Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Devices Track
Presenter
Hina Pinto, MSE
Associate Director
Regulatory Policy and Combination Products
Office of Product Evaluation and Quality (OPEQ)
Center for Devices and Radiological Health (CDRH)
U.S. Food and Drug Administration (FDA)
Hina M. Pinto is the Associate Director for Regulatory Policy and Combination Products in CDRH’s Office of Product Evaluation and Quality (OPEQ). In this role, Hina collaborates across the Agency on cross-cutting regulatory and policy matters, many of which apply to the review and regulation of combination products. Hina also oversees complex regulatory projects, provides leadership and regulatory support on the development and implementation of regulations and guidances, and serves as a focal point for product classification and jurisdiction questions.
Hina joined CDRH in 2001 as a lead and engineering reviewer of various life-supporting and life-sustaining anesthesiology, respiratory, and interventional cardiology medical devices. Hina has also served as Team Lead and Regulatory Advisor in the Regulation, Policy, and Guidance (RPG) team, where she was involved in a range of regulatory and scientific issues in OPEQ, including development and implementation of product-specific and cross-cutting policies for device regulation. Prior to her current role, Hina served as Deputy Division Director within the Office of Clinical Evidence and Analysis, where she provided leadership support and oversight to policy and operations teams, which are responsible for the IDE, Breakthrough Devices, Safer Technologies, and Expanded Access Programs, as well as the Postmarket Mandated Studies and RWE Programs. Hina received her B.S. in Applied Science from the University of North Carolina-Chapel Hill and M.S.E. in Biomedical Engineering from Tulane University.
Abstract
Hina Pinto’s presentation clarifies the regulation of combination products, defined as those combining two or more types of medical products (drug, device, or biologic), whether combined into a single entity, co-packaged, or cross-labeled. Determining the appropriate lead center for review (CDER, CBER, or CDRH) depends primarily on the primary mode of action (PMOA), or an algorithm if PMOA is unclear, considering factors like experience with similar safety questions or expertise. Product Jurisdiction Officers (PJOs) in each center and the Office of Combination Products (OCP) are crucial resources for navigating classification, assignment, and regulatory questions. While no specific submission type exists for combination products, the lead center’s standard pathways, such as 510(k), De Novo, or PMA in CDRH, are used, with review assessing the product as a whole. Best practices emphasize determining jurisdiction and engaging early with the FDA, potentially via the pre-submission program, to discuss the product and regulatory strategy. Recent updates include guidances on pre-market pathways and human factors, and a proposed rule for wound dressings that suggests a split classification based on antimicrobial content. While no dedicated database exists, information on cleared or approved combination products can be found using searchable fields in the 510(k) and PMA databases.