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Chart 1_FDA Device Pathways.jpg
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.jpg
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 3_Due Diligence Review.jpg
Chart 3
Due Diligence Review

Provides an outline of the regulatory review process.

Chart 4_510k Engagement Outline.jpg
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!