Boston Scientific and Cook Medical questioned parts of the FDA’s guidance on premarket notifications for metal expandable biliary stents and their delivery systems — including limits on eligibility for the…

The FDA flagged six devicemakers for a variety of deficiencies including complaint handling, inadequate documentation and quality system failures. Source: The GMP Letter

CDRH issued a Sept. 27 memo to alert device manufacturers about a post-market safety issue concerning pen needles used with pen injectors. Source: The GMP Letter

The FDA released a proposed rule that would simplify the process for electronic premarket device submissions. Source: The GMP Letter

ITG-Medev failed to follow up on its promised solutions to nonconforming process validations and documentation of acceptance activities, the FDA said in a warning letter to the devicemaker. Source: The…

The FDA hit two Medtronic device facilities with warning letters last week, citing faulty device history records and CAPA procedures. Source: The GMP Letter

FDA Commissioner Scott Gottlieb said the agency has advised Congress to take a three-pronged approach to modernizing diagnostics standards. Source: The GMP Letter

The FDA needs to do more to ensure the cybersecurity of networked medical devices, according to a new report from the HHS Office of Inspector General. Source: The GMP Letter