Devices

Framework for Device Real-World Evidence Studies

The National Evaluation System for health Technology Coordinating Center (NESTcc) has published the NESTcc Data Quality Framework and NESTcc Methods Framework. The group says the frameworks were developed by subcommittees of experts from FDA, health systems, academia, and industry to provide guiding principles for medical device ecosystem stakeholders to ensure data quality and research methodologies in real-world evidence studies.

Developed from draft versions circulated for public comment last year, the frameworks will evolve in future iterations to incorporate additional data sources for data quality assessment, real-world evidence samples, and further methodology best practices, NESTcc says.

The data quality framework focuses primarily on the use of electronic health record data in the clinical care setting and considers topics including data governance, characteristics, capture, and transformation, as well as the curation of data. The methods framework is applicable to many different data sources and defines the key components of a study protocol for the evaluation of medical devices.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome