Using ChatGPT for regulatory submissions sounds like a potential nightmare. In the context of medical devices, the expectation is that the manufacturer evaluates suppliers, contractors and consultants "on the basis of their ability to meet specified requirements, including quality requirements" and to "define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results" (21 CFR 820.50). At the very least, proper evaluation of a LLM like ChatGPT would likely prove difficult simply due to the nature of the model and the training data used in its creation. Add to that the potential for a model to evolve beyond the initially evaluated state or for errors to be introduced due to the nature of the information being translated (not to mention potential bias in the training data) and you may end up with a struggle using such a service.
As to whether or not one may include a statement stating that the translation is done internally, that does not seem to be a completely honest statement if an externally developed LLM is used in the process.
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Christopher Erwin
Scottsdale AZ
United States
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Original Message:
Sent: 21-Apr-2023 09:36
From: Anonymous Member
Subject: ChatGPT translation of regulatory docs - FDA
This message was posted by a user wishing to remain anonymous
Hi all,
so far we have been using certified companies (ISO 17100) to translate clinical EU documents to be submitted to the FDA. Translations included investigator brochures, local competent authorities approval letters, user manuals etc. We have been quite disappointed by the extremely high cost and the poor results (since of course the translator is not a subject matter expert) and we are considering now to change strategy (and save money) and start using ChatGPT to have a first translation and have internal employees (fluent in English) to review the translation. Is this approach acceptable for FDA or there is an expectation of certified translations?
Should we include a statement saying that the translation is done internally?
Thanks for your help/