Planning for effective interaction with FDA.
Manufacturers of diabetes devices can facilitate the formal regulatory approval process through early interaction with the U.S. Food and Drug Administration (FDA). Effective planning can help manage commonly perceived risks of interaction with the Agency, introduce new technologies to regulatory reviewers, and inform the manufacturer's product development strategy. This article reviews key aspects of the FDA evaluation process and suggests strategies that may facilitate effective communication with the Agency. Integrating early communication with FDA into broader product commercialization planning can streamline regulatory review and lead to early product launch into reimbursed markets.
Spurgin
Elizabeth A
EA
Aventor, Washington, DC 20005, USA. espurgin@aventor.com
D000368:Aged; D002986:Clinical Trials as Topic / Q000592:standards; D006801:Humans; D007373:Interinstitutional Relations; D007398:Interpersonal Relations; D040541:Marketing; D006278:Medicare; D014481:United States; D014486:United States Food and Drug Administration