From the Ear, Nose, and Throat Division, US Food and Drug Administration, Rockville, Md.
Prior to joining the Food and Drug Administration (FDA), I was in private otolaryngologic practice for more than 33 years. While in practice, I spent some years as a member of the Ear, Nose, and Throat (ENT) Medical Device Advisory Panel. The general perception of the FDA is that it is slow to approve new drugs and devices. Since joining the FDA, however, I have found this not to be true.
The Center of Devices and Radiological Health (CDRH) is one of several centers of the FDA. Within the CDRH is the Office of Device Evaluation (ODE), which is the office responsible for reviewing new device submissions. Certain devices may be approved provided they undergo postmarket surveillance for a specified number of years. Adverse events are reported to the CDRH using a standard reporting form.
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