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The number of medical devices recalled in the U.S. during the final quarter of 2014 increased over the previous quarter despite an overall drop in the number of recall actions, a report from Stericycle Expert Solutions shows. Read More
Devicemakers should submit new electronic Medical Device Reports several days before the deadline or risk being considered late under U.S. FDA requirements that take effect Aug. 14. Read More
Devicemakers whose instructions for use are flawed or poorly written could see them flagged by the UK’s Medicines and Healthcare products Regulatory Agency as adverse events. Read More
Devicemakers doing business in the Czech Republic face a steeper regulatory burden than before, thanks to regulations that took effect April 1. Read More
The EU was set to sign on as a full observer to the International Medical Device Regulators Forum’s single audit program when the group met in Tokyo in late March, according to an FDA official familiar with the talks. Read More
The U.S. FDA has chosen a veteran public health officer to spearhead its device postmarket surveillance programs. Gregory Pappas joined the agency in February as associate director for national device surveillance in the Center for Devices and Radiological Health’s Office of Surveillance and Biometrics.
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Women’s healthcare device manufacturer CooperSurgical received a Form 483 for failure to initiate corrective action for a process failure associated with its Blunt Hurd Cannula-Blunt Tip 10mm with 5mm Reducer. Read More