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.

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to

office@softwarecpr.com by Sep 25, 2019 if possible!

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