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Soft Tissue Fillers Labeling Request Letter to Industry
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Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication
Date Issued: May 28, 2015 Audiences: Health care providers who inject patients with facial soft tissue fillers Health care providers who treat patients following unintentional injection of soft tissue fillers into blood vessels People considering, or who have had, procedures that use soft tissue fillers Specialties: Dermatologists, plastic surgeons, cosmetic surgeons, dentists, and other medical…
Posted Presentation and Transcript for Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices Draft Guidance
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Posted Frequently Asked Questions about DBT and MQSA Training Requirements
Mammographic Modalities and MQSA Training Requirements Q. Is digital breast tomosynthesis (DBT) a mammographic modality under MQSA? A. Under MQSA, there are currently not one, but three different DBT modalities. MQSA defines a mammographic modality as “a technology for radiography of the breast.” As of April 2015, three DBT systems have been approved for marketing…
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN130019 added)
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Slides Added to Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices Draft Guidance
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24 Hour Summary and Webcast Links posted for May 14-15, 2015 Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee Meeting
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Consumer Information on: cobas KRAS Mutation Test
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Summary Information for: cobas KRAS Mutation Test
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