510(k) Submissions
510(k) Submission Methods
Overview
An applicant may choose from three types of Premarket Notification 510(k) submissions for marketing clearance: Traditional, Special, and Abbreviated.
Traditional method is the original complete submission as provided in 21 CFR 807. In 1998, FDA developed “The New 510(k) Paradigm” to streamline the evaluation of Premarket Notifications. The New 510(k) Paradigm provides two optional approaches to the Traditional 510(k) method for obtaining 510(k) marketing clearance under certain instances: Special 510(k) and Abbreviated 510(k). The Special 510(k): Device Modification utilizes certain aspects of the Quality System Regulation and the Abbreviated 510(k) relies on the use of guidance documents, special controls, and recognized standards to facilitate 510(k) review.
The use of either alternative does not affect FDA’s ability to obtain any information authorized by the statute or regulations. Additional guidance on the new 510(k) paradigm can be found in Frequently Asked Questions on the New 510(k) Paradigm.
The following reference flowchart below outlines which type of 510(k) is suitable for a given set of circumstances.
The 510(k) Review Fee is the same for Traditional, Special, and Abbreviated 510(k)s.
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