This Week in Medical Device Regulation (17-21 November 2014)
Welcome to This Week in Medical Device Regulation, your weekly review of regulatory news and intelligence.
Regulatory Focus
- FDA Decides to Delay UDI Labeling Rule for Some Orthopedic Implants (Regulatory Focus)
- Pacemakers Get Hacked On TV, But Could It Happen In Real Life? (Regulatory Focus)
- Legislators Call on FDA to Study use of Plastic Microbeads in Toothpastes (Regulatory Focus)
- New Electronic Formatting Requirements in Canada for Class III and IV MDL Applications (Regulatory Focus)
- ANVISA to Allow Medical Device Firms to Evaluate Their Inspections (Regulatory Focus)
- When FDA Comes Calling, Do US Companies Fare Better Than Others? (Regulatory Focus)
- US: Medical Devices
- NIH Explains its New Data Sharing Policy (NIH) (NIH)
- CDRH: Legacy 510(k) Devices Need Cybersecurity Risk Assessments (MDDI)
- Texas judge tosses out 76 suits in J&J's ongoing vaginal mesh litigation (Fierce)
- EPA advisory panel's ruling could disrupt medtech (Mass Device)
- BrainScope Announces FDA Clearance of Ahead 100 Device for Adjunctive Assessment of Traumatic Brain Injury (Press)
- Boston Scientific Slammed With $18.5M Verdict In Mesh Trial (Law 360-$) (Fierce) (Bloomberg) (Mass Device) (Reuters)
- Majority of Android and iOS apps have been hacked, including FDA-cleared health apps (iMedicalApps)
- Lab Group Hires Super Lawyer to Fight FDA's LDT Regulation (GenomeWeb)
- FDA panel recommends approval of Alcon intraocular lens (Fierce) (Gray Sheet-$) (FDA)
- Should Medical Device Placebos be Used in Trials? (TIE)
- 5 Ways Firms Can Use QSIT For Internal Quality Audits (Silver Sheet)
- FDA needs to develop a better road map to help manufacturers make connected medical devices safer, more secure (MedCityNews)
- Upton: 21st Century Cures Act Will "Speed Up Approval for All Drugs and Devices" (E&C) (1:00 in)
- Second Sight CEO Greenberg: Next-gen 'bionic eye' could treat nearly all forms of blindness (Mass Device)
- Class I Recall for Baxter's INTRAVIA Empty Containers with PVC Ports – Particles Found in Patient Solution (FDA)
- Registration Deadline for Devices Coming up Soon (FDA)
- Ventilator Recalled Over Potential Power Failure (FDA)
- Drug Treatments for Asthma and Chronic Obstructive Pulmonary Disease that Do Not Use Chlorofluorocarbons (FDA)
- Pallone Picked as Top Democratic Member on the House Energy and Commerce Committee (The Hill) (CQ) (BioCentury)
- Burgess to Serve as House Energy and Commerce Subcommittee Chairman in the 114th Congress (Press)
- FDA says expects China to OK staff visas after two-year delay (Reuters) (ECN) (Bloomberg)
- FDA Weekly Enforcement Report (FDA)
- How Far Does FDA’s Say-So Travel? (FDA Law Blog)
- MDMA Founding Chair Tommy Thompson Dies At 76 (Fierce)
- Philips Healthcare Announces Recall of Children’s Medical Ventures Gel-E Donut / Squishon 2 Products (FDA)
- Class I Recall for Walker/Rolling Chair (FDA)
US: Medical Devices: Study Results, Filings and Approvals
- 510(k) for CAPRI Corpectomy Cage System (Press)
- 3Shape Implant Studio receives FDA 510(k) market clearance (Dentistry iQ)
- Kubtec Announces FDA Approval of the Highest Resolution Low Dose Portable Digital Radiography System for NICU (Press)
- AZE Technology, Inc. Announces FDA Approval of Phoenix (Volume Registration Viewer) (Press)
- Boston Scientific's Synergy Stent performs well in pivotal clinical trial (Fierce)
- Boston Scientific Touts Synergy Bioabsorbable Polymer Stent Trial Data (Gray Sheet-$)
- DOD-backed BrainScope wins FDA clearance for traumatic brain injury diagnostic (Fierce)
- IlluminOss wins FDA nod for bone fracture device trial (Mass Device)
- Aurora Spine Receives FDA 510(k) Clearance for Pre-Packaged Sterile ZIP 51 MIS Interspinous Fixation Implant (Press)
- September 2014 PMA Approvals (FDA)
- Roche nabs FDA clearance for quick strep test (Fierce)
- Valeant Pharmaceuticals And IDEAL IMPLANT Announce FDA And Health Canada Approval To Market Ideal Implant For Cosmetic Breast Augmentation (Press)
- Brain tumor treatment device gets early trial halt for efficacy as a combo with chemo (Fierce)
- Covidien study: VenaSeal effective in treating leg veins (Mass Device)
- Study: Stent patients benefit from long-term blood thinners (Mass Device)
- AdvanDx Receives FDA 510(k) Clearance for mecA XpressFISH (Press)
- Aurora Spine Receives FDA 510(k) Clearance for Pre-Packaged Sterile ZIP 51 MIS Interspinous Fixation Implant (Press)
- Data Shows the CardioMEMS HF System Significantly Reduced 30-Day Hospital Readmission Rates (Press)
- Argon Medical's CLEANER XT and CLEANER 15 Rotational Thrombectomy Systems Receive FDA Clearance for Mechanical Declotting and Infusion in the Peripheral Vasculature (Press)
- Syneron Candela Expands Capabilities of UltraShape Non-Invasive Fat Destruction Platform, Receives FDA Clearance for the New U-Sculpt Transducer and Enhanced Ultrasound Power (Press)
Ebola Outbreak
- U.S. seeking ways to speed blood samples from remote areas for Ebola tests in Liberia (WaPo) (Reuters)
- Device Maker Says Ebola Patient Recovered After Blood Filtration (Xconomy)
Europe
- NICE aims for earlier cancer diagnosis (Pharmafile) (Pharma Times)
- In, on and near body networks EU regulation (MDL)
- UK Data Protection Regulator Surveys Use of Smart Medical Devices (Inside Medical Devices)
- How to get a headstart with clinical evidence requirements for new EU IVD Reg (Clinica-$)
- Covidien Achieves CE Mark for the Nellcor Bedside SpO2 Patient Monitoring System, PM100N (Press)
- Two Affy Partners Launch Tests in Europe, Intensify Talks with FDA to Bring Dxs to US (GenomeWeb)
- IntriCon Receives CE Mark for Hearing Aid Products (Press)
India
- DoP sets up Task Force to identify issues relating to promotion of local production of high end medical devices (PharmaBiz)
Japan
- Deregulation at heart of Japan's new robotics revolution (Reuters)
Canada
- Canada set to go electronic for high-risk device applications (Clinica-$)
Other International
- For endorsement at the 19th AHWP Meeting-PROPOSED FINAL document on "Role of Standards in the Assessment of Medical Devices" (AHWP)
- For endorsement at the 19th AHWP Meeting in Seoul - PROPOSED FINAL document on "Amendment 3 to the Asian Harmonization Working Party House Rules” (AHWP)
- For endorsement at the 19th AHWP Meeting-PROPOSED FINAL document on "Comparison between the Common Submission Dossier Template (CSDT) format and the GHTF Summary Technical Documentation (STED) formats for In Vitro Diagnostic Medical Devices" (AHWP)
Clinical Trials
- GlaxoSmithKline is testing mobile health sensors for clinical trials (MobiHealthNews)