How are surgical and clinical innovations in medical practice defined for the purpose of determining regulatory jurisdiction and oversight responsibility?: A scoping review

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.