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Every 510K medical device submission is unique. Accordingly, prices will vary based on product, complexity of submission, completeness of required elements, and time estimated for assessment completion. If a manufacturing site visit is requested, or required, additional per diem, travel and lodging fees will apply. Please contact us via e-mail (510K Assessment Quote) in order to receive an estimate of cost.
Please Note: We are independent medical device consultants, not a Third Party Reviewer, per the FDA. Formal Premarket Notification 510(k) submissions for medical devices are submitted by your company, after our review, input & recommendations, and will be reviewed and processed by the Center for Devices and Radiological Health (CDRH) within the Food and Drug Administration (FDA). The Office of Device Evaluation (ODE) and the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) within CDRH are responsible for the processing and review of 510(k)s for marketing clearance in the U.S. Branches within these offices are organized according to medical scientific disciplines. ODE and OIVD staff includes biomedical engineers, physicians, microbiologists, chemists, etc., that performs scientific reviews of 510(k)s and other research (Investigational Device Exemption) and marketing applications (Premarket Approval). These individuals are commonly referred to as reviewers. It is their recommendation that determines whether a new device is substantially equivalent (SE) or not substantially equivalent (NSE).
Please note that the submitter should consider the Quality Systems (QS) regulation before and during the 510(k) process. Class II, Class III, and certain Class I devices are subject to design control requirements of the quality system regulation during the design phase of product development. For more information on the QS regulation, please refer to Quality Systems.
While we do not submit your 510K paperwork for you, we will assist in the preparation and review of the necessary material needed to accomplish that purpose.
More to follow….
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