Designing Instructional Materials to Support Health Literacy for FDA Submissions
Regulatory authorities increasingly require that users with low health literacy be included in the human factors testing of devices or drug delivery products. Users with low health literacy differ from others in the way that they interact with and interpret written materials such as instructions for use (IFU) or other printed materials that accompany medical devices or combination products.
Instructional materials designed without this important user group in mind can lead to unanticipated pre- or post-market issues that may be safety related or can derail a regulatory submission. Some research indicates that more than 50% of post-market adverse events are related to user cognitive issues. During product development, manufacturers have a prime opportunity to design materials for low health literacy users by combining best practices in instructional design and human factors testing.
Poorly written materials that do not adequately inform all users on the correct use and possible risks of devices can also lay manufacturers open to products liability suits if something goes wrong. “Failure to inform” is a common grounds for legal action against companies.
In this webinar, you will learn how to address the needs of users with low health literacy to improve product use and mitigate potential pre- and post-market issues. You will also learn how to include users with low health literacy in your human factors testing to optimize instructional materials.
What you will learn:
Who should attend:
· RA/QA professionals
· Product developers
· Instructional designers
· Human factors professionals
· Legal counsel
FREQUENTLY ASKED QUESTIONS
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Medical Technology Organization:
If you register a group of more than 2 registrations at the same time, each registration after the 1st receives a 50% discount. Remember, in order to receive this discount, registrations MUST BE MADE AT THE SAME TIME. There will be no retroactive refunds of registration fees.
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Cancellation and Refund Policy: