FDA Early Feasibility Study (EFS) guidance intended to spur US-based device innovation

When reviewing chapter 5.3 Clinical Strategy, readers may be interested in accessing the FDA’s guidance on “Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.” The agency released this guidance in October 2013 in an effort to improve early patient access to beneficial medical devices. The initiative also seeks to maintain/regain US leadership in the medical technology by reducing the barriers and unpredictability associated with launching early device feasibility studies in the country.

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