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The FDA said in a new draft guidance a “least burdensome” approach should be applied throughout the medical device total product lifecycle, rather than just in premarket activities. Read More
The FDA finalized a more detailed “leapfrog guidance” on additive manufactured, or 3D-printed, medical technologies, outlining its latest thinking on technical considerations. Read More
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