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The UDI Rule requires a device to bear a UDI on its label and packages. Special labeling requirements apply to ...
Last week, the FDA finalized guidance for medical device establishment inspections, which satisfies a requirement ...
FDA released a guidance document on Monday in the form of a question and answer format to help the industry ...
The COVID-19 pandemic has forced some of the most drastic loosening of regulatory requirements the FDA has ever ...
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