Devices & Diagnostics Letter

The FDA is planning to reorganize its Office of Regulatory Affairs (ORA), including creating new offices and reorganizing others, as it takes steps to dissolve cumbersome domestic and international distinctions and keep pace with increasingly global operations.

The FDA is in the last stages of finalizing a June 2011 guidance on classification of combination products, a senior FDA employee said Thursday.

The FDA is giving devicemakers an additional 45 days to comment on the collection of information associated with a unique device identifier (UDI) system.

The FDA’s draft guidance on the PMA acceptance process follows transparency and time goals outlined during recent FDA-industry Medical Device User Fee Act (MDUFA) negotiations and provides details that will help ensure a smooth and productive review, industry comments suggest.

Questions announced this month for a November meeting on the future of Medicare coverage for ventricular assist devices (VAD) appear to give devicemakers little to worry about, one analyst says.

The FDA’s Orthopaedic and Rehabilitation Devices Panel voted 16-0 Friday to recommend placing posterior cervical pedicle and lateral mass screws in Class II with special controls.

British researchers have failed to show a tie between metal-on-metal (MoM) hip implants and a cancer diagnosis in the first seven years after surgery, according to a report out last week.

The FDA Tuesday approved the first ultrasound device designed specifically to detect breast cancer in women with dense breast tissue.

Health Canada plans to shift health product monitoring to a total product lifecycle approach in the coming years, according to a new health product vigilance framework.

Manufacturers of transdermal patches should minimize the amount of residual drug substance in the patch as much as possible to avoid patient and environmental safety risks, according to a new European Medicines Agency (EMA) draft guideline.

In response to the rapid rise in counterfeits, the International Organization for Standardization (ISO) has issued a new industrywide standard to help ensure the lifecycle integrity of products.