-
- Vinay K Rathi and Stacey T Gray.
- Department of Otolaryngology-Head and Neck Surgery, Massachusetts Eye and Ear Infirmary, 243 Charles Street, Boston, MA 02114, USA; Department of Otolaryngology, Harvard Medical School, Boston, MA, USA. Electronic address: vinay_rathi@meei.harvard.edu.
- Otolaryngol. Clin. North Am. 2019 Feb 1; 52 (1): 103-114.
AbstractMedical devices are essential in the diagnosis and treatment of otolaryngologic disease. The US Food and Drug Administration (FDA) is tasked with assuring the safety and effectiveness of these devices. Otolaryngologists, in turn, are often responsible for helping patients understand risks, benefits, and alternatives when deciding whether to rely on devices in their care. To best counsel patients, otolaryngologists should be aware of the strengths and limitations of device regulation by the FDA. This article reviews the FDA regulatory framework for medical devices, premarket evidentiary standards for marketing devices, and postmarket methods of safety surveillance.Copyright © 2018 Elsevier Inc. All rights reserved.
Notes
Knowledge, pearl, summary or comment to share?You can also include formatting, links, images and footnotes in your notes
- Simple formatting can be added to notes, such as
*italics*,_underline_or**bold**. - Superscript can be denoted by
<sup>text</sup>and subscript<sub>text</sub>. - Numbered or bulleted lists can be created using either numbered lines
1. 2. 3., hyphens-or asterisks*. - Links can be included with:
[my link to pubmed](http://pubmed.com) - Images can be included with:
 - For footnotes use
[^1](This is a footnote.)inline. - Or use an inline reference
[^1]to refer to a longer footnote elseweher in the document[^1]: This is a long footnote..