Myths About FDA

Unless you have a formal meeting request, the FDA human factors team cannot talk to you.

False.  The FDA Human Factors team wants to hear your questions about human factors. Human Factors is a relatively new requirement in pre-market approval. It is advantageous for you to discuss your questions before running a user study or writing a report.  Don’t guess!  Visit the FDA Human Factors website for details on how to contact the team.

If you have a formal pre-market submission in progress, you may need to contact your lead reviewer to arrange a meeting with the human factors team, but for more general questions, you can contact the team directly.

Any of the FDA’s Human Factors Draft guidances are not in effect until they are finalized and officially released.

False.  A draft guidance represents the current thinking of reviewers regarding work that is needed in a submission and how to format and report your work.  The guidance is labeled “draft” because there is a period when industry feedback must be formally collected.

Human Factors is a new FDA requirement for pre-market approval.

Partially true.  Human Factors has always been implied in the management and control of use risks and the Quality System Regulations, because use error is considered a non-conformity that should have been addressed in design. More consistent human factors reviews started in 2008 at CDRH, and have been added to combination product pre-market reviews since 2010