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# Device Single Audit Program Posts Records Control Document
- URL: https://www.fdaweb.com/device-single-audit-program-posts-records-control-document/
- Published: 2016-07-29T12:00:00.000Z
- Updated: 2026-09-14T21:19:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5136340

CDRH has posted a Medical Device Single Audit Program [document ](http://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM379132.pdf?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)that outlines the control of quality records generated under the pilot program. The pilot is testing the feasibility of conducting a single regulatory audit of a medical device manufacturer’s quality management system that will satisfy the requirements of five regulatory jurisdictions. Audits will be conducted by auditing organizations authorized by the participating regulatory authorities to audit under the program. The pilot will run through December, and then it will be fully implemented sometime in 2017\. Recently, the agency posted a [question and answer document](http://www.fda.gov/downloads/MedicalDevices/InternationalPrograms/MDSAPPilot/UCM430563.pdf?ref=fdaweb.com) to provide more background on the pilot.