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The Gray Sheet  
   Full-text available via subscription Subscription journal
   ISSN (Print) 1530-1214
   Published by Informa plc Homepage  [13 journals]
  • People Briefs: Invacare, Chembio, Orthopediatrics and Hologic
    • Abstract: Invacare Corp. appoints president and CEO and more executive hiring from around the industry.
      PubDate: Fri, 23 Jan 2015 15:55:02 -050
  • Integra Resolves Warning Letter On Puerto Rico Facility
    • Abstract: The 2013 letter cited violations related to the company’s manufacturing facility in Añasco, which are now resolved. The company says it has made major investments in improving its quality systems.
      PubDate: Fri, 23 Jan 2015 12:00:00 -050
  • Proper Offsets Still The Barrier To A Permanent Doc Pay Fix
    • Abstract: Rep. Joseph Pitts, R-Pa., is adamant that legislators come up with approximately $140 billion in offsets to pay for a bill that would revamp Medicare physician reimbursement.
      PubDate: Thu, 22 Jan 2015 18:10:00 -050
  • Medtronic Launches Predictive MiniMed 640G Insulin
           Pump Outside The U.S.
    • Abstract: The company touts the system as its latest breakthrough toward the development of an artificial pancreas. It can automatically suspend or resume insulin delivery based on pre-set thresholds.
      PubDate: Thu, 22 Jan 2015 17:00:07 -050
  • Earnings Roundup: bioMérieux, Covidien, J&J
    • Abstract: Medtech financial results reports from the past week.
      PubDate: Thu, 22 Jan 2015 16:15:03 -050
  • Industry Wants More Details On Obama’s Precision Medicine Initiative
    • Abstract: The president announced a new plan before Congress that could bolster federal funding for diagnostics and personalized medicine. Industry commended the administration’s move but was also cautious due to the lack of detail and says it wants to be at the drawing table when specifics are put to paper.
      PubDate: Thu, 22 Jan 2015 12:05:02 -050
  • CDRH Touts Progress On Clinical Study Reviews
    • Abstract: The device center says that the number of review cycles and the median review time for investigational device exemptions dropped ahead of expectations during the past year. Aggressive goals remain for 2015.
      PubDate: Wed, 21 Jan 2015 18:15:02 -050
  • Obama Urges End To Corporate Inversions
    • Abstract: In his State of the Union speech, the President pledged to “close tax loopholes,” including his continuing efforts to ban U.S. firms from moving their tax headquarters overseas in corporate inversion deals. On the same day Democratic legislators introduced a bill to stop corporate inversions.
      PubDate: Wed, 21 Jan 2015 17:50:03 -050
  • 10 Things You Should Know About The Medical Device Single-Audit Pilot
    • Abstract: After a long build up, four international regulatory authorities officially rolled out the Medical Device Single Audit Program pilot this month. Here are 10 things companies should know about the program.
      PubDate: Wed, 21 Jan 2015 14:40:00 -050
  • Potential Benefits Of MDSAP Pilot Audits, By Jurisdiction
    • Abstract: What will an MDSAP audit get you? Here are the answers at different spots around the world, according to participating regulatory authorities.
      PubDate: Wed, 21 Jan 2015 14:40:00 -050
  • FDA Warning Letters: Jan. 6-20
    • Abstract: FDA posted three warning letters to device facilities in January so far, including a letter to gas-flow regulator developer Praxair for quality systems and adverse event reporting deficiencies.
      PubDate: Tue, 20 Jan 2015 18:15:01 -050
  • To Mitigate Endoscope Contamination Risk, Stop Backflows And Reprocess,
           FDA Says
    • Abstract: A draft guidance recommends prevention of backflow in flexible gastrointestinal endoscopes and reprocessing or discarding endoscopic devices with distal one-way valves to mitigate cross-contamination risks.
      PubDate: Tue, 20 Jan 2015 18:00:01 -050
  • CMS Allows Local Contractors Latitude For SCD Risk-Assessor
    • Abstract: After cardiologists strongly urged CMS to support MWTA testing using the modified moving average method to determine if patients are at risk of sudden cardiac death, CMS left an opening for local Medicare contractors to decide on coverage rather than retaining a national non-coverage policy.
      PubDate: Tue, 20 Jan 2015 17:30:00 -050
  • 'Acting' At CDRH: Two Top Offices Are Now Run By Interim Directors
    • Abstract: An update on CDRH's management structure.
