FDAnews Device Daily Bulletin

The FDA last week got a preview of the comments it can expect in response to its unique device identifier (UDI) draft rule ranging from whether a change in UDI would require a new supplemental PMA or 510(k) to questions about date formatting required by the rule.

Makers of Class IV devices that choose not to use a summary technical documentation (STED)-based license or amendment application must provide details on manufacturing and quality controls, a device-specific quality plan and process validation studies, according to a Health Canada final guidance.

A medical device manufacturer with a 3-D CAT scanning device that takes pictures of patient’s feet from a standing position is seeking regulatory approval in Europe.

A device that measures someone’s unique response to a weak electric signal could let medical devices such as blood-pressure cuffs automatically identify the wearer and send measurements straight to his or her electronic medical record.

Fear of going to the dentist is extremely common — according to the American Dental Association, more than 20 percent of Americans are too afraid even make an appointment.

Boston Scientific is cutting 50 jobs from its Galway, Ireland, operations.

NeuroMetrix said its Sensus pain management device has been approved by the Food and Drug Administration.

The University of Minnesota’s Medical Devices Center has filed 109 invention disclosures since it was established in spring 2008.