Results 181 to 190 of about 315,340 (245)

FDA-Regulated AI-Enabled Medical Devices With Pediatric Indications.

open access: yesJAMA Netw Open
Zapotoczny G   +5 more
europepmc   +1 more source

Performance Standards for Medical Device Approvals

Archives of Otolaryngology - Head and Neck Surgery, 1995
As a result of the controversy concerning the safety of silicone and other permanent implants, the Food and Drug Administration's Center for Drug Evaluation and Research has conducted a rereview of a small sample of applications by manufacturers. The Food and Drug Administration's "Final Report of the Committee for Clinical Review" found that clinical ...
F H, Silver, A I, Glasgold
openaire   +2 more sources

FDA-Approved Densitometry Devices

2003
The devices discussed in this chapter are available in the United States for clinical use. The specifications were provided by the manufacturers and are subject to change without notice as devices are continually upgraded to reflect advances in the technology. The categories of information provided by each manufacturer may vary slightly. All categories
openaire   +1 more source

Drug and Device Approval Highlights from 2001

The Nurse Practitioner, 2002
The U.S. Food and Drug Administration approved more than 100 drugs and devices in 2001. This article discusses several of the new approvals, including ophthalmic drugs, contraceptive therapies, mental health medications, and medical devices.
Deborah, Kupecz, Candace, Berardinelli
openaire   +2 more sources

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