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US FDA Proposes Updates to Breakthrough Devices Program Guidance

The US FDA has issued draft guidance on select updates for the Breakthrough Devices Program guidance, expanding its scope to devices that will improve accessibility.

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December 5, 2022

The US Food and Drug Administration has issued a draft guidance document on the proposed select updates for the Breakthrough Devices Program guidance, expanding its scope to devices that will improve accessibility and promote health equity once finalized.

Specifically, the draft guidance clarifies the considerations in designating devices, including devices that may benefit populations impacted by disparities in health and healthcare. The document also includes discussions how the FDA intends to disclose the Breakthrough Device status once the device obtains marketing authorization for an indication for use consistent with its Breakthrough Device designation.

Facilitating more timely access to breakthrough devices

The FDA has finalized the guidance document​ on the Breakthrough Devices Program, an expedited pathway to regulatory compliance intended for devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. This program is designed to help patients have more timely access to such devices by expediting device development, assessment, and review, while preserving the statutory standards for PMA, 510(k) clearance, and De Novo authorization.

The draft guidance document details criteria for eligibility and designation, program features, and the process for Breakthrough Device designation​, and provides an example application as well.

For example, as part of the FDA’s assessment to determine whether a device “is reasonably expected to be more effective, we consider if it is designed to address a pathophysiological or clinical characteristic associated with certain populations that could have a clinically meaningful impact for treatment or diagnosis of the condition in those populations,” according to the FDA.

The document is available for comment for 60 days from the October 21, 2022 date of publication.


Emergo by UL will continue to post updates to FDA guidance as they become available.


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