FDA Seeks Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens

Summary

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. The FDA is seeking guidance on informed consent for in vitro diagnostic device studies using leftover human specimens that are not identifiable.