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U.S. Department of Health and Human Services

About FDA

Medical Device Single Audit Program (MDSAP)

Description: The overall objective of the Medical Device Single Audit Program is to develop, manage, and oversee a single audit program that will allow a single regulatory audit of a medical device manufacturer conducted by an MDSAP recognized auditing organization to satisfy the needs of multiple regulatory jurisdictions.

Briefing Status: Completed

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Establish draft audit model for the audit of medical device manufacturers by MDSAP recognized auditing organizations.

10/15/2012

Completed 10/16/2012

B. Solicit input from potential MDSAP auditing organizations on the draft audit model to be used during the audit of medical device manufacturers.

11/30/2012

Completed 11/30/2012

C. Establish draft MDSAP audit cycle including defining initial (certification), surveillance, and re-audits (re-certification).

12/30/2012

Completed 12/26/2012

D. Establish draft content for computer based training modules to be used to train potential MDSAP auditing organizations on how to conduct MDSAP audits of medcial device manufacturers.

2/28/2013

Completed 2/25/2013

E. Develop a draft MDSAP Project Acceleration Plan defining tasks necessary to launch an MDSAP pilot study in CY '14.

3/31/2013

Completed 3/22/2013

F. Solicit potential MDSAP auditing organizations for participation in the CY '14 MDSAP pilot study.

9/30/2013

Completed 3/28/2013

Footnotes

  • At this time, this project will remain active as CDRH is considering adding additional milestones.

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.