Posted 18 December 2015
By Michael Mezher
The US Food and Drug Administration (FDA) says it is discontinuing one of its audit-sharing pilots ahead of the launch of a "fully operational" Medical Device Single Audit Program (MDSAP) in 2017.
FDA announced the changes in the Federal Register on Thursday, saying it "will no longer accept ISO 13485:2003 Voluntary Audit Report Submissions after March 31, 2016, to assist transitioning manufacturers over to MDSAP."
ISO 13485:2003 Submission Pilot
In 2010, FDA released a draft guidance describing a pilot program to allow companies to use audits from other Global Harmonization Task Force (GHTF) founding members to meet the requirements of FDA's Medical Device Compliance Program. The guidance was finalized two years later, and the pilot program launched on 5 June 2012.
Under the pilot, establishments deemed to be low risk based on the submitted audit report are eligible to be removed from FDA's routine inspection work plan for one year, potentially limiting the number of audits an establishment will have to go through.
However, in October 2012, GHTF was dissolved, and work began under the International Medical Device Regulators Forum (IMDRF) to develop a new program, MDSAP, to facilitate audit sharing between regulators.
In January 2014, IMDRF launched a three-year pilot, which is scheduled to conclude at the end of 2016, to test the feasibility of MDSAP.
The goal of MDSAP is for audits from recognized auditing organizations to meet the requirements of all regulatory authorities participating in the program, including FDA, Australia's Therapeutic Goods Administration (TGA); Brazil's National Health Surveillance Agency (ANVISA); Health Canada; Japan's Ministry of Health, Labor and Welfare and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
Fully Operational MDSAP
In September, FDA released a mid-pilot report highlighting the progress made in the MDSAP pilot through July 2015. According to the report, many of the pilot's main objectives have already been met; however, the pilot has struggled to attract industry participation. Halfway through the pilot, only 45 manufacturing sites had requested to participate, a far cry from the 330 the pilot had hoped for.
However, speaking at RAPS' Regulatory Convergence in October, Kim Trautman, associate director, international affairs of the Office of the Center Director at CDRH, addressed concerns over industry participation in the program, suggesting that manufacturers were reluctant due to "fear of the unknown and change; or a lack of understanding the program."
Trautman also expressed confidence that the program would continue after the pilot phase ends in December 2016.