With its Safer Technologies Program (STeP), the FDA hopes to open up a new approval pathway for manufacturers of innovative medical devices. The FDA wants patients to benefit more quickly from these innovations.
In this article, you can read about the simplifications and help the FDA intends to provide for you as a manufacturer and what requirements you must meet to market your device more quickly and easily on the American market through the “Safer Technologies Program”.
1. What is the Safer Technologies Program for Medical Devices?
With the Safer Technologies Program (STeP), the FDA is aiming to provide an additional approval procedure for medical devices. Under certain conditions, it will provide an alternative to the classic approval procedures, in particular:
The FDA wants to give patients faster access to new technologies and devices. With the “Breakthrough Devices Program”, it has already launched one expedited approval procedure. Now it wants to create something comparable with the “Safer Technologies Program”.
However, unlike the Breakthrough Program, the Safer Technologies Program is intended for devices that diagnose or treat less serious diseases and injuries, for example, non-life-threatening or reversible diseases.
c) Principles of the Safer Technologies Program
The Safer Technologies Program is characterized by the following principles:
- Interactive and timely communication.
- The FDA involving teams of experts, including senior management.
- Applications being processed with high priority.
- The FDA again making its decisions based on the benefit-risk profile. These are decisions such as whether the device can be included in the STeP or which clinical data has to be collected before and after the device is marketed.
- It should be possible to efficiently and flexibly plan, redesign and conduct clinical studies.
This procedure reminds of us agile plans. THE FDA even talks of “sprint discussions”. More on that later.
2. Safer Technology Program (STeP) process
The manufacturer should request inclusion in the Safer Technologies Program via a Q-submission. This application should contain the following information:
- Background information
- Description of the device, incl. functionality, pictures, drawings
- Expected safety improvement
- Intended purpose
- History of previous interactions with the FDA, e.g. other applications
- Reason why the device can be included in the STeP. This includes, in particular, the procedure that would otherwise have to be followed, and a reason why the device cannot be included in the Breakthrough Program.
- A precise description of how the device improves the benefit-risk profile. This should be one of the factors listed in the “Improvements” section.
b) Communication and interaction with the FDA
If approved, the FDA offers several options for interaction:
- Sprint Discussions
These discussions aim to respond to a specific issue within a set time period. It wants to offer more frequent and timely meetings and responses to a manufacturer's questions.
- Data Development Plan
The manufacturer submits this plan, in which it explains which clinical and non-clinical data it wants to collect, as well as when and how it wants to collect this data. The FDA offers to evaluate this plan in a similar way to the sprint discussions.
- Other “Pre-Submissions”
If the manufacturer wants to discuss a broader scope of topics than would be possible with the options listed above, the FDA will consider other pre-submissions. However, this depends on the availability of the FDA’s staff.
- Status Updates
The FDA may also agree to give the manufacturer regular status updates (it gives the example of bimonthly) outside of the above options. However, these cannot be used to for official feedback.
3. What does the FDA's Safer Technologies Program offer you?
The STeP appears attractive for several reasons:
- Faster approval
The approval can be issued quicker. The FDA gives high priority to the application. It wants to make a decision within 60 days.
- Lower costs through targeted management
The manufacturer finds out more quickly and during the procedure the views and concerns of the FDA and can respond to them in the course of the procedure.
The FDA intends to respond to questions within 30 days.
Both these things will speed the process up and help avoid unnecessary costs.
4. What is the program for? What requirements have to be met?
Manufacturers can consider participating in the Safer Technologies Program if they meet the following conditions:
a) Formal and organizational requirements
- The application can be submitted no earlier than 60 days after September 19, 2019
- The device is not intended for patients with severe, particularly life-threatening or potentially irreversible, diseases and injuries.
- The device would normally have to undergo a PMA, a de novo or 510(k) process, but not a breakthrough process.
- The manufacturer must be willing to respond to FDA requests quickly and to work closely with the agency.
- It must inform the FDA of its plans at a very early stage, i.e., during development.
b) Device requirements
The device must be innovative in that it improves the risk-benefit profile compared to its alternatives by
- Reducing serious side effects
- Reducing (device) errors
- Reducing use errors of use that can lead to hazards or
- Increasing the safety of another device or procedure. By this the FDA means accessories.
Although the FDA talks about an improvement to the benefit-risk profile, most of the improvements it lists are improvements resulting from the reduction of risks and not the improvement of benefits. This also explains the name of the program: Safer Technologies Program.
The STeP is aimed less at modified devices.
The FDA continues to provide patients with quicker access to novel medical devices through more agile and “risk-based” approval procedures. The Breakthrough Medical Devices Program and the Precert Program are further evidence of these efforts.
The name Safer Technologies Program describes the objective of the program perfectly: It is about safer technologies and, therefore, about improving the benefit-risk profile by reducing risks.
The FDA is, therefore, also likely to strengthen the alternatives, such as the STeP and Breakthrough Program, in order to increasingly replace the 510(k) program, which is criticized by the FDA itself. John Oliver has very pointedly detailed why this program is open to criticism.
Video: John Oliver points out the weaknesses of the US approval system - including the 510(k) procedure.