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Latest Center for Devices and Radiological Health Stories

2014-07-22 08:24:01

NORTHBROOK, Ill., July 22, 2014 /PRNewswire/ -- UL (Underwriters Laboratories), a global safety science leader, has announced that the U.S. Food and Drug Administration (FDA) has recognized two UL battery safety standards as consensus standards for medical devices incorporating lithium or nickel-based batteries. The two standards are UL 2054 - Standard for Household and Commercial Batteries, and UL 1642 - Standard for Lithium Batteries (Cells)....

2014-07-16 12:27:49

BETHESDA, Md., July 16, 2014 /PRNewswire-USNewswire/ -- The Parenteral Drug Association (PDA) has confirmed FDA's Stephen Ostroff, M.D., Acting Chief Scientist in the Office of the Commissioner will present "FDA's Views on Scientific Advances and their Impact on Manufacturing of the Future" on September 8, 2014 in at the opening plenary session of the 2014 PDA/FDA Joint Regulatory Conference in Washington, DC at the Renaissance Hotel. The Conference dates are September 8-10, 2014,...

2014-06-18 23:08:45

Bellwether Trials Expected to Begin in Either Mid-2015 or Early 2016 DALLAS (PRWEB) June 18, 2014 The national law firm of Baron and Budd reports that the U.S. District Court, District of Massachusetts held a Status Conference on May 9, 2014 in regard to federal multidistrict litigation (MDL) for GranuFlo lawsuits. The Court filed a Joint Status Report stating that, included in the matters discussed during the conference were potential dates for the MDL’s bellwether trials. According to...

2014-06-14 23:01:07

The hot topics for Tuesday, June 17 SAN DIEGO (PRWEB) June 14, 2014 Examine the changing landscape for bioinnovation, the impact of “big data” on vital research partnerships, an initiative that pioneers patients’ access to data, and the growth of human tissue models on microchips on Tuesday, June 17, at the DIA 2014 50th Annual Meeting at the San Diego Convention Center. In addition, the world’s foremost regulators will come together that day to discuss fostering globalization in...

2014-06-11 16:27:10

FALLS CHURCH, Va., June 11, 2014 /PRNewswire-iReach/ -- 11(th) Annual Medical Device Quality Congress: Managing the "Big Five" Quality Concerns **Presented by FDAnews** June 24-26, 2014 - Bethesda, MD http://www.fdanews.com/MDQC2NewFDASpeakers Photo - http://photos.prnewswire.com/prnh/20140610/116829 Two new FDA Speakers are confirmed for the Eleventh Annual Medical Device Quality Congress: -- William MacFarland, Director, Division of Manufacturing and Quality, OC, CDRH, FDA...

2014-05-28 12:33:14

FALLS CHURCH, Va., May 28, 2014 /PRNewswire-iReach/ -- 11(th) Annual Medical Device Quality Congress: Managing the "Big Five" Quality Concerns **Presented by FDAnews** June 24-26, 2014 - Bethesda, MD www.fdanews.com/MDQCKeynoteSpeaker Photo - http://photos.prnewswire.com/prnh/20140528/91797 FDAnews is pleased to announce that Steven Silverman, Director, Office of Compliance, CDRH, FDA has been selected to present the keynote address at the 11(th) Annual Medical Device Quality Congress. As...

2014-05-23 23:09:50

Ashley Brittain Landers of Schlichter, Bogard & Denton, LLP reports that the FDA has issued proposed orders to reclassify transvaginal mesh devices to the classification of high-risk. The attorneys at Schlichter, Bogard & Denton, LLP are offering free and confidential case reviews to those who allege to have suffered serious injuries associated with the use of transvaginal mesh (TVM) devices. St. Louis, MO (PRWEB) May 23, 2014 On April 29, 2014, the FDA issued an immediate release...

2014-05-13 23:02:01

Sessions to provide key regulatory updates from international leaders Washington (PRWEB) May 13, 2014 Leading drug and medical device regulators from around the world will offer insight on their home countries’ and continents’ regulatory landscape during town hall sessions at the DIA 2014 50th Annual Meeting, from June 15 to 19 at the San Diego Convention Center. Regulatory innovators from the U.S., Europe, Canada and Asia will lead the discussions. Guido Rasi, executive director of...

2014-04-24 16:29:57

FALLS CHURCH Va., April 24, 2014 /PRNewswire-iReach/ -- Software and Cybersecurity Risk Management for Medical Devices: Learn Best Practices from FDA and Industry Experts **Presented by FDAnews and GessNet** May 21-22, 2014 - Bethesda, MD www.fdanews.com/SoftwareCybersecurity (Photo: http://photos.prnewswire.com/prnh/20140424/78173) This workshop, chaired by internationally renowned expert Fubin Wu and featuring three FDA experts, has been specifically designed to provide devicemakers with...

2014-04-08 16:23:37

Southeastern Medical Device Association (SEMDA) Addressing Reform Impact Head-on ATLANTA, April 8, 2014 /PRNewswire/ -- The 8(th) Annual SEMDA Conference, entitled "Thriving During Healthcare Reform," will feature an industry update by Jeffrey Shuren MD, JD, Director of the FDA's Center for Devices and Radiological Health (CDRH). During his presentation, Dr. Shuren will discuss recent agency programs and their impact on the medical device industry. In addition, Stephen J. Ubl,...


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bibliopole
  • A bookseller; now, especially, a dealer in rare and curious books.
This word comes from a Greek phrase meaning 'book seller.'
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