FDA Proposes Rule To Change Device cGMP Requirements
March 26th, 2022 // 1:50 pm @ jmpickett
Last month, FDA issued a proposed rule called Medical Devices; Quality System Regulation Amendments. It would feature an international standard that is specific for device quality management systems that are overseen by ISO.
Specifically, it would incorporate the 2016 version of ISO 13485, which is considered the international standard for device companies. FDA states it intends to amend the medical device cGMP requirements of the QS regulation so they better align with the international standard for medical devices by consolidating the QMS requirements that are used by device regulators in other countries.
With this new rule, FDA also proposes more requirements to align with requirements in the FD&C Act and its various regulations for implementation. FDA also is making edits to the CFR to make clearer the medical device cGMP requirements for combination products.
If this act is finalized, it will continue the agency’s efforts to align its device regulatory framework with what is used by regulatory bodies in other countries.
