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 Description | Milestone Date | Milestone Status | Milestone 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 |
Foot Notes
- At this time, this project will remain active as CDRH is considering adding additional milestones.
Key Projects Legend
Milestone Status | Definition |
---|---|
Not Yet Started | Work for specific milestone has not yet been started. |
Completed | Milestone and/or overall project is completed. |
On Track | Milestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status. |
On Hold | Milestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status. |
Delayed | Milestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status. |