FDA Breakthrough Device Program

The FDA has published current success figures as statistics for its "Breakthrough Devices Program". What is the current status?

The aim of the "Breakthrough Devices Program" is to provide patients and healthcare providers with timely access to certain medical devices (life-saving and those intended to treat serious conditions). To this end, the development, evaluation, and testing for premarket approval, 510(k) clearance, and De-Novo marketing authorization are accelerated. Under this program, medical device manufacturers can contact the FDA experts to obtain feedback on product development, receive assistance with applying for market approval by the FDA, and to achieve priority review of marketing applications. The program also applies to certain combination products, is voluntary, and is also set out in a guideline.

The document also refers to an alternative to the "Breakthrough Device Program", the "Safer Technologies Program for Medical Devices".

The "Safer Technologies Program (SteP) for Medical Devices"

If a medical device under development does not meet the requirements to participate in the "Breakthrough Device Program", the "Safer Technologies Program (SteP) for Medical Devices" is recommended as an alternative. This is also a voluntary program that can be used in the development of medical devices, combination products, and IVDs that involve a significant improvement in product safety. The aim here is also to reduce development times and achieve market approval more quickly. Similar to the "Breakthrough Device Program", the FDA also offers assistance with this program in the form of timely discussions with feedback.

Statistics on the "Breakthrough Device Program"

But now to the statistics: How many breakthrough products have been accepted by the FDA? The evaluation is carried out on a fiscal year basis.

Starting with fiscal year 2015 (11 approvals), recognition has been steadily increasing. From 2018 (55 approvals) onwards, the figures are at a high level, ranging from 110 approvals in fiscal year 2020 to 165 for fiscal year 2024. Even for 2025, 125 approvals have already been granted by the end of June 2025.

It is also interesting to see the "indications" for which breakthrough devices are to be used. Cardiovascular diseases are by far in first place (243), followed by neurology (189) and orthopedics (161).

And how many Breakthrough Medical Devices have ultimately received approval? With an extensive list of 160 products (156 CDRH, 4 CBER), the overview on the website ends with references to accompanying guidelines and contact options.

Further information on the "Breakthrough Device Program" is available on a separate website at CDRH.