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Current Diabetes Reports

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01-06-2017 | Economics and Policy in Diabetes (ES Huang and AA Baig, Section Editors)

The Role of the FDA and Regulatory Approval of New Devices for Diabetes Care

Authors: Shelley A. Jazowski, Aaron N. Winn

Published in: Current Diabetes Reports | Issue 6/2017

Abstract

Purpose of Review

The Food and Drug Administration (FDA) is responsible for assuring the safety, effectiveness, and quality of medical devices in the USA. Extensive review times coupled with the demand for necessary treatments have prompted the policymakers to implement measures to speed medical devices to market.The purpose of this review is to summarize the evolution of the regulatory pathways through which medical devices utilized in diabetes care gain market access.

Recent Findings

Regulatory pathways, ranging from premarket notification to premarket approval, require distinct, yet necessary (“least burdensome”) evidence demonstrating a device’s safety and effectiveness. Collaboration between manufacturers, regulators, and patients has resulted in the development and approval of novel diabetes care devices, including the first hybrid closed-loop artificial pancreas.

Summary

Policy provisions, ranging from the least burdensome approach to the “breakthrough device” expedited pathway, aim to balance innovation, access, and safety. Clinicians must be aware of the evolving regulatory landscape and play an active role in enhancing patient safety.

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Title: The Role of the FDA and Regulatory Approval of New Devices for Diabetes Care
Authors: Shelley A. Jazowski
Aaron N. Winn
Publication date: 01-06-2017
Publisher: Springer US
Published in: Current Diabetes Reports / Issue 6/2017
Print ISSN: 1534-4827
Electronic ISSN: 1539-0829
DOI: https://doi.org/10.1007/s11892-017-0871-6

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