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.