Notified Bodies Warn of Future Bottlenecks in Implementing New Device Regs
The European Association for Medical Devices of Notified Bodies (Team-NB) is sounding alarms over the shortage of notified bodies to conduct audits… Read More
Routine Inspections Suspended During Partial FDA Shutdown
Some of the FDA’s regulatory and compliance activities — including routine inspections — were placed on hold because of the partial government shutdown that began on Dec. 22 and continued into the new year. Read More
Devices News
CDRH Seeks Stakeholder Input on 2019 Guidance Priorities
FDA’s Center for Devices and Radiological Health called for feedback from stakeholders on its priorities for developing guidance for the year ahead. Read More
Health Canada Maps Out Action Plan to Improve Device Safety, Quality
Health Canada released a three-part action plan aimed at improving how devices get on the market, strengthening monitoring and providing more information to consumers about the devices they use. Read More
Zevex Cited for Inadequate CAPA, Nonconforming Product Rework
Inadequate corrective and preventive action procedures and improper procedures for rework of nonconforming product landed devicemaker Zevex in hot water with the FDA following a Sept. 4 to Sept. 17 inspection of its Salt Lake City, Utah ... Read More
Wound Dressing Manufacturer Falls Short on Quality Requirements
Devicemaker Winfield Laboratories was unable to produce quality control documentation for its N-Terface dressing, a Sept. 24 to Sept. 25 FDA inspection of the Richardson, Texas, facility revealed. Read More
