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ISO 14971:2019 — Clarifying Benefit, Risk, & Benefit-Risk This is the third in a series of articles on the changes in the medical device risk management standard ISO 14971 that were released in December of 2019 and supported by guidance in the ISO TR 24971:2020 technical report or guidance on the medical device risk management standard. The standard and the technical report were reorganized and clarifications of the concepts of medical device risk management were included in the two documents. Few changes in the process resulted, but this article covers the change in the process for ben...

TGA Removes Some China Made Face Masks From the Therapeutic Goods Register The Therapeutic Goods Administration (TGA) has said that not all face masks meet the necessary regulatory requirements for safe use and may remove some masks from the Australian Register of Therapeutic Goods (ARTG) following a post-market review. The Australian sponsors of 5 out of 15 Chinese-made face mask products have been advised to issue either a product defect alert or product notification that describes the nature of the concern to their customers, “so that customers can consider the setting the face mask is ...