This procedure outlines basic controls required for all Internal Use Only information (IUO), including paper files and IT devices, systems processing, storing, or transmitting Internal Use Only.
Among potential changes is that manufacturers will have to anticipate customers’ intended use of their IVD products. The FDA can expect an earful from groups representing diagnostic makers and ...
The US Food and Drug Administration (FDA) has finalized a draft guidance on the distribution of investigational in vitro diagnostic (IVD) products, establishing the conditions under which the agency ...
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