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Location: Room 201ABCD
Title: US FDA Adoption of the Quality Management System Regulation - How Should You Prepare?
Event Type: Discover.Engineer.Build Conference
On February 23, 2022, the United States Food and Drug Administration proposed an amendment to 21 CFR 4 and 820. The purpose of the proposed change is to better align the agency’s medical device quality management system requirements with the international consensus standard for devices, ISO 13485: 2016 (the Standard), used by other regulatory authorities. This will affect quality management system (QMS) requirements for both medical devices and combination products involving both medical devices and drugs.
This follows on with similar harmonization activities promulgated by the agency to adopt international standards such as the adoption of the ISO 10993 series of biocompatibility requirements, thus ending the use of the tripartite biocompatibility guidance which had been established by the United States, the United Kingdom and Canada and ended in 1995. In both case, the switch from regional standards or agreements to broader international standards involved programs that were very similar on their own.
The differences in requirements between the regulations (21CFR 820 and 21CFR 4) and ISO 13485: 2016 are subtle. The overall intent is the same and that is that manufacturers establish controls that ensure that medical devices and combination devices (devices) are designed and manufactured resulting in products that are safe and effective. Therefore, the scope of the regulation remains unchanged. However, the details of the changes will become more impactful as manufacturers adopt the new requirements.
This will not be new to manufacturers that already conform to the requirements of the Standard. ISO 13485 has a much greater emphasis on risk management than the current regulations. Risk management occurs much earlier in the design process and the adoption of these principles for manufacturers that market medical devices in the United States will be expected. No doubt, this will be incorporated into the FDA’s QSIT (Quality System Inspectional Technique).
Further changes will be noticed in requirements for record-keeping. The FDA intends to place some of its own spin on the requirements of the Standard including signature and date requirements for records, complaint and servicing activities, UDI requirements and confidentiality. Additionally, there will be controls for device labeling and packaging, which retains requirements from the existing QSR and labeling inspection.
Again, these are not new requirements for existing manufacturers conforming to ISO 13485 because of the “baked in” requirements to meet “applicable regulatory requirements” that appear throughout the Standard.
