Facebook
  1. Home
  2. Insights
  3. Blog
  4. Fewer Third-Party Device ISO Report Auditors Authorised Under MDSAP in U.S. and Canada

Fewer Third-Party Device ISO Report Auditors Authorised Under MDSAP in U.S. and Canada

Melvin G. Fletcher

III ISO 13485, CMDR, and MDD/CE Marking Certified Lead Auditor ICON Regulatory Services

New rules from the U.S. Food and Drug Administration (FDA) and Health Canada have restricted the number of third-party organisations authorised to audit ISO reports.

Effective March 31, 2016, the U.S. Food and Drug Administration (FDA) terminated the Medical Device ISO Voluntary Audit Report Pilot Program. This program had allowed submission of ISO audit reports performed by third parties, along with audit reports from the preceding two years, to determine if the owner or operator of the medical device establishment could be removed from FDA's routine inspection work plan for one year.

That day the FDA also opened the operational phase of the Medical Device Single Audit Program (MDSAP), which allows third parties recognised by the MDSAP consortium to submit audit reports that the FDA will utilise for routine inspections.

At the start of 2017, MDSAP will be fully operational and open applications for additional auditing organisations beyond the limited eligible auditing organisations within the current pilot phase. Each regulator within the consortium has committed to continuing to utilise the MDSAP audits during the pilot as well as during the operational phase, as described in the MDSAP public announcements.

Health Canada has also specified a timeframe for replacing its Canadian Medical Device Conformity Assessment System (CMDCAS) program with MDSAP as the means by which manufacturers will obtain a medical device license for distribution of medical devices in Canada.

For some companies, the FDA’s March 31 termination date for ISO 13485:2003 Voluntary Audit Report Submissions and Health Canada’s progressive transition timeline may disrupt plans to use third-party prepared ISO audit reports. These reports held significant value, as they had the potential to remove the sponsor from the agency’s routine inspection work plan for one year.

However, the full participation of the FDA in the MDSAP program is a positive development because the FDA will begin to accept MDSAP audits in place of FDA routine inspections. (The FDA does retain the right to perform an inspection at any time.) The FDA’s participation in MDSAP gives companies more control over when a third party audit is scheduled.

Additionally, that single audit will not only be compliant with FDA regulations, but also other standards and regulations such as ISO 13485:2003, Canadian Medical Device Regulations, Australian Therapeutics Goods Administration (TGA), and the Brazilian National Health Surveillance Agency ANVISA.

If you need any assistance with navigating the new requirements and the preparations for an MDSAP audit, please contact ICON for more information.

In this section

Connect with us