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The Food and Drug Administration
An Agency to Protect the Patient and the Physician
I. Sidney Jaffee, MD
Arch Facial Plast Surg. 2000;2:62-63.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text and any section headings. |
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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.
Devices are reviewed for safety and effectiveness. Patients, physicians, and even . . . [Full Text of this Article]
From the Ear, Nose, and Throat Division, US Food and Drug Administration, Rockville, Md.
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