New Medical Devices

New Medical Devices

The novel medical devices featured on this page are unique class III medical devices that have received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA). Class II devices that require FDA 510(k) premarket notification clearance are not generally considered to be novel devices because the marketing submission requirement is to show that the device is substantially equivalent to a currently marketed predicate device. One exception where a new class I or II medical device may be considered to be novel is if it was reclassified from class III through the De Novo reclassification request.

Medical device approvals

Medical device approval paths are:

• Pre-market notification, also known as a 510(k)
• Pre-market approval (PMA)
• De Novo product classification request, and
• Humanitarian device exemption (HDA).

Device class and required approvals

Depending on the level of risk their use may present, medical devices either do not need an explicit approval or require one of the three types of Food and Drug Administration (FDA) device approvals. Class I is the lowest device risk classification, and most class I devices, such as tongue depressors, do not require a U.S. marketing application. Product manufacturers do have obligations, however, such as establishment registration and device listings, and a quality system that includes a compliant complaint handling system.

Most class II moderate-risk devices require a premarket notification, or 510(k) submission to demonstrate that the product is substantially equivalent to a predicate device that has been cleared for sale on the U.S. market. A 510(k) submission is required for new devices and significant changes to existing products.

New class III high-risk devices will first require an Investigational Device Exemption (IDE) for a clinical study to show that the device is safe and effective. Then, the manufacturer must submit a voluminous PMA for FDA review and approval.

FDA automatically classifies any new type of medical device that was not on the U.S. market prior to the 1976 Medical Device Amendments (MDA) as a class III device. A De Novo classification request is to ask FDA to review the new device’s characteristics and re-classify it as a class I or class II medical device.

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