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.

The document also maps 21 CFR 820 to ISO 13485:2016 and vice versa, as AAMI explains that companies should review the alterations in both directions.

“An example of this is 21 CFR 820 supplier controls compared to ISO 13485:2016 outsourced suppliers and purchasing controls and the need for quality agreements,” the report says. “While there are no incongruities among the requirements for the quality management systems, there may be some verbiage or directed differences. This difference may not have been noticed reviewing the requirements in only one direction.”

In addition, the report offers line-by-line charts laying out the similarities and differences and also discusses key considerations on definitions, training and competence, approvals versus signatures, risk management, and corrective and preventive actions versus improvement processes.