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Ronda A. Balham, O.D

Ronda A. Balham, O.D., has 19 years of Food & Drug Administration (FDA) experience including 13 years at the FDA in many capacities including several years at the Center for Devices and Radiological Health (CDRH) where she began her career as a clinical reviewer. Dr. Balham brings to Kinexum her expertise in the premarket approval and clearance processes for medical devices; the Humanitarian Device Exemption process; and regulatory due diligence for medical device products.

She also has extensive experience in the international regulation of medical devices having spent a year as a Mansfield Fellow working at the Ministry of Health, Labour and Welfare in Japan in both the medical device and orphan product divisions, two years as the Executive Secretariat for the Global Harmonization Task Force, and two years as a medical device consultant in Europe [elaborate]. Dr. Balham has made numerous presentations both nationally and internationally on the regulation of medical devices.

Professional services provided by Dr. Balham mainly include:

Medical device and diagnostic product profiling, competitive landscapes, orphan designation, combination products
US and International regulatory strategies and tactics, gap analyses, developmental risk assessments
Integrated global registration approaches
Design and preparation of meetings, advisory panels, and other important communications with U.S. FDA review divisions and policy makers and other international authorities
Design, production oversight, and/or critique of regulatory documentation: IDEs, 510(k)s, PMAs and annual reports
Response to regulatory emergencies such as product recalls and clinical holds
Due diligence
Regulatory climate forecasting and anticipated expectations