FDA Terminating Voluntary Program Ahead of Operational Phase of MDSAP

The FDA is terminating its ISO 13485:2003 Voluntary Audit Report Pilot program effective March 31, in an effort to help manufacturers transition over to the Medical Device Single Audit Program.

The voluntary program has given devicemakers the chance to submit audit reports performed by third parties in order to be removed from the FDA’s routine inspection work plan for one year. The decision to discontinue the program comes as MDSAP is set to become fully operational in the beginning of 2017.

“The MDSAP program provides FDA better assurances than the ISO 13485:2003 Voluntary Audit Report Submission Pilot because FDA’s requirements under 21 CFR 820 or other FDA regulations typically covered during FDA inspections are encompassed within the MDSAP audit model,” the agency says in a Federal Register notice issued last month.

The FDA hasn’t seen the expected number of industry participants in the MDSAP pilot. As of July 23, 2015, only 45 sites had expressed an interest in participating in the program, far short of the target of 330 sites by the end of 2016. But, the agency seeks to pump up interest in the program (IDDM, Sept. 18, 2015).

Australia, Brazil, Canada, Japan and the U.S. are full members of the MDSAP Pilot. The European Union and the World Health Organization In Vitro Diagnostic Prequalification Program are official observers to the MDSAP Regulatory Authority Council.

Read the Federal Register notice here: www.fdanews.com/12-15-FDA-MDSAP.pdf. — Jonathon Shacat