Introduction
With changing technology, there are more innovative medical devices than ever before. These devices present additional and unique challenges to bring them to market. For certain devices that offer better safety profiles for treatment and diagnosis than what’s currently available, the FDA’s Safer Technologies Program provides an opportunity for the sponsor to benefit from a process that facilitates communication and interaction to work towards a timely marketing authorization.
Main Point
The Safer Technologies Program is one of the programs offered by FDA which can provide an opportunity to reduce risks in submissions for qualifying devices. This white paper describes the program and overall process–as well as how a sponsor would request inclusion into the program–and the advantages of this route as a strategy to pursue U.S. marketing authorization for those products.
Background
In a previous MEDIcept white paper, you were introduced to the FDA CDRH’s Breakthrough Devices Program, which is intended to offer a faster road through the premarket notification, approval, or De Novo process for certain innovative medical devices and device-led combination products intended to treat serious (life-threatening) or irreversible diseases or conditions. However, there are many lower risk devices that are ineligible for the Breakthrough Program but could benefit from a similar program.
Also an outcome of the 21st Century Cures Act (Public Law 114-255), the FDA’s Safer Technologies Program, (STeP) is modeled after the Breakthrough Program, but intended for certain innovative products that treat or diagnose less serious health threats or reversible illnesses or conditions. Note that this isn’t just for new products but can also include modifications to existing devices. STeP is also voluntary and in itself it is not a regulatory pathway, but rather a process allowing sponsors to engage early and more often with CDRH for devices subject to the PMA, De Novo, or 510(k) pathways and that meet the criteria, or “eligibility factors” to be included in the program. While it’s possible to submit a request for inclusion in STeP either concurrent with or after sending in a marketing, submission, many of the advantages of STeP would be lost. The most program benefit is gained by starting early in the development cycle.
Details of Solution
Like the Breakthrough Devices Program, STeP is intended to provide more opportunities for collaboration and communication between the sponsor and FDA than is typically available. To do this, CDRH leverages their Q-Submission Program for requesting feedback and meetings for submissions. But the first step is to determine if a device qualifies.
Eligibility is determined using two types of factors: the general eligibility factor and specific eligibility factor. For the general eligibility factor, the expected regulatory pathway for the device or device-led combination product should be a 510(k), De Novo request, or a PMA.
Next, the device needs to meet several specific eligibility factors. The device should not be intended for treating or diagnosing life-threatening or serious irreversible diseases and conditions; in other words, the device should not be eligible for the Breakthrough Devices Program. STeP is intended for devices that treat less serious or reversible illnesses and conditions.
The other specific eligibility factor revolves around safety as follows:
- The device is reasonably expected to significantly improve the benefit-risk profile of treatment or diagnosis through substantial safety innovations that reduce the risk in use of the device by one or more of the following:
- Reduction in occurrence of a known serious adverse event, and/or;
- Reduction in occurrence of a known device failure mode, and/or;
- Reduction in occurrence of a known use-related hazard or use error, and or;
- Improvement in the safety of another device or intervention.
If the sponsor determines that the device is a good fit for STeP, then it’s time to prepare for the two phases for the program. The first step is to formally request inclusion in STeP, and the second is comprised of activities that facilitate device development as well as the review of any regulatory submissions. The goals of this second step are achievable through frequent and planned communication with the FDA. By design, reviews are interactive, and the responsiveness of the sponsor should at least equal that of FDA.
First, to request inclusion in STeP, the sponsor should prepare and submit a Q-Submission. Suggested content for the STeP request is similar to other Q-Submissions, including:
- Background information:
- Device description
- Expected safety improvement
- Indications for Use
- Regulatory history
It is also advised to explain the justification for meeting the STeP eligibility factors. For the general eligibility factor, discuss what type of marketing submission is planned (510(k), De Novo, or PMA). It is worth noting though, that the FDA does not make a determination on the regulatory pathway as a part of this Q-Submission.
For the specific eligibility factors, discuss which of the sub-parts are met by the device. Usually complete clinical study data is not expected in the Q-Submission. Note that this Q-Submission should only be a STeP entrance request; any other questions should not be submitted together with the request.
The FDA’s goal is to make a decision regarding inclusion in STeP within 60 calendar days of receipt of the request. FDA may come back with a request for more information during this time, within 30 days of receipt, It is important be aware of the additional information request does not put the review clock on hold. If the FDA does not receive the additional information in a timely manner, this may lead to the denial of the inclusion request.
If your device is accepted into STeP, the FDA offers the sponsor a couple of choices for more detailed feedback and interaction during device development. These are completely optional, and you can pursue one or both options―sprint discussions, and review of your Data Development Plan (DDP), if you have one.
A sprint discussion is an interaction with the FDA to reach an agreement on a particular topic related to non-clinical or clinical evaluation. A DDP is a high-level document that outlines data collection planning over the product lifecycle, and may include clinical evaluation strategy and/or non-clinical testing plan. Here, the value of getting FDA input early is considerable and should reduce premarket submission issues down the road.
Regular pre-submissions covering more general, higher-level topics can still be utilized even if participating in STeP. An advantage here is that the timeline for feedback in a traditional pre-submission can be faster than usual by specifying that the device is included in STeP. Another opportunity for interaction covering higher-level aspects is in the form of regular status updates—meetings that can cover topics such overall project timeframes, identifying potential hurdles, and plans for future discussions.
While the advantages of STeP are many, there are some time-related risks which a sponsor should be aware of. For instance, getting FDA feedback for a combination product will likely take more time, because multiple centers are involved. Also, FDA will prioritize its resources to support the Breakthrough Devices Program over STeP, as the former is mandated by law. Most of the features of STeP come with the caveat from FDA that they are available “as resources permit.” However, with actions like the development of these types of programs, the FDA continues to demonstrate that safety and innovation are important priorities for the agency.
And finally, the sponsor can choose and request to withdraw from STeP at any point during the process.
Business Advantage
A device’s inclusion in STeP and the sponsor going through this process are advantageous from several standpoints. Although the program doesn’t reduce the regulatory burden, it does reduce the regulatory risks that would be encountered by going straight to a premarket submission. This is especially true in the case where it is expected that clinical data will need to be submitted. Also, a device accepted into STeP essentially has external validation that it is innovative and would fill an important gap in the market. As many such products are created by start-ups, this process can help a team demonstrate to VCs and other investors early on that they can execute on regulatory strategy.
Conclusion
For companies that have a medical device in the early stages of development that falls short of qualifying for the FDA’s Breakthrough Technologies Program, it’s worth considering the Safer Technologies Program. STeP facilitates interaction and collaboration between the sponsor and FDA throughout product development leading to a marketing submission. Early and frequent feedback through sprint discussions as well as the chance to obtain agreement on clinical and non-clinical testing offers a valuable opportunity to reduce regulatory risk.
