As announced in the August 15 Federal Register, FDA is soliciting proposals for participation in a pilot program called the “Medical Device Development Tools” Pilot Program” (MDDT). FDA supports the development of MDDTs so that manufacturers and FDA will be able to assess and measure the performance, safety and effectiveness of medical devices.
MDDTs qualified by FDA can then be relied upon by the medical device industry to support their device submissions to the agency. To be an appropriate candidate for the MDDT Pilot Program, the tools must fit into one of the categories such as Clinical Outcome Assessments, Biomarker Tests, and/or Nonclinical Assessment Models.
The tools can address public health needs, the tools potential impact, scope of impact, the tools readiness, the tool’s use, timeline submission for a qualification package, and the potential for impact on public health.
Due to FDA resources, FDA intends to limit the MDDT Pilot Program to no more than 15 candidates. FDA will begin accepting nominations for participation in the voluntary MDDT Pilot Program September 15, 2014. Proposals can be submitted to MDDT@fda.hhs.gov.
Go to www.gpo.gov/fdsys/browse/collection.action?collectionCode=FR to view the notice. For further information, email Kathryn O’Callaghan at Kathryn.ocallaghan@fda.hhs.gov.