Canada is working with Bayer to update labels and increase monitoring of its Essure birth control implant. Source: The GMP Letter

The World Health Organization has published a model regulatory guidance for medical devices and IVDs intended to support developing nations that have yet to develop regulations covering medical devices. Source:…

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

IsoLux has earned a warning letter from the FDA for several procedural failures related to its A/C powered illuminators. Source: The GMP Letter

The FDA cited a diabetes device data firm for alleged procedural failings in a recent FDA Form 483. Source: The GMP Letter

Cook Medical is recalling 408,011 of its Beacon Tip Catheter in U.S. markets, due to complaints that the catheter tip may split or separate and could potentially enter the patient’s…

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