      PubDate: Mon, 19 Jan 2015 10:00:19 -050
  • 2014 Hot Spots: Top 4 Device Quality & Regulatory Topics
    • Abstract: Big changes are afoot for inspections, and device stakeholders kept a sharp eye on those issues in 2014, according to readership data from "The Silver Sheet." From a CDRH/ORA plan to create a specialized unit of device-focused field investigators, to IMDRF's mostly untested internationally harmonized single-audit approach, readers (and podcast listeners) couldn't get enough news and tips about inspection activities. A recap of in-depth "Silver Sheet" coverage from the year, including updated expert commentary, follows.
      PubDate: Mon, 19 Jan 2015 10:00:01 -050
  • Marilyn Tavenner Stepping Down From CMS
    • Abstract: CMS principal deputy administrator Andy Slavitt steps in as acting administrator as Marilyn Tavenner plans to depart the agency after five years running the agency. She will leave at the end of February.
      PubDate: Fri, 16 Jan 2015 16:55:00 -050
  • mHealth Regs: FDA Drafts Wellness, Accessories Guidance Docs
    • Abstract: One proposal addresses regulatory policy for low-risk devices targeting "general wellness" and the other seeks to clarify how FDA intends to regulate products intended as accessories to devices. Mobile health developers have been on the lookout for both.
      PubDate: Fri, 16 Jan 2015 13:30:00 -050
  • Clinical Trial Transparency Gets A Boost With J&J Agreement, IOM
    • Abstract: Johnson & Johnson's device and diagnostic clinical trial data is now available to independent researchers via Yale University’s Open Data Access (YODA) Project, announced the same day as an Institute of Medicine report mapping out strategies for clinical trial data-sharing.
      PubDate: Thu, 15 Jan 2015 18:15:00 -050
  • HeartWare Studies Less-Invasive HVAD Implant Technique
    • Abstract: The 120-patient, single-arm LATERAL trial will evaluate a thoracotomy technique for implanting the HVAD ventricular assist device in bridge-to-transplant patients.
      PubDate: Thu, 15 Jan 2015 18:10:02 -050
  • Some Hospitals Are Overselling TAVR, Study Finds
    • Abstract: U.S. hospital websites promoting transcatheter aortic valve replacement tend are good at mentioning the benefits but often skip mentioning any risks of the procedure, according to a study published in JAMA Internal Medicine.
      PubDate: Thu, 15 Jan 2015 14:30:01 -050
  • Capitol Hill Briefs: Device Tax Repeal; Clinical Trials; DME Bidding
    • Abstract: Legislation introduced in the new Republican-controlled Senate include device tax repeal, a measure that would allow Medicaid recipients to enroll in clinical trials and a bill, introduced in parallel in the House, aimed at stopping non-binding bids for supplying durable medical equipment, prosthetics, orthotics and supplies.
      PubDate: Thu, 15 Jan 2015 14:25:00 -050
  • FDA Weighs Patient Risk Tolerance in Approving Obesity Device
    • Abstract: The agency approved EnteroMedics’ Maestro neuromodulator to treat obesity despite the device not meeting endpoints in its pivotal trial. The agency relied in part on a survey that found obese patients willing to take more risks in exchange for weight loss.
      PubDate: Wed, 14 Jan 2015 18:05:01 -050
  • FDA Lab-Developed Test Classification Panel ‘Dream Team’
    • Abstract: The Personalized Medicine Coalition’s executive VP Amy Miller spelled out a short list of appropriate FDA advisors who might sit on an advisory panel helping the agency make classification decisions for laboratory developed tests: An expert in personalized medicine Physician who evaluates personalized medicine LDTs Physician who orders and interprets LDT test results Diagnostics industry representative Sole-source laboratory supplier representative Academic laboratory representative Large reference lab representative FDA CDRH representative ...
      PubDate: Wed, 14 Jan 2015 17:15:00 -050
  • CDRH Compliance Director Steve Silverman Leaving FDA
    • Abstract: Silverman, who is moving on to pursue "opportunities outside of government," will be replaced on an interim basis by Jan Welch, deputy director for regulatory affairs in the compliance office.
      PubDate: Wed, 14 Jan 2015 15:10:00 -050
  • Lab Directors Look For Ways To Adjust To Proposed LDT Framework
    • Abstract: While many in the laboratory community protested loudly against FDA's plans to regulate lab-developed tests at a recent workshop, some tried to look ahead to how they could smoothly adjust to a dual regulatory system in which labs are regulated by CMS, while tests are approved by FDA.
      PubDate: Wed, 14 Jan 2015 14:20:02 -050
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