FDA 510k Consultants, LLC
+1 386-243-4332
Free Downloads
Chart 1
FDA Device Pathways
Illustrates how medical devices are reviewed by FDA--Registration (low risk), 510k or DeNovo (medium risk), and Premarket Approval (high risk). Applicants file a 513g Request for Classification if unsure of the medical product's regulatory classification. They file a Pre-Submission Request For Feedback ("Pre-Sub") to clarify uncertainty with intended use, comparison device (510k "predicate"), safety & efficacy testing, or other requirements.
Chart 2
FDA Device Premarket Costs
Explains typical costs for each step of the clearance process. Fees are paid to FDA ("user fee"), third-party testing labs, and the consultant. FDA also charges for 513g classification requests, but not for Pre-Sub clarification. A separate, annual registration fee must be paid to FDA by certain manufacturers, importers, and other companies involved in the import and distribution of medical devices in the United States.
Chart 4
510k Engagement Outline
Charts the many steps of the device clearance process--and thus demonstrates how much work your consultant puts into getting your product through FDA!