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  • Regulatory NewsRegulatory News

    CDRH Issues Guidance on Brain-computer Interface Devices

    Brain-computer interface (BCI) devices for patients with paralysis or amputation snagged the first leapfrog guidance from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) of the year, with new draft nonclinical and clinical recommendations. CDRH released the 42-page draft guidance document on Friday to provide new recommendations on Q-submissions and investigational device exemptions (IDEs) of implanted BCI devices for patien...
  • Regulatory NewsRegulatory News

    FDA Warns Against Using Implanted Pumps With Unapproved Drugs

    The US Food and Drug Administration (FDA) on Wednesday warned physicians against using implantable pumps to deliver pain medications directly into patients’ spinal fluid with drugs they were not approved for use with.   Using drugs that have not been approved for compatibility with the pumps could lead to dosing errors, pump failure, opioid withdrawal, infection, fever, vomiting, muscle spasms, cognitive changes and cardiac or respiratory distress, FDA says.   “The...
  • Regulatory NewsRegulatory News

    Health Canada Drafts Policies on 3D-Printed Implantable Devices

    Health Canada released draft guidance Thursday to aid manufacturers in preparing license applications for implantable medical devices produced by additive manufacturing or 3D-printing.   The guidance “represents the first phase of 3D-printing policy in Canada” because Health Canada intends to continuously adapt its policies to emerging issues on the topic “due to the fast-changing technological environment,” the regulator said.   3D-printed medical devices may be s...
  • Regulatory NewsRegulatory News

    Does FDARA Open the Door to Third-Party Reviews of Implantable Devices? Lawyer Discusses

    Thanks to the new user fee legislation known as the FDA Reauthorization Act (FDARA), the Food, Drugs and Cosmetics Act (FDCA) has been amended to allow for third-party reviews of Class II devices intended to be permanently implantable, life-sustaining or life-supporting. But which devices will be allowed such third-party reviews and what will be the implications? That decision will come from FDA, which has to issue guidance on the topic sometime in the next two ...
  • Regulatory NewsRegulatory News

    FDA Warns of Serious Risks for Syringe Pumps at Low Infusion Rates

    The US Food and Drug Administration (FDA) on Thursday issued a warning to healthcare providers over serious adverse events tied to programmable syringe pumps when set to deliver drugs at lower volumes, especially for infants and critically ill patients. In response, FDA has provided manufacturers of the devices with new language to add to their instructions for use that includes a list of warnings and considerations to mitigate the risks. The agency also says that ...
  • Regulatory NewsRegulatory News

    UK’s MHRA Cautions Diabetics on Roche’s Leaky Insulin Cartridges

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday said that patients with diabetes using Roche’s Accu-Chek Insight insulin pump should be careful when inserting pre-filled insulin cartridges as Roche has reported an increasing number of instances when patients experienced leaking insulin cartridges. “Users of Accu-Chek Insight insulin pump system with NovoRapid PumpCart cartridges, can check for any leaked insulin in the cartridge compartment...
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    NIST Kicks Off Wireless Infusion Pump Cybersecurity Project

    The National Institute of Standards and Technology (NIST) is launching a project to improve the cybersecurity of wireless infusion pumps. To do so, NIST's National Cybersecurity Center of Excellence (NCCoE) is looking for vendors to provide it with the components and technical expertise required to simulate the hospital environment in which infusion pumps operate. In a notice published in the Federal Register Monday, NIST said the goal of the project is to help health...
  • Regulatory NewsRegulatory News

    Australia’s TGA Cites Medical Device Batteries as a Growing Concern

    Australia’s Therapeutic Goods Administration (TGA) is calling attention to medical device battery issues, particularly for implantable devices, and saying manufacturers and health facilities should adopt procedures to reduce risk. A battery-related problem was listed as a potential contributing factor in more than 50 adverse event reports over the past 10 years involving deaths or serious injuries, the Australian regulator said, noting a range of safety alerts over the p...
  • Regulatory NewsRegulatory News

    Boston Scientific Ordered to Pay Surgical Costs for Faulty Pacemakers

    A prominent European court has ruled that Boston Scientific’s German branch is responsible for paying the surgical costs associated with replacing faulty implantable devices made by one of the company’s subsidiaries. In 2005, Guidant Corporation – which was acquired by Boston Scientific in 2006 – informed doctors it had identified potentially faulty components in three of its implantable products, two pacemakers and an implantable cardioverter defibrillator. Main Proc...
  • Infusion Pump Maker Warned About Alarm Problems

    • 30 August 2012
    The U.S. Food and Drug Administration (FDA) issued a warning letter to Hospira, Inc., about problems with alarm systems in its infusion pumps, according to a Reuters report. Hospira said the letter does not restrict production or shipping of the pump from its plant in Costa Rica. A spokeswoman for the company said it was changing components in the pump and expected to be done by early 2013. FDA's letter said the agency received complaints about the Plum brand infusion p...