Understanding FDA 510(k) Process for Medical Devices

Premarket Notification 510(k) process

medicaldevice classification • Regulatory classes were established in 1976 thanks to the Medical Device Amendment. • It defined the degree of control necessary to ensure that the devices are safe and effective. • Classification : • Class 1 : Low-risk devices (general controls) • Class 2 : Moderate-risk devices (general and special controls) • Class 3 : High-risk devices (general controls and premarket approval)

Whatis a 510(k)? • Premarket submission made to the FDA to demonstrate that the device to be marketed is substantially equivalent (SE) to a legally marketed device which is not subject to PreMarket Approval (PMA) .

Substantialequivalence • A device is substantially equivalent if, compared to a predicate, it : • has the same intended use as the predicate; and • has the same technological characteristics as the predicate; or • has the same intended use as the predicate; and • has different technological characteristics and the information submitted to FDA; • does not raise new questions of safety and effectiveness; and • demonstrates that the device is at least as safe and effective as the legally marketed device.

Predicatedevices • Submitters must compare their 510(k) device to a similar legally marketed device. • Any legally U.S. marketed device may be used as a predicate : • A device cleared through the 510(k) process, • A device that was legally marketed prior to May 28, 1976 (preamendment devices), • A device that was originally on the U.S. market as a Class III device (Premarket Approval) and later downclassified to Class II or I.

Whenis a 510(k) required? A new complete 510(k) application is required for : • Introducing a device into commercial distribution for the first time. • Proposing a different intended use for a device which you already have in commercial distribution. • Changes or modifications to an existing device, if the modifications could significantly affect the safety or effectiveness of the device, or if the device is to be marketed for a new or different indication. Examples of modifications that may require a 510(k) : • Sterilizationmethod • Structural material • Manufacturingmethod • Operating parameters or conditions of use • Patients or user safetyfeatures • …

The 510(k) submissionprocess • The SE determination is usually made within 90 days and is made based on the information submitted. • Once the device is determined to be SE, it can then be marketed in the U.S.

The submissionmethods

510(k) reviewfees • The 510(k) Review Fee is the same for Traditional, Special, and Abbreviated 510(k). • Small businesses may qualify for a reduced fee. • Application is considered incomplete if the fee is not paid.

Examples and figures • EOS imaging (November 7th, 2016) for kneeEOS online 3D planning software. • SeaSpine Holdings (November 7th, 2016) for Mariner Posterior Fixation System. • Merit medical systems (November 7th, 2016) for swiftNINJA steerable microcatheter.

Examples and figures

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Understanding FDA 510(k) Process for Medical Devices