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Q3 Product Recalls Tip U.S. Further into Record-Breaking Year

Product recall claims

The number of products recalled this year has officially reached a 20-year high, according to third-quarter recall data from the United States.

FDA Planning to Require Cybersecurity Checks in Medical Device Submissions

Gynecologist prepares for surgery in operating room, Ultrasound medical device

While the FDA has addressed threats to networked medical devices through its guidance and product evaluations, the agency should take more steps to fully integrate cybersecurity into its premarket reviews, according to an HHS report. The HHS inspector general’s office recommended the FDA and manufacturers use presubmission meetings to better address cybersecurity-related questions, and that… Continue reading FDA Planning to Require Cybersecurity Checks in Medical Device Submissions