A note providing a broad overview of the regulatory pathways and processes that may be encountered by those seeking regulatory approvals for Open Source Automated Insulin Delivery apps/software in the United States, the European Union (including Northern Ireland), and Great Britain. It focuses on the distinctions in institutional structure, device classification, and processes for regulatory approval or conformity assessment in the three jurisdictions.
The note is based on research presented in Laura Downey, Shane O’Donnell, Tom Melvin, and Muireann Quigley, “A European regulatory pathway for Tidepool loop following clearance in the United States?” Diabetic Medicine 2023;00:e15246. https://doi.org/10.1111/dme.15246
Original language | English |
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Type | Briefing note |
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Media of output | pdf document |
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Number of pages | 6 |
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Publication status | Published - Nov 2023 |
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Based on research presented in Laura Downey, Shane O’Donnell, Tom Melvin, and Muireann Quigley, “A European regulatory pathway for Tidepool loop following clearance in the United States?” Diabetic Medicine 2023;00:e15246. https://doi.org/10.1111/dme.15246