDA 90 days before it intends to market a device and to establish that the device is substantially equivalent to a legally marketed device that does not require a PMA. The legally marketed device is referred to as a predicate device. Under federal regulations, a predicate device can be a device that

was legally marketed prior to May 28, 1976, for which a PMA is not required; or
was marketed on or after May 28, 1976, and was found to be substantially equivalent to a legally marketed device through the 510(k) process; or
was reclassified by FDA from class III to class II or I.

FDA reviews each 510(k) submission to determine whether the device in question is SE or NSE to a predicate device. To be SE, a device must (1) have the same intended use as the predicate device and (2) have the same technological characteristics as the predicate device or have different technological characteristics and submitted information demonstrates that the device is as safe and effective as the marketed device and does not raise different questions of safety or effectiveness. If the FDA concludes Substantial Equivalence, they will issue an order granting 510(k) clearance allowing immediate introduction of the medical device into commerce.

Further information on 510(k) regulation is available at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm

fda

Research by Eliza Brannigan & Kristin Stiner