Abstract
The session will introduce you to FDA’s process, priorities, and rationale for reviewing human factors content in pre-market submissions for new medical devices. Critical components of the review process will be highlighted: 1) the types of information FDA needs to see in a successful device submission in order to ensure prompt reviews, and 2) the types of data that provide sufficient evidence of reasonably safe and effective device use for the intended users, uses, and use environments. The presenters will also discuss FDA guidance documents, including the new and updated human factors guidance document and the human factors content contained in the new infusion pump guidance, as well as relevant national and international standards that can assist manufacturers in performing effective human factors design, evaluation and testing to ensure devices are optimally safe and effective during their use, and will also in assist in preparing the human factors component of new device submissions. The speakers will discuss human factors within the assurance case model, human factors issues related to non-average populations (including lay users and people with disabilities), and issues related to review of combination products, specifically pen- and auto-injectors. The session will be interactive, with the final portion reserved for audience questions and discussion.
Get full access to this article
View all access options for this article.