Food and Drug Administration Issues a Proposed Rule to Align its Quality System Regulation with the International Standard ISO 13485:2016

On February 23, 2022, the Food and Drug Administration (FDA) published a long-awaited proposed rule titled, Quality System Regulation Amendments (87 Fed. Reg. 10119).

The proposed rule covers medical devices and seeks to amend the current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation.  The agency hopes to align its rule more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries).

FDA’s reasoning for taking this action is to reduce the regulatory burden for device makers by eliminating redundancies in complying with both the US and international regulations.  FDA proposes to do so through incorporating by reference the 2016 edition of ISO 13485 (ISO 13485), an international standard specific for device quality management systems set by the International Organization for Standardization (ISO). FDA also proposes additional requirements to align with existing requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations, and to make conforming edits to the Code of Federal Regulations (CFR) to clarify the device CGMP requirements for combination products.

The comment deadline is May 24, 2022.

  • Submit written comments to the Federal Rulemaking Portal:
  • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
  • Advocacy contact: Linwood Rayford at 202-205-6533.