In December 2021, RQM+ acquired AcKnowledge Regulatory Strategies (AcKnowledge RS), a San Diego-based firm specializing in regulatory affairs consulting for the medical device and IVD industry. The integration of this impressive team enhances the extensive RQM+ network of current and former FDA reviewers, scientists, engineers and regulatory and quality experts, and adds additional expertise with FDA submissions. The author of this post is a member of this team, which has done significant work with novel and/or high-risk devices focusing on pre-submissions, 510(k)s, IDEs, PMAs, De Novos, Breakthrough Designation Requests and Safer Technology Program Requests. 

Last week, we mentioned a program called the Breakthrough Devices Program in our blog post about a quick, non-invasive test that could help diagnose the degree of a brain injury. The post from Monday has generated many emails and questions regarding the Breakthrough Devices Program, and today, we are here to settle the seas and answer some questions in order to better educate our readers about what this program really is!

The Breakthrough Devices Program— established under the 21st Century Cures Act in 2016— is a program in which devices with innovative and breakthrough technologies for life-threatening and irreversibly debilitating diseases are approved. These devices that get approved through this program are great for two different reasons: they either offer solutions for diseases for which no approved or cleared treatments exist, or they provide significant advantages over treatments that are already pre-existing.

The Breakthrough Devices Program is an expansion of the Expedited Access Pathways (EAP), a program for devices that are subject to Premarket Approval applications (PMAs), 510(k) premarket notifications, or De Novo designation. The Breakthrough Devices Program is intended to help patients get timely access to breakthrough technologies by reducing the time and money to develop and market these devices. In that sense, this program is intended to help both the patients and the device manufacturers. Just think of the program as a catalyst of sorts, or— in the most basic sense— like getting upgraded to business class on a long flight; the devices that get approved/cleared/granted through the program get extra attention and may receive a decision quickly in order to get them to the patients in a more timely matter.

The program is a non-User Fee (this means it’s free!), voluntary program in which the device sponsor can contact FDA during early phases of the device development to help with a device study plan. The Breakthrough Devices program helps sponsor with an interactive, priority review involving senior management and a case manager. The early interaction helps the sponsor develop an efficient study plan to evaluate devices with complex technologies.

For a device to be considered “breakthrough”, the following criteria should be met:

  1. It should provide a more effective treatment or diagnosis for a life-threatening or irreversibly debilitating human disease or conditions.


The device should meet at least one of the following four conditions:

  1. It should represent a breakthrough technology;

  2. There should be no approved or cleared alternatives existing for the device;

  3. The device should offer advantages over existing devices including the potential to reduce or eliminate the need for hospitalization, improve patient’s quality of life, facilitate patients' ability to manage self-care or establish long-term clinical efficiencies; or

  4. The availability of which is in the best interest of patients.

Sponsors intending to use this program should submit a Pre-Submission for an EAP designation. Unless there is insufficient information, FDA grants EAP designation within 30 days of receipt of a request. The EAP designation, however, can be revoked if the device no longer meets the criteria outlined by the EAP guidance document or if any untrue or false documents were submitted in support of the request. Also, just because you think your device is breakthrough doesn't always make it so.

Keep in mind that FDA might not agree with your request, though that shouldn't be a reason to despair! We hear this has happened to a few companies who intend to submit a traditional premarket notification. (Remember, the whole premise behind the 510(k) program is 'demonstrating substantial equivalence' to a device that's already on the market. This might be hard to reconcile with the criteria listed above.) 

FDA grants the EAP designation based on benefit-risk determinations. If the device provides considerable benefit to patients with a life-threatening disease when no alternative treatments are available, then FDA grants the EAP designation if adequate post market controls are in place.

Ever since the establishment of the program, 54 devices have been granted breakthrough status through the Breakthrough Devices Program. Many of these devices have progressed to become extremely effective mechanisms that are highly exalted. One such device that has attained much success is the Orion Cortical Visual Prosthesis System from Second Sight Medical Products Inc., a brain implant that is targeted towards blind people who have damage to their optic nerve. The device mimics light perception and transmits signals to an implant that is situated in the patient’s visual cortex, a truly remarkable development in the medical and optic world.  

Overall, the Breakthrough Devices Program, as developed by the FDA, promises to have the patient’s interest as the foremost concern, without compromising on the safety and effectiveness. While it might not be a good fit for all devices (i.e. if your device isn't breakthrough, or you're all ready to submit and the review of your request may delay your submission), we think this program is a potential win/win/win situation for FDA, industry, and patients!

Further Reading:

  1. Draft Guidance for Industry and FDA Staff

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