Pilot Program for Early Feasibility Study Investigational Device Exemption Applications
Health and Human Services Department, Food and Drug Administration
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Key Details
- Posted Date
- NAICS Code
- 621999
- Source
- Federal Register
- Contract Type
- regulation
Description
The Food and Drug Administration (FDA) is soliciting nominations from sponsors of innovative device technologies to participate in a pilot program for early feasibility study investigational device exemption (IDE) applications. The pilot program will conform to the approaches outlined in the draft guidance entitled "Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies." Under the pilot program, FDA's review of IDE applications for an early feasibility study, including a first in human study, is expected to be based on less nonclinical data than would be expected for a traditional feasibility or a pivotal study. The pilot will also involve new approaches to IDE review to facilitate timely device and clinical protocol modifications during an early feasibility study.
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