Postmarket Safety

Canadian Government Proposes New Measures, Fines for Unsafe Drugs

Health product safety legislation introduced by Canada’s conservative government would require devicemakers to revise product labels to reflect new risk information, including updates on pediatric warnings, and conduct further tests when issues arise around at-risk populations. Read More

Industry Seeks Extensions, Clarity In Final Version of UDI Guidance

The FDA’s final guidance on unique device identification should allow for submission of UDI data elements within 10 days of commercializing a device, rather than requiring that they be in the Global UDI Database before market launch, as the stricter requirement could lead to lost sales, AdvaMed says. Read More