New Medical Device Quality Rules Are on the Way from the FDA

In case you haven’t heard, the FDA recently updated its Quality System Regulation/Medical Device Good Manufacturing Process. The changes are slated to take effect Feb. 2, 2026.

The FDA reports that on Jan. 31, 2024, it issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to better align with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.

The rule also establishes requirements that clarify certain expectations and concepts used in ISO 13485. The change is part of the FDA’s efforts to align its regulatory framework with that of other regulatory authorities. It also promotes consistency in the regulation of devices and provides a timelier introduction of safe and effective devices for patients.

Read more about the guidelines in this Q&A from the FDA.

ASG specializes in manufacturing engineering for regulated industries. One of ASG’s core manufacturing goals is to operate in Good Engineering Practice.

Learn more about ASG’s approach to manufacturing.