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New requirements for the clinical evaluation of medical devices in China, part of a regulatory overhaul that took effect June 1, could slow the introduction of innovative technologies there, industry experts say. Read More
The FDA’s draft guidance on distinguishing recalls from product enhancements contradicts current regulations, creating “a new sort of burden for industry,” an attorney says. Read More
The FDA has warned Smith & Nephew for failing to report a recall of the Renasys soft port dressing, which is used with its Renasys line of negative pressure wound treatment devices. Read More
Manufacturers are all but blocked from using split predicates for 510(k) devices, under a newly finalized FDA guidance on substantial equivalence determinations. Read More