USA – New Report Compares FDA Quality System Requirements With ISO 13485:2016

The Association for the Advancement of Medical Instrumentation (AAMI) this week released a technical information report to help the medical device industry prepare for the revision of 21 CFR 820 (also known as the quality system regulation), which will harmonize with ISO 13485:2016 later this year.

The most recent regulatory agenda says that sometime this month the US Food and Drug Administration (FDA) will issue a proposed rulemaking on the harmonization and modernization of the quality system regulation for medical devices with the specifications of ISO 13485:2016. 

“The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements,” FDA said.

To help industry prepare for such changes, the AAMI report, which was developed and approved by a working group of industry and FDA experts, documents the relative and systemic differences and similarities between 21 CFR 820 and ISO 13485:2016, noting areas in risk management where ISO 13485:2016 is more prescriptive and explicit than the current quality system regulation, which was first written in 1996…