Devices & Diagnostics Letter

Former executives of orthopedic devicemaker Synthes drew prison sentences for clinical trial rule violations that killed three people.

The Asia-Pacific Economic Cooperation (APEC) forum has agreed on a strategic plan to align regulatory approval procedures for medicines and medical devices by the end of the decade.

Besides lacking key information on confidentiality, a draft guidance on pivotal studies for premarket applications poses impossible barriers for trial managers and seems to imply the FDA prefers randomized studies over other trial designs, according to comments on the document.

The FDA has warned a California eye care facility for continued failure to document medical device reporting (MDR) procedures.

American X-ray equipment firms soon could be selling Chinese customers newer technology under an accord reached at the 22nd U.S-China Joint Commission on Commerce and Trade.

CooperVision’s recent expansion of a contact lens recall will have long-term negative effects only if FDA investigations turn up other significant problems, contact lens consultant Ralph Stone said in a Nov. 16 Wells Fargo Securities conference call.

Knowledge of sterilization failures and failure to remedy them were among violations at Bayamon, Puerto Rico-based Biolab, an FDA Form 483 and subsequent warning letter say.

The FDA should adopt persuasive communication techniques to steer the public away from public health risks when it believes hazards are real and avoidable, an advisory panel says.

A House Democratic leader is trying to create a “three-way street” to encourage dialogue between devicemakers, FDA officials and Congress.

FDA investigators closed an inquiry into a Virginia devicemaker based on the company’s corrective actions, a June 8 closeout letter says.