Qualifying Medical Device Development Tools: FDA Finalizes 2013 Guidance
The US Food and Drug Administration (FDA) on Wednesday finalized guidance first drafted in 2013 to formalize a program that qualifies medical device development tools (MDDT) for use in device development and evaluation programs.
Background
The MDDT program, which FDA’s Center for Devices and Radiological Health launched as a pilot in 2014, is a voluntary process intended to reduce regulatory burden for developers and FDA reviewers through the qualification of tools that can aid in the development and evaluation of medical devices.
“Qualification means that the FDA has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically-plausible measurements and works as intended within the specified context of use,” the agency said.
Once an MDDT is submitted in accordance with the FDA guidance, "Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff," and qualified for a specific context of use, it can be used by any device sponsor for that context of use.
Vextec’s virtual life management for certification was one of the MDDTs accepted into the pilot.
Guidance
FDA has defined three categories of MDDT:
- Clinical outcome assessment: measures of how a patient feels or functions, which could include patient-reported, observer-reported or clinician-reported rating scales, like the NIH stroke scale, or performance outcome measures, such as measures of gait speed or memory recall.
- Biomarker test: a lab test or instrument used to detect or measure an indicator of biologic processes or pharmacologic responses to a treatment, such as tests used as an aid in diagnosis, for patient selection or as clinical study endpoints, including instruments or methods for measuring blood pressure or certain concentrations of serum proteins.
- Nonclinical assessment model: a nonclinical test method or model, such as models used to measure a parameter of interest or to substitute for another generally accepted test or measurement, such as computer modeling to assess conditions typically evaluated through human, animal or bench testing to evaluate a device instead of collecting data from human subjects.
When determining whether to qualify a proposed MDDT, the guidance, which explains each of these elements at length, says CDRH will consider if the MDDT is adequately described, if the proposed context of use is adequately and appropriately defined, what kind of impact the tool might have on public health, if scientific evidence demonstrates that the MDDT reliably and accurately measures what is intended and whether the advantages outweigh potential disadvantages of making decisions based on measurements obtained using the MDDT.
The guidance also discusses other regulatory considerations, such as what happens if an MDDT meets the definition of a device, how to use MDDTs in clinical trials and the various phases of the voluntary qualification process.
FDA will also hold a webinar to further explain the final guidance on 24 August.
Webinar - CDRH Final Guidance: Qualification of Medical Device Development Tools - August 24, 2017