As the FDA expands its use of real-world evidence, medical device companies are starting to explore the benefits — and the challenges. Source: The GMP Letter

Citing post-market safety concerns about the delivery accuracy of infusion pumps, Health Canada is updating the evidence requirements to demonstrate the accuracy of these devices through performance testing for new…

Australia’s Therapeutic Goods Administration issued new guidelines on electronic instructions for use for medical devices. Source: The GMP Letter

The FDA extended the compliance date for Global Unique Identification Database (GUDID) submission requirements for combination products, giving devicemakers another year to comply. Source: The GMP Letter

The FDA issued a list of medical device accessories that it believes are safe and effective enough to be categorized as Class I and requested public feedback on the proposed…

The FDA is allowing manufacturers of combination products to submit certain device malfunction medical device reports on a quarterly basis. Source: The GMP Letter

The Global Diagnostic Imaging Healthcare IT & Radiation Therapy Trade Association is calling on the FDA and the Medical Device Single Audit Program consortium to review the program’s inconsistencies and…

Swiss Medic will overhaul the way it issues export certificates and manufacturing certificates for devices in the fall and introduce new fees that take effect on Jan. 1, 2019. Source:…

The FDA released new draft guidance for devicemakers on submitting premarket notifications for metal expandable biliary stents and their delivery systems. Source: The GMP Letter

The FDA hit six U.S. devicemakers with 483s for problems agency investigators observed in facility inspections including inadequate risk procedures, labeling and complaint handling. Source: The GMP Letter