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Device Regulation Alert: Safety, Compliance and Reimbursement News Pharma Compliance Alert

Device Regulation Alert: Safety, Compliance and Reimbursement News

Published weekly, this free e-newsletter offers up-to-date information on hot topics and trends effecting the medical device and diagnostics industry. With a subscription to Device Regulation Alert, you will get comprehensive coverage of device regulation, compliance and risk management.

2009 | 2008 | 2007

Issue 15, May 9, 2009

• Editor's Note: Final issue of Device Regulation Alert today

  HCPro is sorry to announce that this is the final issue of Device Regulation Alert. We thank you...

• Device maker settles allegations it failed to disclose payments to physicians

  Medical device maker Synthes, Inc., based in West Chester, PA, entered into a settlement agreement...

• Disetronic Medical Systems recalls insulin pumps

  Disetronic Medical Systems issued a recall for its ACCU-CHEK Spirit insulin pumps with serial...

• FDA sends warning letter to Nidek Medical Products

  Nidek Medical Products failed to properly document complaints about the company's oxygen...

• IOM calls for end to industry support

  The Institute of Medicine (IOM) became the latest organization to call for an end to medical device...

Issue 14, April 27, 2009

• Third former device employee pleads guilty to misbranding

  Shane Doyle, 32, of Winchester, MA, pleaded guilty to felony misbranding, according to the...

• St. Jude warned about manufacturing problems

  St. Jude Medical received an FDA warning letter citing manufacturing problems mainly related to the...

• Biomet under investigation for possible fraud

  Government investigators are examining allegations that Biomet improperly sold, promoted, and...

• Smith & Nephew receives subpoena from DOJ

  The Department of Justice subpoenaed documents relating to Smith & Nephew’s ultrasound...

• Quest to pay $302M for subsidiary's alleged misbranding

  Quest Diagnostics and its subsidiary, Nichols Institute Diagnostics (NID) will pay $302 million to...

• Arrow recalling intra-aortic balloons

  Arrow International recalled 45,211 units of volume connectors for its 30-, 40- and 50-cc...

• Business associates: HIPAA survey

  We want to hear from business associates about their need for HIPAA training. Business associates...

Issue 13, April 13, 2009

• FDA to review risks for older devices

  Manufacturers of 25 types of medical devices marketed prior to 1976 must submit safety and...

• Massachusetts disclosure requirements a first for medical device manufacturers

  Massachusetts is the first state to require medical device companies to disclose financial...

• Johns Hopkins bans gifts

  A new Johns Hopkins Medicine (JHM) policy prohibits physicians, scientists, students, and staff...

• Stanford to disclose payments from device makers

  Stanford University School of Medicine will reveal which of the 1,200 physicians and faculty...

• ZOLL issues corrective action for automated external defibrillators

  ZOLL Medical Corporation initiated a voluntary field corrective action for 180,000 ZOLL AED Plus...

• Charges dropped against four device makers after DPAs expire

  The Department of Justice (DOJ) dropped criminal conspiracy charges against Zimmer, Depuy...

• FDA: Medtronic voluntary recall of catheter is Class I recall

  The FDA is classifying Medtronic’s voluntary recall for three models of the BioGlide...

Issue 12, March 30, 2009

• Judge dismisses suit against Allergan citing preemption

  A federal judge cited the February 2008 Supreme Court ruling in favor of preemption for medical...

• FDA issues draft guidance on user fees

  New FDA draft guidance includes user fee and user-fee refund information for 30-day notices and...

• Groups agree on clinical credentialing standard

  AdvaMed and 10 other healthcare organizations are working together to create national standards for...

• Boston Scientific settles patent dispute

  Boston Scientific will take a $50 million pre-tax charge to its earnings to settle all outstanding...

• Welch Allyn recalls external defibrillators

  Welch Allyn’s AED 10 and MRL JumpStart external defibrillators may experience low energy...

