United States 510(k) Premarket Notification Remediation
With all our best intent in an original 510(k) application, FDA rarely clears a product without requesting additional information. At times you may wonder if FDA even read your application based on their questions, where other times they may be challenging the sufficiency of your data in support of substantial equivalence. Both of these situations require careful consideration and a well written response.
With FDA's updated practice of allowing only a single Additional Information (AI) Response before rendering their SE / NSE determination, it is increasingly important to effectively respond to FDA AI questions the first time. Responses to FDA AI questions need to be well crafted, thorough and concise, while leaving no point unaddressed.
Van Hoven Consulting has worked with numerous medical device manufacturers, of varying device types, answering 510(k) additional information requests. To date, all FDA AI responses I have written have led to subsequent 510(k) clearances.
Van Hoven Consulting has extensive experience addressing FDA questions of all types, from those relating directly to product testing and determination of acceptance criteria, to those relating to regulatory and marketing strategy. I have worked with FDA on determining bench, animal, and clinical trial requirements, as well as have successfully justified how data supports product safety and efficacy and / or substantial equivalence.
If your company is looking for help with their 510(k) remediation, contact Van Hoven Consulting today to discuss your strategy for completing your 510(k) submission and gaining FDA 510(k) clearance.
With FDA's updated practice of allowing only a single Additional Information (AI) Response before rendering their SE / NSE determination, it is increasingly important to effectively respond to FDA AI questions the first time. Responses to FDA AI questions need to be well crafted, thorough and concise, while leaving no point unaddressed.
Van Hoven Consulting has worked with numerous medical device manufacturers, of varying device types, answering 510(k) additional information requests. To date, all FDA AI responses I have written have led to subsequent 510(k) clearances.
Van Hoven Consulting has extensive experience addressing FDA questions of all types, from those relating directly to product testing and determination of acceptance criteria, to those relating to regulatory and marketing strategy. I have worked with FDA on determining bench, animal, and clinical trial requirements, as well as have successfully justified how data supports product safety and efficacy and / or substantial equivalence.
If your company is looking for help with their 510(k) remediation, contact Van Hoven Consulting today to discuss your strategy for completing your 510(k) submission and gaining FDA 510(k) clearance.