FDA Submits Collection of Information for OMB Review Under Paperwork Reduction Act

Summary

The Food and Drug Administration (FDA) has submitted a proposed collection of information to the Office of Management and Budget (OMB) for review and clearance, as required by the Paperwork Reduction Act of 1995, in order to implement a pilot program for submitting voluntary audit reports for medical devices in compliance with the ISO 13485:2003 standard.