shimonv
Trusted Information Resource
Hi folks,
FDA Guidance for the Content of Premarket Submissions does not clearly specifies where to include the Human Factors report.
I have seen applications where the Human Factors report was part of "Performance testing- Bench" which is not correct, and I have seen applications where Human Factors report had its own section - "Performance testing- Human Factors".
What is your experience?
Thanks,
Shimon
FDA Guidance for the Content of Premarket Submissions does not clearly specifies where to include the Human Factors report.
I have seen applications where the Human Factors report was part of "Performance testing- Bench" which is not correct, and I have seen applications where Human Factors report had its own section - "Performance testing- Human Factors".
What is your experience?
Thanks,
Shimon