The FDA issued warnings to three device manufacturers for failures in GMPs, validations, MDRs, and other quality-related issues. Source: The GMP Letter

Repro-Med Systems in Chester, N.Y. failed to submit a report to the FDA on steps taken to reduce a health risk posed from a device, inspectors found during a late…

Some devicemakers can be slow to recognize trends in medical device complaints. It’s not enough to have a solid complaint handling system when regulators expect you to learn something from…

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…