De Novo medical devices – FDA has issued two guidance documents

Two new guidance documents on De Novo applications for medical devices, one a draft and the other final guidance, have been issued by the US Food and Drugs Administration (FDA).

De Novo classification, also known as the “Evaluation of Automatic Class III Designation”, allows the FDA to classify new devices that regardless of their risk were automatically classified into Class III, to Class I or II using criteria of Section 513(a)(1)(A-B).

The draft guidance document that outlines the procedures and criteria the FDA use when assessing a De Novo classification request, provides FDA staff with clearer approach to making “Accept” or “Refuse to Accept” (RTA) decisions on De Novo requests for medical devices.

The final guidance document provides information about the process for the submission and review of a De Novo classification request. This process provides a pathway to Class I or Class II classification for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.

The guidance describes two mechanisms for interacting with FDA regarding a device for which De Novo classification may be appropriate: Pre-submission (Pre-sub) and De Novo Request. A Pre-sub is not required in order to obtain FDA review of a De Novo request, but it is useful to obtain early feedback from FDA on whether a device may be eligible for the De Novo classification process, and/or advice on the documentation needed in a subsequent De Novo request.

A De Novo request may be submitted with or without a preceding 510(k). The success of a De Novo request that is filed without a Pre-Sub “will depend more heavily on how well you search for a potential predicate device, identify the risks to health and special controls (if applicable), and provide adequate valid scientific evidence to support granting the De Novo request.”

The final guidance also provides the addresses for the submissions of De Novo requests and recommends content and documents to be included in a De Novo request.

To read both guidance documents in detail, follow the links:

Acceptance Review for De Novo Classification Requests (draft document)

De Novo Classification Process (Evaluation of Automatic Class III Designation) (final guidance)