[ARTICLE] FDA Breakthrough Devices Program (BDP) and Safer Technologies Program (STeP) for Medical Devices

Launched in 2016, the FDA Breakthrough Devices program (BDP) is intended to provide patients with more rapid access to medical devices that are foreseen to enable a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.
 
The new FDA Safer Technology Program (STeP) which is operational since March 2021, aims to accelerate patient access to medical devices that are expected to improve the safety of treatments targeting diseases that are less serious than those qualifying for the existing BDP.
 
A BDP or STeP designation for a device notably allows companies to benefit from additional FDA input, flexibility with regards to clinical study design and quality system and manufacturing information requirements, and prioritized review during the premarket phase; and can therefore considerably diminish the time necessary for US market approval.
 
This article will review the principles, features, requirements, application processes, and benefits, of both programs.
 
 

The Breakthrough Devices Program (BDP)

The FDA Breakthrough Devices Program (BDP) is a voluntary program intended to ensure patients with timely access to certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is available for devices and device-led combination products subject to review under a premarket approval notification (PMA), premarket notification (510(k)), or De Novo classification request (“De Novo Request”).
 
Companies designated for the BDP benefit from additional feedbacks from the FDA during the premarket phase, although the designation does not change the statutory standards for PMA, 510(k) clearance, or De Novo marketing authorization. The Breakthrough Devices Program replaced the previous Expedited Access Pathway (EAP) and Priority Review for medical devices.
 
The FDA has issued a guidance document on the Breakthrough Devices Program that provides detailed information on the program principle, on the procedure for designation request, and on the program features.
 
Devices are eligible for breakthrough device designation if both of the following criteria are met:

• The first criterion is that the device provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions.
•  The second criterion is that the device also meets at least one of the following:

 
a) Represents breakthrough technology
 
b) No approved or cleared alternatives exist
 
c) Offers significant advantages over existing approved or cleared alternatives
 
d) Device availability is in the best interest of patients
 
When a device is granted the Breakthrough Device Designation, the manufacturer is ensured direct interactive communication with a sufficient number of well-trained FDA staff, including senior management, with expertise in the application of the BDP.
 
Interaction with the FDA to obtain feedback on the device development is managed through a variety of options, including “sprint” discussions (i.e. discussions with the goal of reaching mutual agreement on a specific topic within a set time frame (e.g. 45 days)), request for discussion on a Data Development Plan, and request for discussion to reach clinical protocol agreement.
 
With regards to the last aforementioned point, the FDA will take steps to ensure that the design of clinical trials is as efficient and flexible as practicable. It will, for instance, allow the study design to be adapted during the clinical study and/or approval process.
 
Moreover, the FDA may allow for part of non-clinical and clinical data to be collected in the post-market phase, provided there are no major safety concerns. In addition, with the BDP designation there is also a prioritized review of regulatory submissions, including Q-Submissions, Investigational Device Exemption (IDE) applications, and marketing submissions.
 
Finally, for PMA submissions that typically require a preapproval inspection, the FDA intends to expedite the review of manufacturing and quality system compliance for BDP-designated devices.
 
If the manufacturer can show compliance with the statutory and regulatory requirements by other means than submitting the all the items listed in the FDA guidance “Quality System Information for Certain Premarket Application reviews”, the FDA may accept less quality and manufacturing information. This may occur for instance when the manufacturer has a good track record for quality system compliance and that no new manufacturing issues that could negatively affect product quality or performance are identified. In appropriate cases, the FDA may decide it is acceptable to conduct the inspection of the manufacturing sites after the device has been approved through the BDP.

How to apply for the Breakthrough Devices Program?

To apply for the BDP program, manufacturers shall submit a special Q submission named “Designation Request for Breakthrough Device”. The submission should provide information to describe the device, the indications for use, regulatory history, and it should explain in details the rationale why the device meets the requirements to be eligible for the program. If other requests for FDA feedback are concomitantly pending, manufacturers should consider submitting them after the FDA renders the BDP designation decision as a BDP designation may affect the feedback that FDA provides on the other requests.
 
The FDA will issue a decision on the BDP designation within a maximum of 60 calendar days, and request any additional information it may require within 30 days. The BDP designation request typically takes the form of an approximately 30 page submission file and usually requires a few weeks for preparation, if necessary with the support of a consulting firm.
 
Despite a report that the FDA may be open to making public devices having received BDP designations in the future, the decision to do so remains for the moment at the discretion of the manufacturers participating in the program.
 
