Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Devices Track
Presenter
Katelyn Bittleman, PhD
Policy Analyst
Compliance and Quality Staff
Office of Product Evaluation and Quality (OPEQ)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Katelyn Bittleman is Policy Analyst in the Compliance and Quality Staff in CDRH’s Office of Product Evaluation and Quality (OPEQ). She is responsible for developing and managing initiatives to strengthen OPEQ’s compliance skill sets and promote the importance of quality in medical devices. Katelyn joined FDA/CDRH in 2015 as a compliance reviewer and has extensive experience in post-market compliance, cross-cutting policy initiatives, and collaborating with external stakeholders.
Katelyn earned a BS degree in Bioengineering at SUNY Binghamton before attending the Virginia Tech-Wake Forest University School of Biomedical Engineering and Sciences to obtain a PhD in Biomedical Engineering.
Abstract
Katelyn Bittleman presents on the FDA’s final guidance clarifying the distinction between medical device remanufacturing and servicing. The guidance defines remanufacturing as a significant change to a device’s performance, safety specifications, or intended use, which differs from servicing. A key tool provided is a flowchart to help assess physical changes, considering factors like body contact, component specifications, and new risks. Software changes are evaluated separately. If an activity constitutes remanufacturing, the entity becomes subject to full manufacturer regulatory requirements, including quality system regulations (QSR/QMSR), registration, listing, and marketing authorization. Guiding principles emphasize a risk-based approach, considering individual and cumulative changes, and adequate documentation. The presentation also discusses recommended OEM labeling content for reusable devices to facilitate proper servicing, notes that refurbishment generally falls under servicing, and explains why servicers are not currently required to register or list with the FDA.