In the August 15, 2014, Federal Register, FDA requested nominations for interested tool developers to participate in its Medical Device Development Tools ("MDDT") Pilot Program. In November 2013, FDA issued a draft guidance, Medical Device Development Tools, outlining the proposed voluntary process for qualification of MDDT for use in device development and evaluation programs. An MDDT is a scientifically validated tool (e.g., clinical outcome assessment, biomarker test, or nonclinical assessment model or method) that aids device development and regulatory approval. The MDDT Pilot Program will allow FDA to work with qualifying tool developers to determine whether such 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. MDDT qualified by FDA can 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. The Notice provides information on the guiding principles of the MDDT Pilot Program, appropriate candidates, and procedures for assessing candidates. There are no fees associated with submitting a tool for qualification. The MDDT Pilot Program is limited to approximately 15 candidates. FDA intends to accept requests for participation in the MDDT Pilot Program until such time that the MDDT draft guidance is finalized. For information about how to submit an MDDT qualification package, visit the MDDT webpage. Nominations accepted starting September 15, 2014.
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