Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Devices Track
Presenter
Indira Rao Konduri, MS
Deputy Director
FDA UDI Implementation Lead
Division of Regulatory Programs 3 (DRP3)
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)
Indira Rao Konduri serves as the Deputy Director for the Division of Regulatory Programs 3 (DRP3) in the Office of Regulatory Programs (ORP), Office of Product Evaluation and Quality (OPEQ) in CDRH. Indira is responsible for leading the UDI program, and oversees Medical Device Adverse Events, Recalls, Device Allegation programs.
Indira joined the FDA in 2000 as an IT Specialist. She later became Chief of the Information Analysis Branch, where she initiated and led the successful launch of the electronic Medical Device Reporting (eMDR) Program. From 2010-2011, Indira worked at Health Resources and Services Administration (HRSA) as Chief of the Compliance Branch in the Division of Practitioner Data Banks (DPDB). In 2011, Indira returned to CDRH to work on the Unique Device Identification (UDI) Program and served as the Program Manager for the Global Unique Device Identification Database (GUDID) until 2019, when she left to work for FDA’s Office of Regulatory Affairs. At ORA, she worked as the Business Process Manager for the FDA ACE/IWS system, which receives, and processes FDA regulated imported products. Prior to her work with the FDA, Indira’s work experience includes working as a Software Engineer at Verizon; Medical Technologist at two community hospital laboratories. Indira earned a B.S. in Clinical Laboratory Science from the University of Nevada, Reno in 1994 and an M.S. in Information Systems and Accounting from Virginia Polytechnic Institute and State University in 1998.
Abstract
Indira Rao Konduri’s presentation focuses on the Unique Device Identifier (UDI) program, established to standardize medical device identification throughout distribution and use. The UDI rule requires devices and their packages to carry a UDI and labelers to submit identification data to the Global Unique Device Identification Database (GUDID). The UDI comprises a Device Identifier (UDIDI), unique to a device version/model and labeler, and a Production Identifier (UDIPI), detailing manufacturing specifics like lot or serial number. All compliance dates have largely passed, and the focus is now on ensuring correct compliance and promoting adoption and implementation across the healthcare ecosystem. FDA actively uses UDI data from GUDID, adverse event reports (MDRs), and recalls to enhance device analysis, performance tracking across versions, and regulatory decision-making, significantly contributing to patient safety transformation. Maintaining accurate and complete data in GUDID, including updates like commercial distribution end dates and Global Medical Device Nomenclature (GMDN) codes, is crucial for both regulatory compliance and industry benefit. FDA is also advocating for UDI inclusion in areas like CMS claims data to further drive its utility at the point of care.