The New 510(k) Paradigm for Clinical Submission to FDA

The new 510(k) clinical submission method for medical device and diagnostic kit provides 2 optional approaches to the Traditional 510(k) method for obtaining 510(k) marketing clearance under certain instances:

• Special 510(k) clinical submission
• Abbreviated 510(k) clinical submission.

The Special 510(k) utilizes certain aspects of the QSR (Quality System Regulation) and the Abbreviated 510(k) relies on the use of guidance data, documents, quality-controlled, assured for accuracy and consistency, special controls, processes and recognized standards to facilitate the 510(k) review. The Traditional 510(k) clinical submission is the original complete submission to FDA in accordance with 21 CFR 807. FDA developed the new paradigm to "streamline" the evaluation of Premarket Notifications under special and abbreviated conditions as warranted and as regulated.

As always, fda.gov, provides a "go to" section where interested parties may find clarity - "Frequently Asked Questions" on the New 510(k) Paradigm.

Clinical Submission of a 510(k) is sent to FDA and logged in by the document Mail Center, the 510(k) is sent to the appropriate reviewing division for the type of device or diagnostic kit. Delivery to the proper review division will be facilitated by completing information on the Cover Sheet and Cover Letter, such as advisory panel Code of Federal Regulations reference and product code. Upon receipt in the proper reviewing division, the reviewer utilizes the Pre-Review Form, Company/Device or Diagnostic Kit Form, as an initial screening tool. The reviewer "will" use the Screening Checklist for Traditional, Abbreviated and/or Special Premarket Notification 510(k) Clinical Submission Form to assure that the 510 (k) is administratively complete. If the file is not complete and comprehensive - a refusal to file, RTF will issued and the file sent back to the submitter. QC the file, QC the contents, QC the Table of Contents for accuracy and completeness. Ensure a successful 510(k) clinical submission filing - utilize QC. QC to ensure that the contents provided to FDA in the Cover Sheet, Cover Letter and the contents of the 510(k) are consistent, concise and accurate.