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Routine quality system surveillance inspections of foreign devicemakers increased by 93 percent in 2012, according to newly released FDA data. Overall QS inspections were up 37 percent for the year. Read More
There has been a steady uptick in the number of FDA 483s that cite inadequate supplier controls — from 84 in 2011, to 110 in 2012 and 126 last year. The problem is now one of the top five most common 483 findings for devicemakers. Read More
CINCINNATI — With September’s deadline for displaying unique device identifiers on high-risk devices just around the corner, rollout for many manufacturers is well underway. Read More
Lawyers are advising devicemakers working on the conflict mineral reports due to the Securities and Exchange Commission in June to put more effort into describing their compliance with the Organisation for Economic Co-operation and Development’s due diligence guidelines. Read More
A rise in whistleblower lawsuits involving off-label marketing of medical devices has sparked increased scrutiny by the FDA, and the suits are not likely to stop anytime soon, experts say. Read More
Healthcare professionals are calling on the European Parliament and the Council of the European Union to relax genetic counseling requirements in the current draft of the In Vitro Diagnostic Device Regulation, saying they will restrict patients’ right to essential testing. Read More
GOP senators are criticizing the FDA for implementing policy via draft guidance instead of rulemaking, and are clamoring for answers on how long it takes the agency to finalize its guidance documents. Read More
Government and industry stakeholders at a public workshop on health IT found plenty of agreement, but few concrete proposals for a path forward. Read More
A chief architect of a 2007 law promoting the development of medical devices for children has asked the FDA to provide evidence it is making progress on meeting its goals. Read More
San Diego devicemaker Dr. Joel Kaplan, Inc., received an FDA warning letter for off-label claims about its penis pumps, including advertising the devices online to fix penile curvature. Read More
Devicemakers often misuse voluntary consensus standards in premarket submissions, the FDA says, by using versions of standards that the agency doesn’t recognize or using consensus standards that don’t apply to their specific device or testing methods. Read More