Testing a Cloud-Based Model for Active Surveillance of Medical Devices with Analyses of Coronary Stent Safety Using the Data Extraction and Longitudinal Trend Analysis (DELTA) System

Author:

Drozda Jr JosephORCID,Ssemaganda Henry,Frankenberger EdwardORCID,Brandt Eric,Robbins Susan,Khairnar Neha,Cha Alexandra,Resnic Frederic

Publisher

Informa UK Limited

Reference20 articles.

1. U.S. Food and Drug Administration. Medical device safety action plan: protecting patients, promoting public health. fda.gov. Available from: https://www.fda.gov/files/about%20fda/published/Medical-Device-Safety-Action-Plan--Protecting-Patients--Promoting-Public-Health-%28PDF%29.pdf. Accessed February 13, 2024.

2. National Evaluation System for health Technologies. Developing the NESTcc active surveillance portfolio. NESTcc; 2018. Available from: https://nestcc.org/developing-active-surveillance/. Accessed February 13, 2024.

3. Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration

4. The FDA Sentinel Initiative — An Evolving National Resource

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