The U.S. Food and Drug Administration (FDA) Breakthrough Devices Program, introduced in December 2016, was designed to provide patients and healthcare providers with timely access to medical devices that deliver effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Specifically, the program was introduced to speed the development, assessment and review of these device types while preserving the statutory standards for Pre-Market approval (PMA), 510(k) clearance and De Novo marketing authorization.
To date, the Breakthrough Devices Program has been extremely encouraging, with many medical products receiving the special attention they require to speed delivery of innovative technologies and improve patient healthcare in a more immediate manner.
In step with the Breakthrough Devices Program, and the Agency’s promise to introduce additional programs that promote earlier access to life-changing devices, the U.S. FDA introduced the Safer Technologies Program (“STeP”) on January 6, 2021.
The FDA’s latest program is intended for 510(k), De Novo or PMA devices that do not meet Breakthrough Devices Program criteria, but still have an important role in the treatment of lesser life-threatening or debilitating diseases/conditions and bring significant benefits to patients. Benefit examples include reducing a known side effect, adverse event, failure mode, or otherwise improve the technology of a device to improve overall patient safety.
The STeP Program benefits are also similar in nature to that of the Breakthrough Devices Program, including:
- Sprint Conversations: Single topic conversations with a dedicated review team
- Data Development Plan: An optional plan to layout deliverables and timelines required for a product to reach commercialization
- Pre-Submissions: Pre-Submission application to the agency for feedback; this is in consultation with a Sponsor’s internal team and agreement upon a timeline for feedback
- Status Updates: Regulatory planned updates between the Sponsor and FDA allow the Agency to discuss general progress and allows the Sponsor to provide the FDA with a high-level review of potential issues to address in sprint conversations or pre-submission meetings
Sponsors interested in applying to the STeP Program will do so in a similar fashion as necessitated by the Breakthrough Devices Program. A Pre-Submission application is required, which requests inclusion into the program. However, one significant point of difference is that a Pre-Submission request can occur in tandem with a regulatory submission of a Sponsor’s 510(k), De Novo or PMA application (or during a Sponsor’s review). Note: The STeP Program’s Pre-Submission content is similar in structure to that of the Breakthrough Devices Program, as outlined in the appendix of the FDA’s new guidance.
The FDA is expected to review all STeP applications within 60 days of receipt, with interactive questions and answers anticipated approximately 30 days after receipt. While this recent guidance states that the Agency will not accept STeP pre-submissions until March 6, 2021, it is anticipated that the program will quickly ramp up to bring beneficial devices the attention they deserve in the coming months.
In conclusion, STeP is yet another delivery mechanism to assist Sponsors with the opportunity to bring innovative, life-changing devices to commercialization earlier, and for those that have a significant benefit over existing technologies.
How can NAMSA Help?
Navigating the U.S. FDA regulatory landscape can be overwhelming for any medical device manufacturer – not to mention very cost-intensive. That’s why having the right partner, at the right time, can be invaluable in achieving regulatory requirements, market success and accelerated timelines.
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the FDA. In fact, our internal teams of medical device development experts communicate with the FDA nearly every day. From Pre-Submission meetings – to Pre-IDE preparation – and FDA inspection preparation, our teams are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers. This expertise has been proven to save medical device organizations up to $17M in costs and 23 months in development timelines.
If you are interested in speaking with us about FDA-related activities or other global regulatory strategies, please contact us at: https://www.namsa.com/contact-us.
Angela Mallery EdD, has over 25 years of experience working in device regulatory affairs in small, medium and large sized companies. Angela is a project manager and regulatory consultant for NAMSA on worldwide device regulatory registrations; including cardiac and peripheral devices, tissue products and urology devices. She also holds an adjunct faculty position at St. Cloud State University, teaching in the regulatory program.