This Week in Medical Device Regulation (3-7 November 2014)

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

Regulatory Focus:

• FDA Will Soon Need to Publish More Information About the Outside Standards it Uses (Regulatory Focus)
• FDA Looking for a Leader for its New Device Testing Division (Regulatory Focus)
• Is FDA Listening Enough to Patients? Agency Wants Feedback (Regulatory Focus)
• ANVISA Allowing Automatic Deadline Extensions for Medical Device Registrants (Regulatory Focus)

US: Medical Devices

• Stryker Settles Suits by Hip Implant Patients for $1 Billion (NYTimes) (Reuters) (Mass Device) (Press) (Bloomberg)
• Government watchdog promises to monitor device cybersecurity in FY 2015 (Fierce)
• Medical firm profited on pain with knockoff spine surgery hardware (CIR)
• Dozens of lawsuits filed in growing counterfeit spinal screw implant scandal (Fierce)
• Boston Scientific faces first federal transvaginal mesh trials (Reuters) (Reuters)
• J&J Could Pay $250M To Settle More ASR Hip Implant Suits (MedDeviceOnline)
• FDA Sued Over Detained Chinese Leg Braces (Law 360-$)
• How To Address The Top 3 Supplier Management Issues (MedDeviceOnline)
• How to Classify a Mobile Medical App and Submit It For FDA Approval or Clearance (MDDI)
• Securing Medical Devices: FDA Guidance and its Implementation (PCM)
• Small Device Maker Fights FDA on ‘Grandfather’ Claim (MDDI)
• How to Design for Compliance: Tips for Getting (and Keeping) Your New Product on the Market (GxP Lifeline)
• Don’t Be Haunted By Making Poor Post-Market Surveillance Choices (Silver Sheet-$)
• FDA Webinar on Distinguishing Device Recalls from Enhancements (FDA)
• Notices About Lack of UDIs Now Showing Up in FDA Recall Notices (FDA)
• Recall for Hospira Power Supply That Doesn't Deliver Enough Electricity (FDA)
• Class 1 Device Recall Baxter 2B8011 Empty INTRA VIA Container with PVC Ports (FDA)

US: Medical Devices: Study Results, Filings and Approvals

• FDA: Edap's Ablatherm prostate cancer device 'not approvable' (Mass Device)
• Ipsen Announces FDA Approval of a New Delivery Device for Somatuline Depot (lanreotide) Injection (Press)
• FDA Approves Dexcom Software with Artificial Pancreas Algorithm (Press)
• Medtronic in high spirits over positive study results for drug-coated balloon (Fierce)
• Covidien Announces Nine-Month Results of DURABILITY Iliac Study, Addition of Iliac Indication for EverFlex Stent System at VIVA 2014 (Press)
• ReShape finally reveals pivotal obesity data ahead of FDA review (Fierce)
• AtriCure Receives FDA Approval For Pivotal Study to Enroll Non-Paroxysmal Afib Patients (Press)
• Covidien’s HawkOne Directional Atherectomy System Receives FDA 510(K) Clearance for the Treatment of Peripheral Arterial Disease (Press) (Mass Device)
• Syneron Medical Says FDA Clears New PicoWay Picosecond Device (RTT)
• HyperQ High-Res ECG Technology FDA Cleared to Diagnose Heart Attacks (MedGadget)
• Paragonix Technologies Inc., Announces Filing of two 510(k) Pre-Market Notifications with the Food and Drug Administration (Press)

Ebola Outbreak

• Ebola patient who used bio-filtration device reportedly free of virus (MM&M)
• Researchers Seek Crucial Tool: A Fast, Finger-Prick Ebola Test (NYTimes)
• WHO toughens standards for Ebola protective gear (The Hill) (WHO)

Europe

• EU accelerates medtech regs push-through as Italian Presidency, MEPs take action (Clinica-$)
• MHRA vaginal mesh implants report: benefits of use outweigh risks (MHRA)
• Fresh look at plasticizers in devices: new EU opinion out for comment (Clinica-$)

China

• Watch out for China’s stricter clinical trial rules for hospitals, industry warned (Clinica-$)

Other International

• Surviving ISO 9001:2015 (GxP Lifeline)

General Regulatory And Interesting Articles

• Turn Your Birth Control On and Off With a Remote (Smithsonian)
• Wirelessly Charging Implanted Medical Devices (MedDeviceOnline)
• Blood pressure devices giving inaccurate readings, study finds (PharmJournal)
• Scientists seek to make remote-controlled drug delivery device that works in space (BioPharma Dive)
• Hopes for single blood test to detect many cancer types (PharmaTimes)

This Week in Medical Device Regulation is our weekly intelligence briefing for the regulatory affairs space, bringing you the top medical device regulatory news stories from around the globe. Each week, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the medical device industry.

Need to contact the editor? Find him on Twitter at @AlecGaffney or send him an email at [email protected].

A story's inclusion in This Week in Medical Device Regulation does not imply endorsement by Regulatory Focus or RAPS.