Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Devices Track
Presenter
LCDR Sara Onyango, DHSc, MPH, MSN
United States Public Health Service Commissioned Corps
Medical Device Specialist
Investigator
Medical Device and Radiological Health Operations/Division I
Office of Regulatory Affairs (ORA)
U.S. Food and Drug Administration (FDA)
LCDR Sara Onyango is a Medical Device Investigator with the U.S. Food and Drug Administration and is stationed at the New England District Office in Winchester, MA. She’s been on active duty in the U.S. Public Health Service Commissioned Corps for the past twelve years, with deployments to a federal prison and long-term care facility to assist with the COVID-19 pandemic, Liberia to assist with an Ebola outbreak, and Puerto Rico to provide medical care following hurricane Maria. She became a Women’s Health Nurse Practitioner in 2021 and volunteers as a clinician at two community clinics serving uninsured women. She received her Doctorate in Health Science from Nova Southeastern University, her Master of Science in Nursing from Frontier Nursing University, her Master of Public Health from the University at Albany, her Bachelor of Science in Nursing from Villanova University, and her Bachelor of Science in International Health Science from SUNY Cortland. She is a Certified Health Education Specialist (CHES) and a former high school health science teacher. She and her husband are currently working to open a women’s preventive health clinic in rural Kenya.
Abstract
Sara Onyango’s presentation details the FDA medical device inspection process, focusing on the closing meeting where Form FDA 483, Inspectional Observations, may be issued to document deviations from regulations. While the 483 notes investigator observations, it is not a final compliance determination. Firms can annotate the 483 at the meeting or provide a written response afterwards, which is encouraged and can influence the final inspection classification. The agency internally classifies inspections as No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI), with OAI suggesting significant issues potentially leading to further action like a warning letter or regulatory action. The Establishment Inspection Report (EIR) is provided after the inspection is finalized, typically within 45 days of that determination. The most common 483 citations for medical device firms are related to CAPA and complaint handling. A key pitfall discussed is inadequate CAPA effectiveness checks, which must include a plan, timeframe, sample selection rationale, acceptance criteria, and objective evidence to demonstrate the corrective action’s effectiveness. While incomplete reports are accepted, reporters must document efforts to get missing information and submit supplemental reports when new details become available. Devices legally marketed in the US with adverse events occurring overseas are reportable. FDA encourages robust reporting to build data for monitoring device performance and enhancing patient safety, making aggregated data available in the Maude database.