Johnson & Johnson is facing lawsuits in two states that allege the company engaged in deceptive marketing claims for “new and revolutionary” surgical mesh used to treat women with pelvic…

Renovis Surgical Technologies received a strong warning from the FDA over its failure to conform to quality system regulations covering design verification, process validation, product development requirements and risk analysis.…

The FDA issued Grams Medical a warning letter for sterilization problems related to its reusable cannula tips. Source: The GMP Letter

The European Commission has published an updated version of harmonized standards that devicemakers and diagnostics makers can reference to ensure their products comply with relevant EU legislation. Source: The GMP…

In the ongoing Theranos saga, the company has now rescinded test results from the past two years for its Edison blood-testing diagnostics. Source: The GMP Letter

The Senate HELP Committee unanimously advanced to the full Senate a bill that would give the FDA additional tools to review and ensure the safety of medical devices, such as…

Device manufacturer Moss Tubes has been cited for multiple alleged reporting violations tied to product failures, one of which apparently resulted in a patient death. Source: The GMP Letter

Arkray is recalling certain test strips due to inaccurate blood sugar readings. Source: The GMP Letter

Sientra is planning to return all of its medical devices — including breast implant products — to the U.S. market starting March 1. Source: The GMP Letter

Dräger is recalling 117 emergency transport ventilators due to a system error that may lead to a halt in ventilation therapy. Source: The GMP Letter