CDRH and the Office of Regulatory Affairs would have to “reprioritize and reevaluate” device programs under the Trump administration’s proposed budget for fiscal 2018. Source: The GMP Letter

Australia’s Therapeutic Goods Administration will likely follow the FDA’s lead and the International Medical Device Regulators Forum’s model for regulating software for medical devices. Source: The GMP Letter

Two-thirds of medical devicemakers and about half of healthcare delivery organizations believe a cyber attack on a medical device built or in use by their organizations is likely to occur…

The FDA’s Office of Regulatory Affairs officially began its transition to a program-based structure on May 15, aligning inspection staff into seven product categories — and creating three new geographic…