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PubMed · 14682021

FDA pilot programme in support of global harmonisation.

Maria E Donawa
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Abstract

Imagine having one document that would demostrate the conformity of a medical device with regualtory requirements worldwide. Although it may be some time before this goal is reached, the United States Food and Drug Administration is launching a premarket review pilot programme in support of global harmonisation. This article discusses the programme and why European manufacturers should consider participating.

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Device ApprovalEquipment Failure AnalysisEquipment and SuppliesGovernment ProgramsGuideline AdherenceGuidelines as TopicInternational CooperationPilot ProjectsProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug AdministrationJournal Article

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Maria E Donawa. 2003. FDA pilot programme in support of global harmonisation.. https://pubmed.ncbi.nlm.nih.gov/14682021/

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