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Facilities in India, Lithuania and Texas drew warnings from the FDA for a variety of noncompliances, including inadequate validations, designs and device history records. Read More
The recent ransomware attacks in the U.S. healthcare industry have highlighted the need for increased product security for medical devices, the American Hospital Association said in a letter to the FDA. Read More
CDRH is looking to enroll a total of nine participants in its new pilot program aimed at identifying best practices for quality product manufacturing. Read More
Heath Canada intends to begin piloting the use of its Regulatory Enrollment Process through the Common Electronic Submission Gateway for medical device applications by this summer. Read More
New draft regulation spells out qualification requirements for medical reps, including a two-year junior college degree or higher with a major in life sciences. Read More