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FDA: Annual Reports for Approved PMA FDA

FDA: Annual Reports for Approved PMA

The Food and Drugs Administration (FDA), the US authority responsible for medical device regulation, has published a guidance document dedicated to the annual reports for Pre-market Approval Applications (PMA) that have been approved. Regulatory Background  According...

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FDA Voluntary Consensus Standards FDA

FDA Voluntary Consensus Standards

The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, allows the manufacturers to use national and international voluntary consensus standards when preparing and evaluating premarket submissions for medical devices. ...

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