is being presented by Cheryl Hill, Regulatory Manager, with Pleiad Inc. and airs on Wednesday, May 2nd, 2012. For more details or to register, please visit our site at www.fxconferences.com
Is the IDE program changing? Over the past 12 months FDA has released several proposed rules, final rules, draft guidances and final guidance documents. Some of these documents have an immediate impact on the IDE program, such as the final rule regarding Informed Consent Elements. This rule mandates that for all applicable device (or drug/biologic) clinical trials, informed consent documents and processes include a specific statement that the clinical trial information will be entered into a databank – with a compliance date of March 2012. Other documents, such as the draft guidance FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations, which explains all possible decision outcomes of an IDE submission, provide insight into the IDE program and Agency expectations.
This audio conference presentation provides an overview of these documents, as our speaker explains their impact on IDE regulations and offers suggestions for compliance.
