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The FDA announced that it will delay enforcement of new requirements for unique device identification (UDI) on class I and unclassified medical devices until Sept. 24, 2022. Read More
Former FDA Chief Scientist Jesse Goodman told a House subcommittee hearing that the FDA’s decision to allow diagnostic test developers to self-validate their COVID-19 products caused a flood of unqualified products on the market. Read More
The FDA sent warning letters to six device companies for violations including missing documents, design validations, and other compliance lapses. Read More
After a lengthy review, the U.S. Pharmacopeia (USP) has decided to continue recommending the use of decades-old reagents derived from horseshoe crab blood for detecting endotoxins in drugs rather than press for the use of new synthetic substitutes. Read More
Australia’s Therapeutic Goods Administration (TGA) said it is reviewing all approved serology-based COVID-19 point-of-care tests to verify their ability to detect SARS-COV-2 antibodies. Read More
