FDA Updates List of Approved Medical Device Development Tools
(Thursday, December 1, 2022)
It is not widely known that FDA publishes on its website a list of qualified tools that developers of medical devices can use to generate supporting information for their market approval applications. These tools have been vetted by FDA as “well-defined and reliable measure of a specific concept” and hence interpretations of benefits based on these tools increase the odds of the successful approval by FDA. The Medical Device Development Tools (MDDT) site lists tools intended for the evaluation of a wide range of medical devices and include biomarker tests, clinician-reported outcome measures, patient-reported outcome measures, animal or computational models, and sensors or wearables that can be used to understand how a given medical device works, in terms of safety, effectiveness, and other aspects of performance. Three kinds of tools may be used for medical devices. For devices intended for therapeutic applications, clinical outcome measures or COAs are employed to assess the risks and benefits of the device in development. COAs could be based on patient-reported, physician-reported, or observer-reported performance assessments. There are 6 COAs listed by FDA on its MDDTs site. There is one biomarker-based tool listed for use by developers of medical devices to prevent or treat acute head trauma such as concussions. The third kind of MDDTs are non-clinical assessment tools, of which there are 5 tools, that are based on computational models or non-clinical tests. The MDDTs are a limited list of tools vetted by FDA and the intent of publishing them is to encourage developers to propose additional tools that may be standards for all. One can submit a proposal for a new MDDT on FDA’s website and then have a series of discussions to refine the tool based on FDA’s feedback. It seems that the benefit for a tool developer to be listed on FDA’s website is to be recognized for developing a given new tool, and possibly play a role as advisor or contractor for medical device manufacturers intending to use their tool. Currently, the list is short and covers about 10 kinds of devices; hopefully, it will grow over time.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC