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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 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
The European Association for Medical Devices of Notified Bodies (Team-NB) is sounding alarms over the shortage of notified bodies to conduct audits and certify devicemakers in time to comply with the new European medical device regulations. Read More
Otsuka America Pharmaceuticals told the IG it wanted to use a smart phone app to help ensure that patients took Abilify on time and correctly. Read More
The agency intends to identify the types of devices that qualify for review, as well as the performance characteristics needed for clearance. Read More
Some of the firm’s device history records didn’t document that the devices were manufactured with the correct parts or correct number of parts. Read More