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The U.S. Food and Drug Administration (FDA) released an updated Mammography Quality Standards Act and Program (MQSA) Scorecard, which offers answers to the most commonly requested national statistics regarding the MQSA program. These statistics are updated on the first of each month.
May 18, 2012 — The U.S. Food and Drug Administration (FDA) has published a draft guidance document entitled "Pediatric Information for X-ray Imaging Device Premarket Notifications." The document encourages manufacturers to consider the safety of children in the design of new X-ray imaging devices.
October 17, 2011 — The U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have established a pilot program for concurrent review of medical devices. Under the process, certain FDA premarket review submissions and CMS national coverage determinations will be simultaneously reviewed.
October 7, 2011 — U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, M.D., released a blueprint containing immediate steps to drive biomedical innovation, while improving the health of Americans.
August 25, 2011 — Bayer HealthCare Pharmaceuticals Inc. announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its investigational compound, radium-223 chloride, exclusively licensed from Algeta ASA. The compound is for the treatment of castration-resistant (hormone-refractory) prostate cancer in patients with bone metastases.
July 29, 2011 — The U.S. Food and Drug Administration (FDA) this week issued draft guidance that clarifies when changes or modifications to a previously cleared 510(k) device require a new premarket submission.
July 21, 2010 – The Advancing Patient Safety Coalition sent a letter to the U.S. Food and Drug Administration earlier this month, urging the agency to immediately issue rules on unique device identification (UDI), which have been three years in the making.
April 27, 2010 – The U.S. Food and Drug Administration (FDA) today announced it is changing the way it operates its medical device advisory panels, effective May 1.
March 12, 2009 – Today, FDAnews and the Neocure Group revealed details today of the upcoming Medical Device Reimbursement Strategies Workshops, which will be held in Boston (April 30-May 1) and Minneapolis (August 24-25).
July 16, 2008 - Earlier this week, the FDA released a notification that the X-rays used during a CT examination may ...