Revision: FDA Guidance for Remote Evaluations
Recommendation
11/12 February 2025
Heidelberg, Germany
Medicinal Products/Drugs meet Medical Devices
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In April 2021, the US Food and Drug Administration (FDA) published a Guidance for Industry on remote evaluations. Anyone hoping at the time that the FDA would carry out these remote evaluations with the same or comparable status to an on-site inspection was mistaken. Even the title "Remote Interactive Evaluations" avoided the word inspection or audit. So, now the successor has been published as a draft. But not much has changed.
The only notable addition is that organisations must give their prior written consent for the remote interactive evaluation to be carried out. Measures that will be taken if this consent is not given are not mentioned.
And this time, comments on the draft are possible. In April 2021, it was merely pointed out that the document would be implemented immediately, without public participation in the development of the final guidelines.
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