A Although U.S. Food and Drug Administration (FDA) is ubiquitous in the healthcare industry and medical community, knowing how the organization works to approve medical drugs and devices may be part mystery, part bewilderment, and for some, part aggravation given the bureaucracy typical of any large organization.
Explore this issue:May 2015
Tomes have been written on the FDA approval process, and easy-to-follow online resources are available to help those interested in navigating this process (See “Resources on the FDA Approval Process,”). This article is not meant to replace these resources, but will instead provide a brief primer on the FDA approval process with a focus on medical devices.
“Otolaryngology is a tech-heavy specialty … and we are driven to be very creative through technique and technology,” said Anand K. Devaiah, MD, associate professor in the departments of otolaryngology–head and neck surgery, neurological surgery, and ophthalmology at Boston University School of Medicine.