Breakthrough Device Programme of the FDA

Recommendation

2/3 May 2024

Process Validation - Live Online Training

The FDA discusses its "Breakthrough Device Programme" relatively extensively on their website. A total of 14 subsections explain the programme itself, how a "Breakthrough Device" can be recognised, statistical key figures of the "Breakthrough Device Programme", relevant regulations and contact data.

But first, what is a Breakthrough Device Programme?

It is a voluntary programme for certain medical devices and combination products with the goal of providing more effective treatment or diagnostic capabilities for life-threatening or irreversibly debilitating diseases or conditions. The programme aims to provide patients with these diseases and healthcare providers with timely access to such products. To this end, the development, evaluation and review of such products are to be accelerated. However, this is to be done while ensuring patient safety. The programme replaces an older FDA procedure ("Expedited Access Pathway and Priority Review for medical devices").

The advantage for manufacturers is early cooperation with the FDA before marketing and accelerated approval.

On the FDA website you can find more information on the Breakthrough Device Programme.