Devices & Diagnostics Letter

The senators who co-authored the Physician Payments Sunshine Act are trying once more to exercise their legislative oversight — this time setting a June deadline for overdue implementation of the rules.

Recent agency data show CDRH making slow but steady progress toward several strategic goals — though announced plans to expand the MedSun program appear to be on hold.

Makers of cranial electrotherapy stimulators (CES) are crying foul in the wake of an FDA advisory panel meeting that ruled against reclassifying the devices.

The EU’s Scientific Committee on Emerging and Newly Identified Health Risks will prepare a questionnaire for women who received the PIP silicone gel breast implants, to be distributed by member states.

A Memphis, Tenn., diagnostics firm has been slapped with an FDA warning letter after an inspection found multiple quality and complaint-handling problems throughout the facility.

Devicemakers should have an easier time filing field safety and corrective action (FSCA) reports in the EU, thanks to new report forms in a revised guideline on medical device vigilance systems.

Devicemakers may need to pay more attention to the design of alarms on their products as CDRH concern rises over so-called “alarm fatigue.”

The FDA has escalated a long-simmering dispute with Israeli-owned software developer NeuroTrax about the proper classification of its MindStreams cognitive health assessment tool, telling the company in a warning letter it must seek Class III status or halt marketing the product.

The standard cost of requesting classification information from the FDA has been set at $3,462 for fiscal 2012, a newly finalized guidance states.