Issue 11, March 16, 2009

• Editor's Note

  Beginning with this week’s issue, Device Regulation Alert will be published every other week...

• Massachusetts finalizes disclosure regulations

  The Massachusetts Public Health Council (PHC) finalized regulations March 11 governing the sales...

• Stryker under investigation for alleged illegal promotion

  A Massachusetts grand jury is investigating a Stryker subsidiary’s promotion of its human...

• FDA issues warning about transdermal patches and MRI

  Transdermal drug patches with metallic backing can overheat during an MRI scan and cause skin burns...

Issue 10, March 9, 2009

• Congress aims to eliminate preemption of state lawsuits

  One day after the US Supreme Court ruled FDA approval does not shield pharmaceutical companies from...

• DOJ investigating Medtronic marketing

  The Department of Justice (DOJ) is investigating Medtronic’s promotion of its cardiac...

Issue 9, March 2, 2009

• Medtronic to disclose payments for physicians

  Medtronic is taking another step towards transparency by voluntarily disclosing payments to...

• Cardinal Health modifies consent decree with FDA

  Cardinal Health will thoroughly review all of its infusion pump products within 60 days and submit...

Issue 8, February 23, 2009

• Wisconsin Supreme Court sides with Medtronic

  FDA approval preempts patients’ rights to sue medical device manufacturers for potentially...

• Non-profit group criticizes FDA for ignoring GLPs

  The FDA is putting patient lives at risk by failing to enforce good laboratory standards (GLPs...

Issue 7, February 16, 2009

• NeuroMetrix resolves kickback allegations

  Device maker NeuroMetrix, based in Waltham, MA, agreed to pay a $1.2 million criminal fine to...

• Device sales rep pleads guilty to misbranding

  Justin Demming, of Wadsworth, OH, pleaded guilty to felony misbranding of a medical device...

• FDA's final guidance clarifies reprint guidelines

  In January, the FDA provided some much needed guidance for the medical device industry about when...

Issue 5, February 2, 2009

• InnoMed receives FDA warning letter for alleged GMP violations

  InnoMed failed to abide by current Good Manufacturing Practices (GMPs) at its Coconut Creek, FL...

• Spine society adopts disclosure policy

  Physicians participating in North American Spine Society (NASS) activities will have to disclose...

• Transparency coming to Harvard

  Harvard Medical School could follow the example of Stanford University, the University of...

• FDA releases updated draft guidance for ANA test systems

  New developments for in vitro diagnostic devices prompted the FDA to release a revised guidance...

• Credible reports of compliance violations come from walk-ins

  Employees who walk in to the compliance officer’s office to report a suspected compliance...

Issue 4, January 26, 2009

• Senators reintroduce disclosure law

  Senators Charles Grassley (R-IA) and Herb Kohl (D-WI) continue to push for national legislation...

• Minnesota health system to require disclosure of industry ties

  Park Nicollet Health Services, located in Minnesota, will begin requiring physicians to disclose...

• Class III devices may require PMA

  Medical device manufacturers may soon be required to submit all class III devices to the more...

Issue 3, January 19, 2009

• Device maker sues physician for slander

  NMT Medical, a Boston medical device manufacturer, filed suit against British researcher Dr. Peter...

• Medtronic paid researcher $19M

  Senator Charles Grassley (R-IA) continues to scrutinize payments from medical device makers to...

Issue 2, January 12, 2009

• Judges dismisses cases against Medtronic

  U.S. District Judge Richard Kyle dismissed dozens of patient lawsuits against Medtronic, saying the...

• FDA issues guidance on enterovirus nucleic acid assays

  Any firm that submits a 510(k) for enterovirus nucleic acid assays must show that its device...

Issue 1, January 5, 2009

• AdvaMed updates Code of Ethics

  AdvaMed further clarified what constitutes appropriate interactions between the medical device...

• Edwards Lifesciences to disclose physician payments

  Edwards Lifesciences will begin voluntarily disclosing payments to physicians this year, according...