ISO 13485:2016, Section 4 – Quality Management System (general requirements, documentation requirements, quality manual, control of documents and records)Ĭontrol of Documents and Record Management - 21 CFR § 820 specifies the need to document the date and signature of the individual(s) approving documents and communicating changes to appropriate personnel in a timely manner. Below are some of the main requirements that will need to be reconciled with the new regulation. As we await the release of the new proposed rule, I’ve analyzed and prepared a summary of the potential changes’ impacts on medical device manufacturers once the proposed rule becomes final, making two assumptions: a) that a medical device manufacturer only complies with ISO 13485:2016 (absent additional international requirements), and b) that existing 21 CFR 820 requirements will remain the same. The latest version of ISO 13485 ( ISO 13485:2016) already contains several requirements that do not exist in 21 CFR 820. The tool, available for purchase here, will assist FDA in the proposed rulemaking to revise 21 CFR to harmonize with ISO 13485. It is a bi-directional tool that will help organizations identify the requirements of 21 CFR 820 that can be addressed through a QMS that complies with ISO 13485. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016, was released on Aug. 30, 2019 and it serves as the officially recognized mapping tool for the medical device industry. It is likely that, once the regulation is aligned with ISO 13485:2016, FDA will maintain its inspectional authority but the Quality System Inspection Technique (QSIT) will be revised.ĪAMI TIR102:2019, the U.S. For many years, medical device manufacturers have had to comply with both requirements, as well as other international requirements. The rule’s intent is to blend the FDA’s Quality System Regulation (QSR) with ISO 13485:2016 in an effort to harmonize requirements while modernizing the former, which hasn’t been updated since 1996.
Food and Drug Administration (FDA) announced a new proposed rule - Harmonizing and Modernizing Regulation of Medical Device Quality Systems - will be released this year.