NEMA comments on FDA Draft Part 11 Guidance

The Diagnostic Imaging and Therapy Systems Division of the National Electrical Manufacturers Association submitted comments on the Draft Part 11 Guidance.

Key points in the comments include:
– a request to include specific guidance on validation of hybrid systems
– a statement that the guidance is inconsistent with FDA’s own General Principles of Software Validation Guidance for example in the area of validation of off-the-shelf software.
– objection to FDA’s inclusion of draft documents as within the scope of Part 11 and a request to resolve scope issues.
– a request for FDA to allow electronic records to be exempt from Part 11 while they are in draft from.

A link to the full memorandum is provided.

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