FDA will begin accepting nominations for participation in the voluntary MDDT Pilot Program September 15, 2014.
The Food and Drug Administration (FDA) is soliciting proposals to participate in a pilot program for Medical Device Development Tools (MDDT) qualification (MDDT Pilot Program). Under the MDDT Pilot Program, FDA intends to work together with developers of tools that meet the criteria for the proposed program, to determine whether certain tools may be developed and qualified in order to facilitate more predictable, efficient, and transparent regulatory evaluation when MDDTs are used to generate valid scientific evidence for medical device premarket applications. In the Federal Register of November 14, 2013 (78 FR 68459), the Food and Drug Administration (FDA) announced the availability of the draft guidance entitled “Medical Device Development Tools” (MDDT draft guidance). (http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm374427.htm)
When finalized, the draft guidance will represent FDA’s current thinking on qualification of MDDTs for use in device development and evaluation. The proposed MDDT qualification process is intended to support the development of MDDTs—tools that manufacturers and FDA use to assess and measure the performance,safety, and effectiveness of medical devices. MDDT tools qualified by FDA can then be relied upon by the medical device industry in support of their device submissions to the Agency, potentially reducing time and other resources needed to develop new products. This proposed voluntary qualification process is intended to enable submitters of MDDT proposals chosen for this pilot program to work closely with FDA to determine the amount and type of evidence and other information needed to support qualification for a specific tool and context of use.
The anticipated benefits of the proposed MDDT qualification process include facilitating timely development of tools that manufacturers and FDA use to assess and measure the performance, safety, and effectiveness of medical devices. FDA expects that manufacturers can better rely on MDDTs that have been FDA reviewed and accepted (qualified), and made available through this voluntary program, which supports innovative medical device development and promotes regulatory science. The proposed MDDT qualification process supports the FDA’s plan to advance regulatory science—the science of developing new tools, methods and approaches to assess the safety, effectiveness, performance, and quality of medical devices. Advancements in regulatory science help to bridge the gap between research and discovery of medical devices and the actual delivery of the device to patients. The proposed qualification process also supports FDA’s strategic priority of strengthening the clinical trial enterprise by potentially increasing the efficiency of the clinical studies. Finally, this proposed qualification process supports FDA’s strategic priority actions to strike the right balance between premarket and postmarket data collection, leading to earlier access to beneficial innovative technologies for patients in the United States. For example, an MDDT qualified for use as an intermediate or surrogate endpoint could facilitate more efficient development and evaluation of devices, especially for those intended to address unmet medical needs.
Source: Federal Register
