The U.S. Food and Drug Administration has announced that it will transition to ISO 13485:2016 after conducting a comparative analysis between the latter and the current Quality System Regulation (QSR).

In an official update from the FDA in December 2018, the reasons for and benefits of implementing ISO 13485 as the benchmark for quality management system audit inspections are outlined. In the presentation, the agency states: “The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation.”

The FDA also recognizes that there will be implications not only for FDA itself, which will have to retrain its inspectors and other staff as well as adapt its audit inspection requirements, but also for medical device production companies in the U.S. – especially those which have not been certified against ISO 13485:2016 before.

The transition to ISO 13485:2016 from the FDA will come alongside the coming into force of the MDSAP (Medical Device Single Audit Program) as conceived from the IMDRF (International Medical Device Regulators Forum) and EU MDR 2017/45 (the Regulation of the European Parliament and of the Council). The transition is about to happen soon, but impacted organizations will be able to adjust as long as they conduct the necessary management system changes, gap analyses, and internal audits.

PECB is here to help individuals to get trained and certified against ISO 13485:2016. This service is accredited by IAS (International Accreditation Service).