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

04/15/2014

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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