Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Devices Track
Presenter
Kendra Holter, MSN, RN
Consumer Safety Officer
Premarket Programs Branch
Division of Industry and Consumer Education (DICE)
Office of Communication and Education (OCE)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Kendra Holter is a Consumer Safety Officer in the Division of Industry and Consumer Education (DICE), in CDRH’s Office of Communication and Education. In this role, Ms. Holter educates stakeholders with understandable and accessible science-based regulatory information about medical devices and radiation-emitting electronic products. She also develops, maintains, and updates such information on the CDRH website for the purpose of industry education. She joined FDA in September 2022.
Prior to her FDA career, Ms. Holter served as the National Educator in the care and management of reusable medical devices for the Veterans Health Administration (VHA) as an agent for infection prevention. She served with VHA for a total of 15 years in various roles to include those at the facility level as manager, educator, business liaison for purchase and repair of medical devices, and operating room nurse. Ms. Holter received a Bachelor of Science in Marine Biology from the College of Charleston, a Bachelor of Science in Nursing from the Medical University of South Carolina, and a Master of Science in Nursing Informatics from Walden University.
Abstract
Kendra Holter, presenting at the 2024 FDA Regulatory Education for Industry Conference, outlines the foundational aspects of medical device regulation and submission pathways, emphasizing that while innovation progresses, the regulatory principles remain constant. She defines a medical device based on its regulatory definition, highlighting its intended use and clarifying it does not achieve its primary purpose through chemical action or metabolism. Determining if your product is a medical device is the crucial first step, with resources like Device Advice and CDRH Learn available. Devices are then classified by risk as Class 1 (lowest), Class 2 (moderate), or Class 3 (highest), which dictates the applicable regulatory controls: general controls for all devices, special controls for Class 2, and PMA controls for Class 3. Based on classification and controls, the appropriate pre-market submission type is identified, including 510(k) exemption, 510(k), Pre-market Approval (PMA), De Novo, and Humanitarian Device Exemption (HDE). Preparing submissions increasingly uses the eSTAR interactive template, required for all 510(k)s as of October 1, 2023. Submissions are sent via the CDRH Customer Collaboration Portal (CCP), mandatory for all 510(k)s as of October 1, 2023. After gaining clearance or approval, devices must still comply with general controls. Assistance is available from the DICE team, the device determination mailbox, and the 513G process. Holter advises innovators to start by confirming their product is a medical device before proceeding to classification, controls, and the submission process.