Open Source Automated Insulin Delivery: Potential Pathways to Regulatory Approval

Laura Downey; Muireann Quigley; Shane O'Donnell; Tom Melvin

Open Source Automated Insulin Delivery: Potential Pathways to Regulatory Approval

Laura Downey
, Muireann Quigley
, Shane O'Donnell
, Tom Melvin

Birmingham Law School

Research output: Other contribution

61 Downloads (Pure)

Abstract

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
Type	Briefing note
Media of output	pdf document
Number of pages	6
Publication status	Published - Nov 2023

Bibliographical note

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

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Access to Document

Downey et al - OS AID Pathways to Regulatory Approval - Nov 2023Final published version, 559 KBLicence: Creative Commons: Attribution (CC BY)

https://blog.bham.ac.uk/everydaycyborgs/wp-content/uploads/sites/95/2023/12/OS-AID-Pathways-Approval-V4.pdfLicence: None: All rights reserved

A European regulatory pathway for Tidepool loop following clearance in the United States?
Downey, L., O'Donnell, S., Melvin, T. & Quigley, M., 24 Oct 2023, (E-pub ahead of print) In: Diabetic Medicine. 8 p., e15246.
Research output: Contribution to journal › Article › peer-review

Open Access
File
210 Downloads (Pure)

Everyday Cyborgs 2.0: Law's Boundary-Work & Alternative Legal Futures
Quigley, M. (Principal Investigator)
The Wellcome Trust
1/09/19 → 31/12/26
Project: Research

Cite this

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title = "Open Source Automated Insulin Delivery: Potential Pathways to Regulatory Approval",

abstract = "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{\textquoteright}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",

author = "Laura Downey and Muireann Quigley and Shane O'Donnell and Tom Melvin",

note = "Based on research presented in Laura Downey, Shane O{\textquoteright}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",

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AU - Downey, Laura

AU - Quigley, Muireann

AU - O'Donnell, Shane

AU - Melvin, Tom

N1 - 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

PY - 2023/11

Y1 - 2023/11

N2 - 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

AB - 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

M3 - Other contribution

ER -

Open Source Automated Insulin Delivery: Potential Pathways to Regulatory Approval

Abstract

Bibliographical note

UN SDGs

Access to Document

Fingerprint

Research output

A European regulatory pathway for Tidepool loop following clearance in the United States?

Projects

Everyday Cyborgs 2.0: Law's Boundary-Work & Alternative Legal Futures

Cite this