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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140033, DEN150035, DEN150055 and DEN160019 added)
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1st Quarter FY 2017 MDUFA III Performance Report
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Oncologic Drugs Advisory Committee Roster
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150007 and DEN160032 added)
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Presentations posted for February 23, 2017 Circulatory System Devices Panel of the Medical Devices Advisory Committee
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Presentation and Transcript added to Webinar – Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions Final Guidance
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Neurovascular Thrombus Retrieval Catheters and Guide Catheters Used During Neurological Interventional Procedures: Differences in FDA Review and Intended Use
March 1, 2017 To promote safe and effective use of medical devices, the FDA’s Center for Devices and Radiological Health (CDRH) is clarifying the differences between neurovascular thrombus retrieval catheters and neurovascular guide catheters (e.g., intermediate catheter, distal access catheter). These devices are both cleared by FDA through the 510(k) premarket notification program. However, FDA…
Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall
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Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free”: Recall
[Posted 02/24/2017] AUDIENCE: Pharmacy, Risk Manager ISSUE: Advanced Pharma, Inc. d/b/a Avella of Houston, is conducting a voluntary recall of all unexpired sterile injectable products labeled “latex free” that were produced at Advanced Pharma, Inc.’s Houston location between September 1, 2016 and February 16, 2017 to the user level (hospitals and institutions) because such products…