Yesterday, the U.S. Food and Drug Administration (FDA or the Agency) took a number of steps to “advance medical device innovation and help patients gain faster access to beneficial technologies,” as characterized by FDA Commissioner Scott Gottlieb, M.D. More specifically, the Agency:
- Released two final guidance documents, “Deciding When to Submit a 510(k) for a Change to an Existing Device” (Device Change Guidance) and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device” (Software Change Guidance);
- Released a draft guidance, "Breakthrough Devices Program" (Breakthrough Guidance); and
- Announced that it has qualified the first tool under FDA’s medical device development tools (MDDT) program.
Device Change Final Guidances
As their names suggest, the Device Change Guidance applies to medical device changes broadly, whereas the Software Guidance focuses on software-specific changes and complements the broader Device Change Guidance. The Guidances, drafts of which were released by the Agency on August 8, 2016, provide recommendations to help manufacturers determine when an intended change to a legally-marketed medical device subject to FDA’s premarket notification (i.e., 510(k)) requirements warrants Agency review (e.g., changes that could significantly affect the safety or effectiveness of a device and major changes or modifications to a device’s intended use). The Device Change Guidance supersedes FDA’s previous Guidance on the topic, issued on January 10, 1997.
As compared with the 1997 Guidance, FDA’s recently-released Device Change Guidance includes clarification of significant terminology, explanation of how to use risk assessment to evaluate whether or not a change requires a new 510(k), harmonization of Guidance flowcharts with the text of the document, examples of device changes that would or would not require a new 510(k), and recommendations for documenting decisions about whether or not to submit a new 510(k) for a device change.
On November 16, 2017, at 1:00 p.m. ET, the Agency will hold a webinar to discuss the Device Change Guidance and Software Change Guidance.
Breakthrough Devices Draft Guidance
In the Breakthrough Guidance, FDA sets forth the details of its new “Breakthrough Devices Program” (BDP), which was created by the 21st Century Cures Act, passed by Congress in December 2016. Building on the Expedited Access Pathway (EAP) program, BDP is intended to help patients more quickly access certain devices that more effectively diagnose or treat life-threatening or irreversibly debilitating diseases or conditions. As described in the Breakthrough Guidance, BDP would, among other things, facilitate a quicker pre-submission process for sponsors of breakthrough devices, allowing manufacturers to maximize resources in order to bring novel medical technologies to market faster.
Interested parties should submit comments to FDA on the Breakthrough Guidance by December 26, 2017.
Qualification of First MDDT Program Tool
By way of background, FDA’s MDDT program is a voluntary process intended to reduce regulatory burden for medical device developers and Agency reviewers through the qualification of tools that can aid in the development and evaluation of medical devices. By way of background, in a final guidance issued by FDA in August 2017, the Agency defined three categories of MDDTs:
- Clinical Outcome Assessment: tools that measure how a patient feels or functions – including patient-reported or clinician/observer-reported measures – or performance outcome measures, such as walking speed or memory recall;
- Biomarker Test: a tool (test) used to provide diagnostic, predictive, or safety biomarkers for patient selection or as clinical study endpoints. Examples include blood pressure or an assay that detects a hormone level to determine whether a patient is a safe and appropriate candidate for a clinical trial; and
- Nonclinical Assessment Model: a tool (model or method) that measures or predicts a device function such as a computer model or a material phantom of the heart.
The thought behind the MDDT program is that tools qualified by FDA could be used by industry to support medical device submissions as a way to reduce time and other resources involved in product development. The first such tool, the 23-item Kansas City Cardiomyopathy Questionnaire (KCCQ), can be used to quantify patients’ health status, including the symptoms, physical and social limitations, and impact on quality of life due to heart failure syndrome. While KCCQ is already being used by researchers, clinicians, and device developers, with FDA’s qualification of the tool, now, manufacturers and sponsors will not have to justify their use of the tool within a specific context of use, and Agency review staff can accept the use of the tool without the need to reconfirm its suitability and utility.
FDA hopes that use of MDDTs it qualifies will expedite the regulatory submission and review processes by reducing the number of subjects in clinical trials, saving money, increasing confidence in data quality, and improving review speed and consistency, while maintaining the same level of safety and effectiveness for patients.