The Safer Technologies Program (STeP) is a voluntary program for medical devices and combination products expected to improve the safety of currently available treatments or diagnostics. These are assumed products that target conditions of a less serious nature than those considered for the Breakthrough Devices Program.
The goal of STeP is to provide those in need with access to medical devices by expediting product development and FDA review. However, despite the expediency of the process, this does not reduce the expected standards for premarket approval, 510(k) clearance via a traditional 510(k), or De Novo 510(k) authorization. This means that any organization hoping to take advantage of STeP for their medical device will need a clear idea of the payoff and limitations involved.
The Benefits
- Smarter study design — Early engagement with senior FDA management on data development plans and sprint discussions means better overall design
- Robust pre-market review — Persistent FDA interaction helps efficiently address any topics of concern during the pre-market phase
- Shorter timelines — This level of FDA collaboration reduces your time to marketing authorization
The Most Common Questions
Is my device eligible?
Devices subject to premarket approval applications (PMAs), premarket notification (510(k)), or requests for De Novo 510(k) classification are eligible for inclusion in STeP, so long as both eligibility factors are met:
| CRITERIA | DESCRIPTION | ||
|---|---|---|---|
| First Eligibility Factor | Not eligible for the Breakthrough Devices Program | ||
| Second Eligibility Factor |
Should be reasonably expected to significantly improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations that provide for at least one of the following:
|
When should I submit my request?
My device is eligible, now what? How do I go about submitting my STeP entrance request?
The FDA may identify certain devices as especially good candidates for STeP and recommend they apply for the program. That said, it is often up to the Sponsor.
Sponsors interested in participating in STeP should submit a Q-Submission requesting inclusion in STeP. This request should be the only request in the Q-Submission, and it should be specifically highlighted in the cover letter.
What should I include?
All requests for inclusion of a device in STeP should be sent prior to your marketing submission.
Every STeP request is different. However, there are certain things you must include in every entrance request sent to the FDA:
- Proposed indications for use
- Expected safety improvement
- Regulatory history
- Satisfaction of STeP objectives
- Intended marketing submission
When will I be notified?
The notification process for STeP acceptance is a two-step process:
- If the FDA needs any additional information to complete your submission, you will receive notice within 30 days of submission.
- Within 60 calendar days of submitting your request for inclusion in STeP, you will be notified of the FDA’s final decision.
If I receive approval, what’s next?
- Going forward, you can choose to interact with the FDA to obtain feedback on your device development through a variety of options, including sprint discussions and requests for discussion on a Data Development Plan.
- ▶▶ Learn more about these options in Section V of the Safer Technologies for Medical Devices guidance.
- On top of that, the FDA will also allocate additional resources permit.
When you need to determine the fastest, most effective path to market,
More Safer Technologies Program (STeP) Resources