New QMSR – US-FDA final rule (Part 820 / Part 4)

The US-FDA issued the Quality Management System Regulation (QMSR) Final Rule, which amends the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820), incorporating the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes.
This final rule is the latest action taken by the US-FDA to promote consistency in the regulation of devices. This action is intended to harmonize the US-FDA’s CGMP regulatory framework with that used by other regulatory authorities.
The rule is effective 2. February 2026, two years after publication. Until then, manufacturers are required to comply with the QS regulation (source: US-FDA – January 2024). 

In addition, the US-FDA wants to reinforce the need for computer system validation of manufacturing and QS systems in the medical device industry.

The 2002 Guidance for Industry (Draft), Computer Software Assurance for Production and Quality System Software (short: CSA) provides recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system.

When final, the CSA guidance will supplement FDA’s guidance, “General Principles of Software Validation” (“Software Validation guidance” – SaMD – Software as a Medical Device) except this guidance will supersede Section 6 (“Validation of Automated Process Equipment and Quality System Software”) of the Software Validation guidance (source: US-FDA – 2022).

CCS prepared a full assessment package and gap assessment incl. checklists for the new QMSR rule in combination with the CSA approach incl. e-Validation. Please contact us today for more information: