Overview: US FDAs submission categories and evaluation process
In this webinar, the presenters help attendees better understand the decision points they might face when determining a submission category and examine the examples provided by the FDA. The presenters also discuss the evaluation information the FDA suggests providing for each category and share practical information intended to equip manufacturers for future medical device marketing submissions.
Webinar date
Jan. 12, 2023
Speakers
Merrick Kossack, research director, Human Factors Research & Design, Emergo by UL
Allison Strochlic, research director, Human Factors Research & Design, Emergo by UL
US FDA guidelines for human factors and medical device marketing submissions
The U.S. Food and Drug Administration (FDA) issued a new draft guidance document, “Content of Human Factors Information in Medical Device Marketing Submissions,” on Dec. 9, 2022. The guidance is intended to help medical device manufacturers determine what evaluation information should be included in a marketing submission, e.g., 510(k)s, De Novo requests, PMAs, including PMA supplements, and humanitarian device exemption (HDE) applications. The guidance outlines three distinct submission categories, dependent on various factors, such as changes made to an existing device, the extent of those changes (if applicable), and the presence of critical tasks.
About the presenters
Merrick Kossack, research director, Human Factors Research & Design, Emergo by UL
For over 25 years, Kossack has helped companies develop processes and strategies to address their human factors engineering needs, particularly for complex and high-risk systems. His areas of expertise include integrating human factors engineering into established design and development processes, conducting complex usability studies, and advising on human factors strategy to satisfy regulatory needs. He received an M.S. degree in Human-Machine Systems Research from the Georgia Institute of Technology and a B.S. degree in Industrial Engineering from the University of Illinois. Kossack is a contributing author to “Applied Human Factors in Medical Device Design” (2019) and has delivered numerous presentations on the subject. He is an active member of the Association for the Advancement of Medical Instrumentation (AAMI) Human Factors Engineering subcommittee as well as IEC TC 62/SC 62A/JWG 4, both responsible for the creation of human-factors-related standards and guidance. He is also a member of the AAMI faculty staff teaching their “Human Factors for Medical Devices” course. In 2020, Kossack was inducted into UL Solutions' William Henry Merrill Society as a Distinguished Member of Technical Staff.
Allison Strochlic, research director, Human Factors Research & Design, Emergo by UL
Strochlic was one of the Emergo by UL, Human Factors Research & Design team’s co-founders, in 2005. She has spent her entire career applying human factors engineering principles to medical and pharmaceutical product development. She advises clients on how to apply human factors engineering (HFE) in a manner that meets FDA’s and other regulators’ expectations, including developing program plans and leading key meetings on various HFE topics with regulators. Strochlic contributes to and oversees a wide range of research and evaluation activities and helps manage the team’s quality management system. Strochlic is a co-author of a book titled “Usability Testing of Medical Devices,” an author of several technical articles, and an editor for the “Human Factors in Healthcare” journal. She frequently delivers conference presentations, leads panels and presents webinars on various HFE topics. Strochlic is a Certified Human Factors Professional and holds undergraduate and graduate degrees in human factors from Tufts University and Bentley University, respectively.
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