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 CDRH released the 42-page draft guidance document on Friday to provide new recommendations on Q-submissions and investigational device exemptions (IDEs) of implanted BCI devices for patien...

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...

Health Canada released draft guidance Thursday to aid manufacturers in preparing license applications for implantable medical devices produced by additive manufacturing or 3D-printing.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...

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 ...

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...

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...