Swissmedic has updated its Formal requirements guidance document to version 22.0, setting out administrative and submission requirements for applications, variations, medicinal product information, packaging, combination products, DMF/ASMF and special product types.

FDA has issued updated guidance on 510(k) submissions for hemodialysis blood tubing sets, covering device description, performance testing, biocompatibility, sterility, shelf life, packaging and labeling.