FDAnews Device Daily Bulletin

FDA APPROVES INFORMED CONSENT DOCUMENT

March 28, 2006
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The FDA announced that a collection of information entitled ''Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens That are Not Individually Identifiable,'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The proposed information collection had been submitted to OMB for review and clearance, The OMB approved the information collection and has assigned an OMB control number to it The approval expires on September 30, 2006.

A copy of the supporting statement for this information collection is available at http://www.fda.gov/ohrms/dockets (http://www.fda.gov/ohrms/dockets).