Method comparison studies: Assessing Agreement for Medical Devices
View Presentation *Shanti V Gomatam, FDA/CDRH Keywords: Agreement, Bland Altman, Measurement error regression, diagnostic devices A method comparison study is often a supporting study for diagnostic medical devices cleared via the 510K regulatory pathway. In such studies the investigative devices is compared to either the clinical reference standard or a predicate device. We discuss, compare and contrast various statistical approaches that are used, or can be used, in method comparison studies.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC