Medical Innovation Exchange

RC – Medical Device Audits, Certification & Verification

FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions

FDA Issues Final Guidance on “Device” and “Counterfeit Device” Definitions     The FDA has issued the final guidance: Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents.  The guidance is intended to clarify the FDA’s approach for referencing the terms “device” and “counterfeit device” …

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Preparing for a Data-first Regulatory World

Preparing for a Data-first Regulatory World     Even in today’s eCTD world, most life sciences regulatory teams still think and work in terms of documents, paragraphs and sentences when putting together collateral for marketing authorization and variations submissions. Yet it is data, rather than pre-prepared dossiers, that are moving into central focus now. Stakeholders across …

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