ANNOUNCING the FDA Audio Conference: IDEs for Early Feasibility Medical Device Clinical Studies, Including First in Human (FIH) Studies – Wednesday, October 23, 2013 – 1:30 p.m. EST
(Previously scheduled for October 2, 2013)
Date: October 23, 2013
Time: 1:30 PM – 3:00 PM (EST).
To Participate and ask questions: 888-469-0491, passcode: CDRH
To View the Slide Presentation: (available on October 23, 2013) https://www.mymeetings.com/nc/join.php?i=PW5377276&p=CDRH&t=c - Passcode: CDRH
Also at http://www.fda.gov/Training/CDRHLearn/ucm162015.htm#ide.
Following the conference, a transcript, audio recording and slides will be available at http://www.fda.gov/Training/CDRHLearn/ucm162015.htm#ide
On September 30, 2013 (FDA) released a final guidance document, Investigational Device Exemptions (IDEs) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies. This audio conference will provide an opportunity for FDA to further explain this guidance and to answer your questions.
The FDA recognizes the value of encouraging medical device innovation to address clinical needs and improve patient care, particularly when alternative treatments or assessments are unavailable, ineffective or associated with substantial risks to patient safety. This guidance provides new policies that enable device sponsors to move from bench testing to initial clinical studies more quickly, and speed the implementation of product or study design changes once a study begins, while still protecting human subjects.
This guidance outlines new policy regarding the application for and approval of early feasibility study IDEs. Two important elements of the guidance are:
- FDA’s approval of an early feasibility study, including some first-in-human studies, may be based on less nonclinical data than would be expected for other types of studies (e.g., traditional feasibility or pivotal).
- The introduction of new approaches to facilitate timely device and clinical protocol modifications during an early feasibility study, while still maintaining compliance with FDA human subject protection requirements, including obtaining informed consent and Institutional Review Board (IRB) (or ethics committee) oversight.
We look forward to hearing from you during the call on Wednesday. Thank you for your continued support of the FDA and its mission.
Food and Drug Administration
Center for Devices and Radiological Health
Guidance Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM279103.pdf
| This email was sent to kostikblog@ukr.net using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
