Royal Philips agreed to enter into a consent decree with the U.S. Department of Justice to suspend production of its automated external defibrillators at two of its U.S. manufacturing sites.…

Health Canada has made significant changes to its Medical Device Single Audit Program with the goal of reducing audit times. Source: The GMP Letter

The FDA issued final guidance on when to submit a new 510(k) for a planned change to an existing device. Source: The GMP Letter

The FDA flagged device firms in the U.S., France, Germany, the United Kingdom, the Czech republic, and India for a range of issues, including MDR reports, CAPA failures and other…

The Department of Homeland Security issued a warning about two security vulnerabilities in Boston Scientific’s portable cardiac rhythm management systems. Source: The GMP Letter

The FDA proposed a framework for a voluntary pilot program aimed at using industry assessments of manufacturing quality to reduce the agency’s oversight actions. Source: The GMP Letter

Euro-Diagnostics, Kelyniam Global, Magellan Diagnostics and Pelvic Therapies drew warning letters from the FDA for a range of GMP and other failures. Source: The GMP Letter

The FDA announced the nine participants selected for its first digital health software pre-certification pilot program, ranging from startups to giants in the space. Source: The GMP Letter

Moving into 2018, CDRH is focused on two main objectives to change how inspections of medical device manufacturing facilities are conducted — the case for quality and program alignment. Source:…