This Week in Medical Device Regulation (10-14 November 2014)

Posted 16 November 2014 | By

This Week in Medical Device Regulation (10-14 November 2014)

Welcome to This Week in Medical Device Regulation, your weekly review of regulatory news and intelligence.

Regulatory Focus

  • FDA Authorizes Sixth Device to Help in Fight Against Ebola ( Regulatory Focus)
  • FDA Provides Some Clarity to Complex Regulatory Environment for Molecular Diagnostics ( Regulatory Focus)
  • Major Changes to Medical Device Registration Process in Japan ( Regulatory Focus)

US: Medical Devices

  • FDA's Gutierrez clarifies LDT review timelines ( BioCentury) ( FDA Law Blog)
  • First data flows from national registry tracking joint replacements ( Modern Healthcare)
  • Legislation on medical innovation may keep IT loosely regulated ( Modern Healthcare)
  • Suit Against FDA Challenged Legality of FDA’s Detention Without Physical Examination Process for Imports of Medical Devices and Reminds us that Sometimes Litigation is the Answer ( FDA Law Blog)
  • Power morcellation ban unlikely, but other FDA restrictions coming soon ( Fierce)
  • New LDT Guidance Documents Face Scrutiny ( GEN)
  • Toxic levels of a chemical in plastic medical devices could endanger preemies ( WaPo)
  • Becton Dickinson ordered to notify customers about false-advertising claims for safety syringes ( Fierce)
  • FDA's Gutierrez clarifies LDT review timelines ( BioCentury)
  • PMAs Proposed For Dynamic Spine Stabilization Devices ( Gray Sheet-$)
  • French Drug Firm Bets on Tiny Diabetes Device ( WSJ-$)
  • QSIT At 15: Two Co-Creators Of FDA’s Aging Audit Technique Look Back – And Mull Over Today’s Agency Approach ( Silver Sheet-$)
  • Records: Essure birth control maker, Conceptus, cited for malfunctioning, not reporting complaints ( NewsNet5)
  • Medical Device Cybersecurity: Five Questions the Industry Needs to Ask Now ( MDDI)
  • Medical Device Makers Challenged by FDA Mandates for UDI ( EMDT)
  • Companion Diagnostics: Why Medical Device Manufacturers Should Care ( MedDeviceOnline)
  • Qiagen set to benefit from increased test regulation by the FDA ( EP Vantage)
  • Former FDA Official Quynh T. Hoang Joins King & Spalding in Washington, D.C. ( Press)
  • Orthopedic Devices; Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems ( FDA)
  • Dassault Systèmes Signs Research Agreement with the Food and Drug Administration for its “Living Heart Project” ( Press)
  • MasterControl Continues Role as QMS Provider for FDA’s Office of Regulatory Affairs ( Press)
  • Device Recalled Over Software Issue ( FDA) ( FDA)
  • Recall for Siemens Diagnostic Device Over False Positives ( FDA) ( FDA)

US: Medical Devices: Study Results, Filings and Approvals

  • FDA Clears World’s First Patient-Specific Spinal Rod ( Press)
  • West Receives 510(k) Clearance for NovaGuard SA Safety System ( Press)
  • FDA Approves New Styles of Allergan’s NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants ( Press)
  • Roche Receives FDA Clearance for Strep A Test on cobas Liat System ( Press)
  • October 2014 510(k) Clearances ( FDA)
  • ImThera to begin U.S. testing of sleep apnea device ( Mass Device)
  • ReShape Duo Delivers Weight Loss In Sham-Controlled Pivotal Trial ( Gray Sheet-$)
  • SQI Diagnostics gets FDA clearance to market Celiac Panel in the US ( Press)
  • Zimmer Announces FDA Clearance of the Stand-alone Optio-C Anterior Cervical System for use with Structural Allograft/Autograft ( Press)
  • Titan Spine Receives FDA Approval for Next Generation nanoLOCK Surface Technology ( Press)

Ebola Outbreak

  • Industry and scientists developing new devices to treat Ebola ( Fierce)


  • Accelerated Device Reform In Europe? ( Silver Sheet-$)
  • NICE seeks more info on two med technologies ( PharmaTimes)
  • Augmenix wins CE Mark for TraceIT marking agents ( Mass Device)
  • ViewRay Receives CE Mark for MRIdian MRI-Guided Radiation Therapy System ( MedGadget)


  • Indian Device Industry Association Works to Build Trust in Devices ( PharmaBiz)


  • China Agrees to Drop Trade Tariffs Against US Medical Devices ( NYTimes) ( Gray Sheet-$)


  • Countdown to Japan’s new medtech law: what changes to look out for ( Clinica-$) ( Law 360-$)
  • Medtronic wins nod in Japan for Evera MRI-safe ICD ( Mass Device)

Other International

  • IVD Interoperability Standard Could Improve Laboratory Efficiency ( MDDI)
  • Device Changes Your Mood with a Zap to the Head ( MIT Tech Review)

General Regulatory And Interesting Articles

  • Diagnosing glaucoma by watching your iPad? It could be here sooner than you think. ( WaPo)
  • J&J's Super Weird Looking Light Therapy Mask ( MedCityNews)
  • How 3D printing could revolutionize burn treatment ( CBS)
  • Google Wants to Store Your Genome ( MIT Tech Review)


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