FDA Reports on Status of Medical Device Single Audit Program

September 11, 2015—The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) announced the release of the Mid-Pilot Report for the Medical Device Single Audit Program (MDSAP) to provide the current status of the program’s performance goal and objectives. The complete report is available online here.

According to the CDRH, the goal of the MDSAP pilot is to provide objective evidence that a regulatory audit of a medical device manufacturer conducted by an MDSAP-recognized auditing organization can fulfill the needs of participating regulatory authorities. The MDSAP pilot’s objectives include developing the infrastructure, processes, training, and stakeholder commitment necessary to launch the operational phase of the MDSAP in January 2017.

In addition to the United States, the regulatory authorities of Australia, Brazil, Canada, and Japan are participating in the program. The World Health Organization’s Prequalification of In Vitro Diagnostics Program and the European Union are official observers.

In a related matter, the new version of ISO 13485 Quality Management System standard, an important element on which the MDSAP pilot is based, will publish in the coming months. Two years after the ISO 13485 standard is published, third-party auditing organizations or “registrars” may issue industry certifications only to the new version of the standard.

CDRH advised that the FDA encourages manufacturers to participate in the MDSAP pilot before the implementation of this key transition initiative, and before the program becomes mandatory in certain regulatory jurisdictions.

More information about the MDSAP and the participating regulatory authorities is available on the FDA’s MDSAP webpage, here.