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

Health Canada is developing guidance to help devicemakers seeking to license 3D-printed medical devices. Source: The GMP Letter

Zimmer Biomet’s Warsaw, Indiana orthopedic implant manufacturing facility drew a warning from the FDA for quality violations dating back to 2016 after an April inspection revealed ongoing problems. Source: The…

The FDA hit seven devicemakers for a range of GMP and other violations observed during agency inspections. Source: The GMP Letter