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Human Subjects Division (HSD)

Regulatory Updates

FDA Announces Final Guidance on FDA Decisions for Investigational Device Exemption (IDE) Clinical Investgations

Aug 19, 2014 at 12:00am

The Food and Drug Administration (FDA) has recently issued a final guidance document, “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.” The FDA is committed to improving US patient access to new devices by strengthening and streamlining the clinical trial enterprise so that clinical trials are conducted in the US in an efficient, cost-effective manner while maintaining appropriate patient protections. 

The final guidance describes the FDA’s decision-making and communications regarding applications from companies that want to conduct medical device clinical trials in the US. It also describes more flexible options for clinical study approvals that allow clinical studies to begin sooner while ensuring patient protections.

 The final guidance outlines:

 

  • Processes to allow more efficient study enrollment
  •  Provides information regarding the FDA’s decision-making processes to improve predictability of the regulatory process
  • Introduces communication intended to improve the transparency of FDA’s decision-making process