Feb 10, 2012
New informed consent requirements for some medical device clinical trials in the US will go into effect March 7, 2012.
The rules will require some clinical trial sponsors and investigators to include statements in their Informed Consent documents that clinical trial data will be entered into a database available via the website Investigational Device Exemptions (IDE).
The onus is on sponsors and investigators to determine whether their clinical trials must comply with the new rules. Applicable clinical trials initiated on or after March 7, 2012 must comply with these requirements.
According to 21 CFR 50.25(c), Informed Consent documents for clinical trials falling under the new rule must include the following statement verbatim:
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.
Medical device clinical trials specifically excluded from the new Informed Consent rules include small feasibility trials as well as trials for prototype devices with primary measures of feasibility.
Update 12/20/2011: According to Emergo Group sources in Beijing, the waiver policy was instituted by the Beijing FDA (BFDA) rather than the SFDA. Furthermore, the policy applies only to domestic medical devices in China, not imports.
Through new guidance published this month, the US Food and Drug Administration has clarified its review and approval process for its Investigational Device Exemption (IDE) regulations, and has also proposed steps to allow clinical investigations of high-risk medical devices in some instances where IDE approvals have not been finalized.