Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery
-
Otolaryngol Head Neck Surg · Sep 2015
Postmarket Modifications of High-Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration.
The US Food and Drug Administration (FDA) grants initial marketing clearance for novel high-risk medical devices via the premarket approval (PMA) pathway, which requires clinical data demonstrating safety and effectiveness. Manufacturers may subsequently file supplemental PMA applications (supplements) to implement incremental device changes, usually without additional clinical data. Given the potentially significant clinical implications of using new device models, this study characterized the frequency and nature of changes to high-risk therapeutic otolaryngic devices cleared via the PMA pathway. ⋯ A substantial number of incremental changes have been made to high-risk therapeutic otolaryngic devices over time, including many major design changes without supporting clinical data.
-
Otolaryngol Head Neck Surg · Sep 2015
The Changing Landscape of Vestibular Schwannoma Management in the United States--A Shift Toward Conservatism.
To characterize the evolving management of vestibular schwannoma (VS) in the United States. ⋯ While the incidence of VS has remained steady, tumor size at time of diagnosis has decreased over time. Within the United States there has been a clear, recent evolution in management toward observation.