FDA 510K CONSULTANTS, LLC
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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.
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.
Due Diligence Review
Provides an outline of the regulatory review process.
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!