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.
Dr. Devaiah believes it is important for otolaryngologists to have a working knowledge of the process a device goes through as it moves from the idea phase through implementation and, in between, how it must move through the FDA approval process. To this end, as chair of the American Academy of Otolaryngology–Head and Neck Surgery (AAO-HNS) Medical Devices and Drugs Committee, he and his committee members have worked through different channels to help otolaryngologists understand and utilize this process.
FDA Approval Process: Medical Devices
Medical devices in the United States are regulated by the FDA’s Center for Devices and Radiological Health (CDRH). The first step in obtaining FDA approval for a medical device is to determine which of the three classes the device falls into, based on risk potential and complexity. Devices in all three classes must be registered on the FDA website, but only devices in classes 2 and 3 are required to undergo an approval process (see “Approval Process for Devices, by Class,” below).
There are two pathways for approval for class 2 and class 3 devices. For class 2 devices, a pathway known as the 510(k) is used if the proposed device can be shown to be substantially equivalent to one that has already received FDA approval. Typically, this pathway does not require clinical evidence of efficacy.