Orthopedic device data guidance issued
This article was originally published in The Gray Sheet
Executive Summary
Firms should clearly identify numbers of patients and not just percentages when presenting data from clinical studies, according to 1orthopedic guidance issued by CDRH. The December guidance stresses that complication and adverse events should be accurately recorded, noting that for PMAs a minimum of 85% of patients followed is recommended to sufficiently power a study. CDRH provides sample tables for recording demographics, patient accounting, adverse events, surgical revisions and effectiveness...