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The FDA said in a new draft guidance a “least burdensome” approach should be applied throughout the medical device total product lifecycle, rather than just in premarket activities.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
FDA Commissioner Scott Gottlieb said the agency’s least burdensome approach policy approach is “a hallmark of our efforts to help innovators generate… 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