USA: Quality System Regulation Amendments for medical devices and harmonization with international standards

 

The American Food and Drug Administration (FDA) has proposed to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for medical devices.

This may happen by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries). FDA proposes to do so through incorporating by reference an international standard specific for device quality management systems set by the International Organization for Standardization (ISO), the 2016 edition of ISO 13485 (ISO 13485).

Through this rulemaking, 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 make conforming edits to the Code of Federal Regulations (CFR) to clarify the device CGMP requirements for combination products. This action, if finalized, will continue our efforts to align the US regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients.

Currently, the US device CGMP requirements as set forth in the QS regulation, codified in part 820 (21 Code of Federal Regulation part 820).  FDA is proposing to amend the current part 820, primarily, through incorporating by reference the quality management system requirements of ISO 13485. As FDA has determined, the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the current part 820, providing a similar level of assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective and otherwise in compliance with the FD&C Act.

The full text of the proposed Rule can be found HERE.

# product compliance for medical devices