By Mark Durivage, Quality Systems Compliance LLC
The FDA’s Center for Devices and Radiological Health (CDRH) released the Safer Technologies Program for Medical Devices (STeP) Guidance for Industry and Food and Drug Administration Staff on January 6, 2021, with plans to begin accepting applications for STeP beginning March 8, 2021. The two-month delay is due to the expected time to “operationalize” the program, which is a voluntary program applicable to “certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated with morbidities and mortalities less serious than those eligible for the Breakthrough Devices Program.”
There are two considerations for device eligibility into the STeP. The first requires interested sponsors to formally request inclusion in the STeP through a Q-submission (Requests for Feedback and Meetings for Medical Device Submissions). The second considers how the device in the STeP “is expected to improve the risk-benefit profile of a treatment or diagnostic compared to known alternatives for the identified disease or condition, as well as the significance of the expected improvement.”
In the final guidance, the FDA reaffirms its belief that STeP “will help patients have more timely access to these medical devices and device-led combination products by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance.”
Updates From The Proposed Guidance
The draft guidance, which I covered here on Med Device Online on October 2, 2019, received 15 public comments. Most of the FDA’s changes from the proposed draft were minimal, but two items stand out. The first notable change pertains to the 60-calendar-day timeline to include or deny inclusion in the STeP. The FDA clarified that additional requests for information will not “stop” the 60-calendar-day timeline. If the requests for information are delayed or do not provide appropriate justification, the result may be denial of the request for inclusion in the STeP.
The second change was in the FDA’s philosophy regarding status updates. The FDA now believes that regular status updates provide an opportunity for a high-level view of the project and identification of potential hurdles, while a sprint discussion, data development plan, or traditional pre-submission provides the opportunity for detailed feedback to address specific sponsor goals.
STeP Factor I: Subject To Marketing Authorization Via The Pre-Market Approval (PMA), De Novo Request, Or 510(k) Pathways
Your Q-submission should include the following sections:
- Device Description: Describe and provide an overview of the device or device-led combination product and its principles of operation; include applicable engineering drawings and specifications.
- Expected Safety Improvement: Describe safety issue(s) that the device or device-led combination product addresses, rationale for the seriousness of adverse events associated with the safety issue, and any technological advances or features of the device intended to improve safety.
- Indications for Use: Explain the device’s indications for use and any specific claims related to safety improvement.
- Planned Marketing Submission: Describe the organization’s planned regulatory submission pathway: Pre-Market Approval (PMA), De Novo request, or 510(k).
STeP Factor II: Ineligible for the Breakthrough Devices Program
Your device or combination product should be reasonably expected to significantly improve the risk-benefit profile of a treatment or diagnostic through substantial safety innovations that provide for at least one of the following:
- A reduction in the occurrence of a known serious adverse event, including significantly reducing or eliminating infections associated with death, life-threatening conditions, or permanent disability; or significantly reducing or eliminating debilitating symptoms that manifest after device implantation. Consideration of these reductions include a time period shortly after treatment or diagnosis (days to months), as well as reductions associated with long-term adverse outcomes, occurring months to years following treatment or diagnosis.
- A reduction in the occurrence of a known device failure mode that results in serious adverse health consequences, including those that result in death, are life-threatening, or involve permanent or long-term injuries to patients.
- A reduction in the occurrence of a known use-related hazard or use error. The device or device-led combination product should be safe and effective for its intended use(s), condition(s) of use, use-related hazards, and resultant use errors. Additionally, hazards inherent in the device design will be considered.
- An improvement in the safety of another device or intervention. Does the device or device-led combination product offer an improved safety benefit for another medical device or intervention?
The FDA plans to expedite review of devices that have the potential to significantly improve safety. The STeP fosters collaboration between the FDA and the sponsor to define an efficient device development path toward obtaining the appropriate FDA marketing authorization. However, the FDA plans to prioritize resources for the Breakthrough Devices Program over the STeP because the Breakthrough Devices Program is statutorily mandated.
Other principles guiding the STeP program include:
- Interactive and timely communication between the FDA and the sponsor
- Review team support ensures the reviewers apply novel approaches to regulatory and device development challenges
- Prioritized review of regulatory submissions
- Risk-benefit assessments and pre-/postmarket balance of data collection, considering the totality of evidence regarding the extent of the device’s probable benefits and probable risks, including the extent of uncertainty in the risk-benefit information
- Efficient and flexible clinical study design, considering proposals incorporating real-world data sources that may be used to support the proposed indication and/or labeling
- Manufacturing considerations for PMA submissions through expediting the review of manufacturing and quality systems compliance.
Recent changes in organization, structure, and philosophy at the FDA are a positive sign for the medical device industry, and programs like STeP are encouraging reminders of that fact. Greater industry and agency cooperation with new innovative programs like STeP are ultimately a win for patients, healthcare providers, and medical device companies by improving safety, expediting development, assessment, and review, and ultimately reducing costs and improving patient outcomes. Questions about the STeP program can be directed to SaferTechnologiesProgram@fda.hhs.gov.
About the Author
Mark Allen Durivage has worked as a practitioner, educator, consultant, and author. He is Managing Principal Consultant at Quality Systems Compliance LLC, an ASQ Fellow and SRE Fellow. He earned a BAS in computer aided machining from Siena Heights University and an MS in quality management from Eastern Michigan University. He holds several certifications including CRE, CQE, CQA, CSQP, CSSBB, RAC (Global), and CTBS. He has written several books available through ASQ Quality Press, published articles in Quality Progress, and is a frequent contributor to Life Science Connect. Durivage resides in Lambertville, Michigan. Please feel free to email him with any questions or comments.