It is therefore difficult to obtain reliable data on how frequently BDP designations are solicited and granted. Nonetheless, according to an article published in May 2020 by MedTech Dive who was able to obtain data relating BDP designations from the FDA, there were 11 devices awarded with a BDP designation in 2016, 19 in 2017, and 55 in 2018, 136 in 2019 and 50 and in 2020 as of May.
 
Thus, the BDP program is increasingly gaining popularity, showing roughly a two-fold increase in BDP designations per year since the launch of the program in 2016. Of these, five BDP-designated devices received full marketing authorization in 2019 (three PMAs, one 510(k), and one De Novo).
 
No information regarding the number of devices that won final marketing authorizations under the program in 2020 could be retrieved. Nonetheless, this number is expected to increase proportionally to the number of granted designations.
 
 

The Safer Technology Program (STeP)

The new Safer Technology Program (STeP) for Medical Devices was designed as a complement to the BDP. The STeP is highly similar to the latter, but tailored for medical devices and device-led combination products that are reasonably expected to significantly improve the safety of treatments targeting an underlying disease or condition less serious than those qualifying for the BDP.
 
These may include for example devices intended to treat or diagnose non-life-threatening or reversible conditions. As for the BDP, STeP is also available for devices and device-led combination products subject to review under a premarket approval notification (PMA), premarket notification (510(k)), or De Novo classification request (“De Novo Request”). The FDA issued the final guidance on the Safer Technologies Program on January 6th 2021, and anticipated accepting program entrance requests as of March 8th, 2021.
 
For a device to be eligible for STeP designation, it should meet the following criteria:

• The first criterion is that the device should not be eligible for the Breakthrough Devices Program (BDP) in reason of the less serious nature of the disease or condition treated, diagnosed, or prevented by the device; and
• The second criterion is that the device should be reasonably expected to significantly improve the benefit-risk profile of a treatment of diagnostic by means of substantial safety innovations that provide for at least one of the following:

 
a) A reduction in the occurrence of a known serious adverse event,
 
b) A reduction in the occurrence of a known device failure mode,
 
c) A reduction in the occurrence of a known use-related hazard or use error, or
 
d) An improvement in the safety of another device or intervention
 
Similarly to a BDP designation request, manufacturers should apply for a STeP designation by submitting a Q-Submission requesting inclusion in the STeP program. This request should be highlighted in the accompanying cover letter. The request should provide information to describe the device, the expected safety improvement, the indications for use, regulatory history, and justification as to why the device meets the specific STeP eligibility factors.
 
More information on the contents of a Q-Submission Request for inclusion in STeP may be found in appendix I of the STeP final guidance. Once the program will be operational, the FDA intends to request any additional information it may require on the request for inclusion in STeP within 30 calendar days, and to issue its final decision within 60 days.
 
Once a device is designated for the Safer Technology Program, the manufacturer can choose to interact with the FDA through the same options as for the BDP, including interactive and timely discussions with FDA staff, senior management engagement, early engagement on Data Development Plans, and sprint discussions. Similarly as within the BDP program, the FDA will also allow for a certain degree of flexibility on clinical trial design and for the collection of non-clinical and clinical data.
 
In appropriate cases, the FDA also intends to expedite the review of manufacturing and quality system compliance for STeP designated devices by demanding less quality system and manufacturing information, or waiving the requirement for a preapproval inspection of the manufacturing sites.
 
As the STeP program is not yet operational at the time of writing this article, no data is currently available regarding the number of STeP designations and approvals.
 
In summary, the FDA Breakthrough Devices and Safety Technology Programs provide considerable advantages that can significantly reduce the time for US market access for devices fulfilling either set of specific inclusion criteria described above. It shall be emphasized that the BDP and STeP programs are complementary and will run in parallel. The BDP addresses devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, whereas the STeP is intended for devices expected to increase the safety of treatments or diagnosis of less serious diseases. Once designated for either of the programs, the manufacturer can expect interactive and timely interaction with the FDA, senior FDA management engagement, priority review, and flexibility with regards to the pre/postmarket balance of data collection, clinical study design, and quality and manufacturing information requirements.
 
 

How Medidee can help

Does your medical device potentially meet the criteria for inclusion in the BDP or STeP programs? Our dedicated US market specialists at Medidee are well-experienced with the Breakthrough Devices Program, and may assist you determining whether your product qualifies for inclusion in the BDP or STeP programs, in preparing and submitting your BDP or STeP designation request, and in subsequent interactions with the FDA once the designation is granted. Contact us now!

This article was written by Dr Jérôme Randall.