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Infusion Pumps Total Product Life Cycle – Guidance for Industry and FDA Staff (PDF
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Class I Medical Device Recall: Philips / Children's Medical Ventures, Gel-E Donut and Squishon 2
Recall Class: Class I Date Recall Initiated: October 10, 2014 The recalled devices were manufactured and distributed from July 2012 to August 2014. See related Class I Recall. Use: The Gel-E Donut and Squishon 2 gel-filled devices are used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head and/or…
Emergency Use Authorizations (November 26 – Amended RealStar® Ebolavirus RT
2014 Ebola Virus Emergency Use Authorization 2013 Coronavirus Emergency Use Authorization (Potential Emergency) 2013 H7N9 Influenza Emergency Use Authorization (Potential Emergency) Historical Information, Termination of Declaration Letters and Additional Information 2013 Coronavirus Emergency Use Authorization (Potential Emergency) On May 29, 2013 Secretary Kathleen Sebelius determined that Middle East respiratory syndrome coronavirus (MERS-CoV) poses a significant…
Consumer Information on: IDEAL IMPLANT Saline-filled Breast Implant
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Summary Information for: IDEAL IMPLANT Saline-filled Breast Implant
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Recommended Labeling Statements for Laparoscopic Power Morcellators (PDF
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UPDATED Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication
The following information updates our April 17, 2014 communication. Date Issued: Nov. 24, 2014 Audience: Health Care Providers Medical Professional Associations Cancer Advocacy Organizations Health Care Facilities/Hospitals Women with Symptomatic Uterine Fibroids who are Considering Surgical Options Manufacturers of Devices used for Minimally Invasive Surgeries Medical Specialties: Pathology, Internal Medicine, Nursing, Obstetrics/Gynecology, Oncology, Obstetrics/Gynecological Surgery;…
Public Workshop Announcement – Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs), January 8
The purpose of this workshop is to discuss FDA’s proposal for a risk-based framework for addressing the regulatory oversight of a subset of in vitro diagnostic devices (IVDs) referred to as laboratory developed tests (LDTs), which are intended for clinical use and designed, manufactured and used within a single laboratory, and provide an additional opportunity…
FDA Voice Blog: China Journal: strengthening relationships to protect public health
By: Margaret A. Hamburg, M.D. I am just about to wrap up a jam-packed five-day visit to China, a fascinating country with a dramatically growing economy and with an increasingly significant impact on the products that Americans consume. Indeed, a key reason for my trip is the important and growing collaboration between FDA and our…