The US Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the ...
The US Food and Drug Administration (FDA) has issued a new final guidance document intended to clarify the process by which manufacturers of "custom" medical devices can comply with federal ...
The Food and Drug Administration Tuesday issued a final rule that updates the definition of a custom device to include new statutory requirements and procedures. Under the provision, custom medical ...
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