News Feature | September 15, 2015

MDSAP Single Audit Program Meets Tepid Response

By Jof Enriquez,
Follow me on Twitter @jofenriq


The U.S. Food and Drug Administration (FDA) is having some difficulty attracting medical device companies to sign on with the Medical Device Single Audit Program (MDSAP), a global initiative to create a unified audit program for medical device manufacturing across multiple regulatory jurisdictions.

"Program participation by medical device manufacturers appears to be the primary challenge at the mid-pilot review," states the MDSAP Mid-Pilot Status Report published recently by the FDA.

According to the FDA report, 10 percent of auditing organizations (AOs), or at least 330 medical device manufacturing sites, should express interest in participating in the MDSAP by the end of 2016. However, as of July 23, 2015, only 45 manufacturing sites have expressed interest. Such a shortfall in the targeted number of participants at mid-pilot presents a challenge, since the FDA affirms that, "manufacturer participation is vital for the success of the program," which is slated for full implementation beginning Jan. 1, 2017.

Worth noting, however, is that program participation seems to have accelerated recently. A report chart shows that for the month of July 2015 alone, 20 manufacturing sites have signed on with the program. In comparison, a total of 25 sites were added during the preceding 11 months, since the start of the pilot in July 2014. 

"As more AOs become authorized to conduct MDSAP audits, a continuation of the positive slope is anticipated. It is too early to project whether target goals will be met," the FDA states in the report.

Under MDSAP, third-party audits by accredited AOs will be accepted by the FDA and regulatory bodies in MDSAP member countries in lieu of their own inspections of device manufacturing practices. Such a system aims to facilitate regulatory processes across borders while saving costs and minimizing disruption in manufacturing operations.

Per a report from Healthcare Packaging, the participating regulatory authorities under MDSAP are the Therapeutic Goods Administration of Australia, Brazil’s Agência Nacional de Vigilância Sanitária, Health Canada, Japan’s Ministry of Health, Labour and Welfare, the Japanese Pharmaceuticals and Medical Devices Agency, and the FDA. The World Health Organization (WHO) Prequalification of In Vitro Diagnostics Programme and the European Union are official observers.

Under MDSAP, only organizations recognized by the Canadian Medical Devices Conformity Assessment System (CMDCAS) are authorized to carry out regulatory audits.

According to Emergo, "of the 13 CMDCAS registrars identified as eligible to participate in the MDSAP pilot, six organizations have signed up as of July 2015, and have already undergone application reviews and assessments. MDSAP regulators expect that by the conclusion of the MDSAP pilot, all 13 organizations will have undergone these assessments." Two of the six organizations who have signed up already have completed all prerequisites for accreditation. FDA says it plans to accredit more AOs beyond CMDCAS registrars in the future.