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
On September 4, 2014 the FDA will hold a webinar to explain the guidance and to provide a forum for asking questions you may have. Registration is not necessary.
Webinar Details:
Date: Thursday, September 4, 2014
Time: 1:00 PM – 2:30 PM, Eastern Time
To ensure you are connected, log-in by 12:45 PM.
To hear the presentation and ask questions:
Dial: 888-972-7807; passcode: 1405152
To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join/
Conference number: PW8306690
Passcode: CDRH
Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/Training/CDRHLearn/default.htm
Please Note: the slide presentation will also be available at this site on the morning of the webinar.
If you have any questions regarding this guidance, please contact Owen Faris, Clinical Trials Director (acting) at owen.faris@fda.hhs.gov, or the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2041, 301-796-7100 or dice@fda.hhs.gov.
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