Learn · free, no account

The Breakthrough Devices Program

Draft, not yet reviewed by a regulatory professional. Written from FDA's published guidance, which is cited below; read the guidance itself before you rely on any of it.

The Breakthrough Devices Program speeds development and review for devices that could meaningfully improve care for serious conditions. It brings prioritised review and more interaction with FDA, not a lower evidence standard.

The two criteria

First, the device provides more effective treatment or diagnosis of a life-threatening or irreversibly debilitating human disease or condition.

Second, at least one of:

it represents breakthrough technology;
no approved or cleared alternatives exist;
it offers significant advantages over existing approved or cleared alternatives;
its availability is in the best interest of patients.

How to ask

A designation request is a Q-Submission sent before your marketing submission. FDA aims to decide within 60 days. There is no user fee for the request. Designation applies whichever route follows: PMA, De Novo or 510(k).

What it brings

Options such as sprint discussions and data-development plan agreements, senior management involvement, and priority review of the eventual submission. The submission still has to meet its normal standard.

Try the Breakthrough check.

Sources

General information, not regulatory advice. FDA decides every classification and submission; confirm your route with FDA (a Pre-Sub or a 513(g)) or a qualified regulatory professional. Fees and review goals are planning figures; check FDA's current schedule.

More: Choosing an FDA pathway · Traditional, Special or Abbreviated 510(k) · De Novo in plain terms · 513(g) requests in plain terms · Pre-Subs (Q-Submissions) in plain terms ·