In July 2019, Ed Margerrison and Hilda Scharen of CDRH released information on FDA Voices about how the agency is working to increase the pace of medical device innovation. By using sound science and proven methodologies, FDA plans to work with device manufacturers to get beneficial products to market faster.
One of the approaches FDA is taking in these efforts is CDRH’s Medical Device Development Tools (MDDT) program. MDDT seeks to identify and qualify tools that medical device manufacturers can use during development. However, because it’s still a relatively young program and only a handful of tools have been qualified thus far, some organizations might be hesitant to implement these tools or submit ones for qualification. To understand the program and how your medical device organization can work with it, there are a few important facts to take into account.
1. Qualified MDDTs are backed by data
FDA will not approve just any MDDT; there has to be reliable scientific evidence that the tool works as intended within the context of use specified. It must produce measurements that the agency deems as “scientifically plausible.”
2. Context of use is critical
The context in which a given MDDT is meant to operate in is critical to both its qualification and its use within your development activities. Examples of context include the product area the tool is used for, the role it plays, and the phase that leverages it. If your organization expects to make use of an MDDT, understanding the context in which it is qualified for influences how you use it.
3. They can be used in clinical and nonclinical assessments
The MDDT program qualifies tools for both clinical outcome assessments and nonclinical assessment models (apart from biomarker tests). Clinical tools may involve patient-reported information, for example. In fact, the first two MDDTs qualified through the program were questionnaires. On the nonclinical side, the program examines tools that measure or predict device performance on an organism—human or otherwise.
4. FDA considers impact and risk-benefit of MDDTs
Besides context of use, FDA looks at the impact an MDDT can have on public health and the advantages and disadvantages of the tool. Regardless of whether the data supports the tool’s measurements as scientifically plausible, the agency wants to address the broader implications of approving an MDDT. While they want to reduce burden on manufacturers and to speed discoveries, FDA needs to ensure safety and effectiveness over the long term.
5. MDDT qualification is multifaceted
The MDDT program is envisioned as having multiple effects on both regulatory actions and industry development activities. According to FDA guidance on MDDT, tool qualification is aimed at bolstering predictability during product evaluation and regulatory decision-making processes. Approved tools, when appropriately used, provide reviewers with good evidence from a previously validated source. This can shorten review times and confirm the integrity of your product data. Likewise, having qualified MDDTs encourages adoption of scientifically proven tools across the industry.
6. FDA will work with industry in developing MDDTs
The qualification process is pretty straightforward, but FDA is not intent on rejecting all tools that fail to fulfill the MDDT requirements. In the event a proposed tool has a potential to affect public health more significantly than others, FDA will offer an optional incubator phase to the submitters. Through this phase, the agency works with submitters to further develop the tool, gather more supporting evidence, and work toward getting it aligned with the MDDT requirements.
