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Compliance In Focus
Posted by John Lehmann on Tue, Dec 6, 2011

FDA Issues Two Draft Guidance Documents

On November 10th, a FDA press release announced they issued a draft guidance aimed at fostering early-stage devices within the U.S.  The guidance contains new approaches toward early feasibility studies, which are conducted in a small number of patients early in device development, while providing appropriate human subject protection.  The FDA is seeking a small number of companies that could pilot the new approach, as the results of the pilot will help inform the final guidance.

The FDA also issued a guidance regarding clinical trials and medical devices. It outlines the FDA’s process for approving applications from companies that want to conduct medical device trials. Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health indicates "Today's guidance documents give sponsors and FDA device reviewers more flexibility to start investigational studies sooner while maintaining appropriate human subject protection, and they propose efficient ways to support product or study design changes once the study begins."

The draft guidance "FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations" clarifies the FDA's process for approving clinical trial of medical devices and includes:

  • When the FDA might allow patients to enroll in a study while issues are resolved, an approach called "approval with conditions." Appropriate issues might include data analysis methods that can be resolved prior to gathering the data or minor divergences from study endpoints or study design assumptions.
  • When the FDA might allow studies to begin with a smaller group of subjects while companies gather additional data, prior to the larger general enrollment, an approach called "staged approval."

Do you feel these draft guidance documents will help facilitate investigational medical devices studies in humans? Share your thoughts with us.

Topics: Medical Devices, john lehmann, FDA, Clinical Research


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