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)

Europe

• 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)

India

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

China

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

Japan

• 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)