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:…

FDA officials welcomed a risk-based approach to CAPA systems during a session at 2017 RAPS Regulatory Convergence, but cautioned that each CAPA investigation is unique. Source: The GMP Letter

Brazil’s National Agency for Sanitary Surveillance is streamlining its process for good manufacturing practice certification to allow faster access to new technologies. Source: The GMP Letter