需要检验验证变更?如果未产生任何安全有效性方面未预期的问题,即可不用提交新的510(k),仅作为资料留存即可。关于材料变更:需比对材料类型,化学成分、灭菌过程。风险分析是否生物相容性方面风险增加? 该文件<Deciding When to Submit a 510(k) for a Change to an Existing Device>,提供了很多模板,可能可以用来作为...
DecidingWhentoSubmita510(k)foraChangetoanExistingDeviceThisdocumentisintendedtoprovideguidanceinthepreparationofaregulatorysubmission.ItdoesnotbindtheFDAortheregulatedindustryinanymanner.OfficeofDeviceEvaluationDocumentIssuedOn:January10,1997Note:Whilethisguidancedocumentrepresentsafinaldocument,commentsandsuggestionsmaybes...
The US Food and Drug Administration (FDA) has released two final guidance documents: Deciding When to Submit a 510(k) for a Change to an Existing Device, which applies to medical device changes broadly, and Deciding When to Submit a 510(h) for a Software Change to an Existing Device, wh...