MDSAP Extends Pilot Program Allowing Medical Device Organizations to Apply for Certification
The Medical Device Single Audit Program has issued MDSAP Transmittal Number AO 2026-02, dated 20 July 2026, announcing an extension of the pilot program allowing eligible Medical Device Organizations to participate in and apply for MDSAP certification.
The transmittal has an effective date of 1 August 2026.
Pilot Program Extended Until April 2027
The document states that the pilot program, initially launched on 1 August 2025, has been extended until April 2027.
The MDSAP Regulatory Authority Council will evaluate the results of the pilot during its March 2027 meeting.
Based on that evaluation, the Council will determine whether to terminate the pilot and proceed with the general adoption of the revised eligibility criteria for Medical Device Organizations, or take other appropriate actions.
Revised Participation Limits
The transmittal also revises the participation limits for the pilot program.
Each Auditing Organization is now limited to a maximum of 40 MDO facilities or no more than 8% of its total MDSAP facilities, whichever is smaller.
According to the document, this increases the current participation level.
Quarterly Reporting by Auditing Organizations
The document requires all Auditing Organizations to submit a list of Medical Device Organizations participating in the pilot program on a quarterly basis.
These lists must be submitted to the relevant Assessment Program Manager to support monitoring of participation and compliance with the program limits.
Additional Procedure Reference
The transmittal refers to the updated procedure MDSAP AU P0038.002 – Eligibility of Medical Device Organizations to apply for MDSAP certification for additional details.
The transmittal was approved by Kimberly Lewandowski-Walker, RAC Chair, and issued by the MDSAP Regulatory Authorities.
Impact on Medical Device Manufacturers
For medical device manufacturers and organizations considering MDSAP certification, the extension of the pilot program provides additional time and capacity to assess eligibility and participation.
Organizations should pay particular attention to:
revised eligibility criteria for MDO participation;
updated participation limits applied to Auditing Organizations;
availability of pilot participation slots;
timing of the March 2027 RAC evaluation;
quarterly monitoring and reporting by Auditing Organizations;
requirements described in procedure MDSAP AU P0038.002;
potential transition from pilot status to general adoption.
For eligible Medical Device Organizations, the extension may create further opportunities to participate in the MDSAP certification pathway before a final decision is made on broader adoption.
