How are surgical and clinical innovations in medical practice defined for the purpose of determining regulatory jurisdiction and oversight responsibility?: A scoping review - 14/01/25
Abstract |
Background |
Various jurisdictions such as the US, Canada, and the UK have regulatory frameworks overseeing pharmaceuticals, medical devices, and medical research, with categorization determining authority and responsibility for oversight. Unclear categorization poses health policy concerns, potentially hindering progress in fields like regenerative medicine.
Methodology |
This scoping review aims to clarify how surgical and clinical innovations, as well as medical practices, are defined for regulatory purposes. It maps current literature, clarifies key concepts, and provides a descriptive analysis.
Results |
The review elucidates key concepts related to the characterization and oversight of new medical interventions, highlighting inconsistencies, and identifying gaps needing clarity in regulation and characterization in medical practices.
Conclusion |
Addressing ambiguity in oversight is crucial. Clarifying definitions can enhance governance, advance medical interventions, promote innovation, and ensure patient safety in emerging biomedical fields.
Le texte complet de cet article est disponible en PDF.Keywords : Clinical innovation, Jurisdiction, Medical innovation, Oversight, Scoping review, Surgical innovation
Plan
Vol 33
Article 101044- 2025 Retour au numéro
Article précédent
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