Date Issued: December 22, 2016 Audiences: Health care providers Pregnant women potentially exposed to Zika Medical Specialties: Primary care, Obstetrics and Gynecology, and Infectious Disease Product: The ZIKV Detect IgM Capture ELISA is manufactured by InBios International, Inc. The test is used for the preliminary (presumptive) detection of Zika virus IgM antibodies in human sera…
Updated Information on 3D Printing of Medical Devices
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Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical: Class I Recall
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Consumer Information on: Dexcom G5 Mobile Continuous Glucose Monitoring System
This is a brief overview of information related to FDA’s approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA’s approval. Product Name: Dexcom G5 Mobile Continuous Glucose Monitoring…
Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication
[Posted 12/16/2016] AUDIENCE: Internal Medicine, Pharmacy, Psychiatry ISSUE: Based on an FDA review of a large clinical trial that FDA required the drug companies to conduct, FDA determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected. The risk…
Class I Medical Device Recall: Greatbatch Medical Recalls Standard Offset Cup Impactor Used for Hip Joint Replacement due to Inadequate Sterilization
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Information on Medical Cribs Used in Homes and Child Care Settings
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Medical Gloves
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General Anesthetic and Sedation Drugs: Drug Safety Communication
[Posted 12/14/2016] AUDIENCE: Consumer, Surgery, Anesthesiology ISSUE: FDA is warning that repeated or lengthy use of general anesthetic and sedation drugs during surgeries or procedures in children younger than 3 years or in pregnant women during their third trimester may affect the development of children’s brains. Consistent with animal studies, recent human studies suggest that…
FDA Voice blog: Better Tool to Help Assess LASIK Patients
By: Malvina Eydelman, MD LASIK (laser-assisted in situ keratomileusis) eye surgery is an alternative for patients who need glasses or contacts to see well. Some 600,000 to 800,000 patients undergo LASIK in the U.S. each year, and a very high number of those patients are satisfied with their surgical outcomes. However, some patients develop unwanted…