Analytical Framework for Examining the Value of Antibacterial Products. 5.1.4 FDA 510(k) Submission Costs


Upon completion of clinical research, the manufacturer of the new diagnostic needs to prepare the labeling for the product and submit it to FDA.  We estimate this effort at $20,000 for a new rapid POC diagnostic manufacturer.  Additionally, under the Medical Device User Fee Act (MDUFA), device sponsors must pay a fee for entering the FDA review process.  The 2013 FDA fee for 510(k) submissions is $4,960.  Lower fees apply for small businesses.  The costs for preparing this regulatory submission (i.e., 510(k) clearance package) could be highly variable depending on device characteristics.  We estimate this cost at $100,000 based on ERG’s previous research (Eastern Research Group, Inc., 2012).  Combined, the costs for submitting a 510(k) application to FDA with clinical data are estimated at $124,960.

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