Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Devices Track
Presenter
Kathryn J. De Laurentis, PhD
Policy Analyst
Pre-Market Notification Team (PMNT)
Office of Regulatory Programs (ORP)
Office of Product Evaluation and Quality (OPEQ)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Kathryn J. De Laurentis has been a Policy Analyst since 2020 on the 510(k), De Novo, 513(g), Device Determinations and Custom Devices Lifecycle Team. She contributes to several pre-market programs and currently is the primary 510(k) team lead for eSTAR submissions, the CDRH Portal, and Least Burdensome flags.
Kathryn began her tenure at the FDA in 2014 as a Biomedical Engineer/Scientific Medical Device Lead Reviewer in the Division of Neuromodulation and Rehabilitation Devices, Office of Neurological and Physical Medicine Devices (OHT5). She evaluated numerous physical medicine devices, such as, exoskeletons, prosthetic devices, and wheeled mobility devices, through a variety of submission types (that is, Premarket Approvals, Premarket Notifications (510(k)), Q-Submission Requests, and 513(g) Requests for Designation). Dr. De Laurentis continues to be an instructor for internal educational programs including the Reviewer Certification Program and OPEQ-wide training for new initiatives, as well as participating in external outreach education regarding medical device premarket activities.
Prior to joining the FDA, she designed and developed assistive and medical technologies as a research professor, project/program manager, and small business owner. Her major areas of interests are the advanced design and development of robotic, mechatronic, and mechanical technologies; the development of layered/additive manufacturing technologies and techniques; the creation of smart material actuation schemes and actuated devices; and human factors.
Dr. Kathryn De Laurentis has patented and widely published her work. She received honors from organizations such as the National Science Foundation, was named a Pinellas County Emerging Entrepreneur, and is a member of the National Academy of Inventors. She earned a PhD in Mechanical and Aerospace Engineering from Rutgers, the State University of New Jersey, and has a background as a behavioral and mental health professional.
Abstract
Kathryn J. De Laurentis presents updates and procedures for the 510(k) program, the most common pathway for medical devices requiring demonstration of substantial equivalence (SE) to a legally marketed predicate device. A key update is that the eSTAR electronic submission template is now mandatory for all 510(k) submissions, along with submission via the CDRH Customer Collaboration Portal (CCP), both effective October 1, 2023. The review process includes a technical screening phase by day 15, conducted by the lead reviewer, followed by a substantive review phase. Submissions passing technical screening receive a TSOK code, while those with deficiencies receive a TSIC code letter without a checklist or RTA addendum. Responses to interactive or additional information requests are often handled by revising and resubmitting the eSTAR through the portal. Preparing the eSTAR requires attention to detail and consistency throughout the template, using the built-in help text and links to guidance to avoid technical screening holds. Submissions made via e-copy before the mandatory date are grandfathered, though sponsors can opt to switch to eSTAR. Resources like the 510(k) program guidance document and the eSTAR/CCP websites are available for assistance.