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Latest Standards and Certification Update
Medical device manufacturers want the US Food and Drug Administration...
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FDA proposes medical device rule to simplify classification process
The US Food and Drug Administration (FDA) is proposing to amend its regulations governing classification and reclassification of medical devices to conform to provisions in the FDA...
Applied Silicone offers comprehensive material compendia for long-term implantable silicone products
Applied Silicone Corporation, a global supplier of implantable silicone material for the critical healthcare and medical device markets, announces the availability of material...
Study calls for repeal of tax
Just a few months after the implementation of the US medical device tax, and hot on the heels of much criticism for it, a new study has concluded the policy should be repealed.
Europe split on approvals
In March the European Commission and Parliament were reported to be in a disagreement over the possible introduction of central agency to oversee the approval of medical devices.