FDA Reconfirms Continued Acceptance of Single Audits

For KAPSTONE MEDICAL

In an update to its review of the International Medical Device Regulators Forum report the FDA in December reconfirmed that it will continue to accept results of the Medical Device Single Audit Program (MDSAP) for medical device regulatory approval.

The MDSAP was a test of international safety and oversight that was started in 2012 in a meeting of interested regulatory agencies in Singapore. At that meeting the group of agencies developed specific documents for advancing a single regulatory audit of medical device manufacturers that satisfy relevant requirements of the regulatory authorities participating in the program.

Those agencies included:

• Therapeutic Good Administration – Australia
• Agencia Nacional de Vigilancia Sanitaria – Brazil
• Health Canada – Canada
• Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Device Agency – Japan
• The World Health Organization (WHO) Prequalification of in Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers – UN
• Food and Drug Administration - USA

Based on its evaluation of the MDSAP Final Pilot Report issued in July 2017, the MDSAP Regulatory Authority Council (the international MDSAP governing body) determined that the MDSAP Pilot had satisfactorily demonstrated the viability of the Medical Device Single Audit Program.

Consequently, with one exception, the FDA will continue to accept MDSAP audit reports as a substitute for routine Agency inspections. The exception affects firms subject to the Electronic Product Radiation Control (EPRC) provisions of the Act, which will continue to be subject to FDA inspections for EPRC activities.

The FDA acceptance of the international MDSAP is a welcome step toward reducing regulatory burdens for medical device makers, many of whom commented on the program, praising it for reducing the number of audits, reducing the number of resources needed for regulatory approval and shortening the audit cycle time for companies seeking market approval in key international markets.

It is expected that more countries will join the program in the coming years to further extend the value of the program.

The International Medical Device Regulators Forum (IMDRF) provides all the resources needed including a library of documents needed to make an easy transition to submission to the single audit program.

If you are a medical device maker interested in participating in the international single audit program, Kapstone Medical is well versed in international regulatory planning, as well as 510(k) submissions, CE Mark and quality systems development.