On Feb. 22, 2022, the FDA released its long-awaited proposed rule that would align the agency’s quality system (QS) regulation more closely with ISO 13485, the internationally recognized consensus standard for device quality management systems (QMSs).

The proposed rule, nearly four years in the making and repeatedly delayed because of the FDA’s need to respond to COVID-19 public health emergency and other factors, would force device manufacturers to undertake a painstaking reassessment of their quality systems — particularly their applications of risk management principles to quality concerns throughout the product life cycles of their products.

At the same, the proposal would substantially streamline quality standards compliance requirements for device firms that currently must meet separate sets of quality mandates imposed by the FDA and by non-U.S. regulatory authorities.

This Thompson FDA white paper discusses the lead-up to the release of the proposed rule, the details of the proposal, FDA commentary on the proposed rule, and initial device industry reaction to the proposal. The white paper can help device companies position themselves for the critical work ahead as they begin to transition their quality systems to align with the emerging revised mandates.