It has been a full year since Title VIII of the Food and Drug Administration Amendments Act of 2007 expanded the scope of information that must be registered in ClinicalTrials.gov and mandated the inclusion of medical device trials. Additional new requirements also included increasing the amount of trial information, requiring results, and setting penalties for noncompliance.
One year later, the medical device community still has a lot of questions about its requirements and responsibilities for compliance with Title VIII, and the FDA is still working on providing the answers and guidance. This audio conference looks at the latest information surrounding registration of medical device trials and what you need to do to be in compliance.
Registering Device Trials on ClinicalTrials.gov is presented by Amy Wise, Manager of Clinical Research, of PharmaNet and airs Thursday, Nov. 13, 2008. For more details or to register, please visit our site www.fxconferences.com
