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Medical device software can be vulnerable to cyber threats, “especially if the device is older and was not built with cybersecurity in mind,” the agency has said. Read More
The FDA said it was proposing to refuse Intarcia Therapeutics’ drug-device combination product, ITCA 650, for continuous release of the type II diabetes drug exanatide. Read More
Abbott Laboratories’ CardioMEMS implantable heart failure monitor missed the primary endpoint in an expanded patient population, but the company said that COVID-19 may have skewed the results. Read More
The FDA is getting back its rulemaking authority, which was significantly weakened under President Trump, as the Biden administration reverses multiple policies from the previous administration. Read More
The FDA issued an update on which types of devices may be offered as over the counter (OTC) devices and what devicemakers should consider when making the switch from prescription to OTC status. Read More
Changing a 510(k)-cleared device labeled for prescription use only to a device labeled for OTC use would likely require a new premarket submission, the FDA said. Read More
Australia’s Therapeutic Good Administration has begun a postmarket review of all continuous and non-continuous ventilators, acute care ventilators, ambulatory ventilators including positive airway pressure (CPAP) devices and bi-level positive airway pressure (BiPAP) devices on the Australian Register of Therapeutic Goods (ARTG). Read More
Australia’s Therapeutic Goods Administration (TGA) has released updated guidance on new regulations for software-based medical devices that became effective in February 2021. Read More
Remote audits are turning up roughly the same number of non-conformities as seen in onsite audits, a majority of EU notified bodies said in response to a survey. Read More
Reports of a vulnerability in the Blackberry operating system used in certain medical devices and device manufacturing equipment as well in pharmaceutical manufacturing equipment has prompted the FDA to issue a cybersecurity alert. Read More
Health Canada issued a notice explaining how it classifies ultraviolet (UV) light-emitting decontamination products making COVID-19 claims and the pathways for market authorization. Read More
Australia’s Therapeutic Goods Administration (TGA) is requiring manufacturers of permanently implantable devices to provide patient implant cards and consumer device leaflets with their devices. Read More