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Home » Devicemakers Critical of Guidance on 510(k) Product Sterilization
Devicemakers Critical of Guidance on 510(k) Product Sterilization
June 4, 2009
New requirements set out in a recent FDA draft guidance regarding special review and pre-clearance inspections for 510(k) devices sterilized by novel, nontraditional methods should not apply to products that predate the guidance and have a successful FDA inspectional history, according to Johnson & Johnson’s DePuy subsidiary.