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The Role of the FDA and Regulatory Approval of New Devices for Diabetes Care. Curr Diab Rep 2017 06;17(6):40



Pubmed ID





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. 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.

Author List

Jazowski SA, Winn AN


Aaron Winn PhD Assistant Professor in the School of Pharmacy Administration department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Device Approval
Diabetes Mellitus
Equipment Safety
Pancreas, Artificial
Patient Safety
United States
United States Food and Drug Administration
jenkins-FCD Prod-482 91ad8a360b6da540234915ea01ff80e38bfdb40a