Device Advice All CDRH
510(k) Submission Process Introduction
Division Acceptance Criteria
FDA Requests for Additional Information
Decision Letter Issued
510(k) Status Program
Freedom of Information Requests for 510(k) Information
Much of the information on this page has been taken from Chapter 3 of the 510(k) manual for general medical devices. However, this page goes into more detail, and includes updates. Premarket notification submissions [510(k)]s for medical devices are 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) within CDRH is responsible for the processing and review of 510(k)s and providing a decision related to clearance to market medical devices in the U.S. Within ODE there are six divisions organized according to medical scientific disciplines. Each ODE division has a scientific staff that includes biomedical engineers, physicians, microbiologists etc., that performs scientific reviews of 510(k)s and other research (IDE) and marketing applications (PMA).
These individuals are commonly referred to as ODE reviewers. For the most part, it is their recommendation that determines whether a new device is substantially equivalent (SE) or not substantially equivalent (NSE). The following is a description of how 510(k)s are processed and reviewed by ODE and the 510(k) programs that affect this process. Log-in Procedures Upon receipt in the CDRH Document Mail Center (DMC) located within ODE, 510(k) submissions are date stamped and logged into the DMC computer database where a unique control number is assigned to the document. This number is referred to as the "document control number", "510(k) number", or just "K number". The document control number begins with the letter "K" followed by 6 digits. The first two digits designate the calendar year the application was received; the last four digits represent the submission number for the year. The address of the DMC is included in the Premarket Notification [510(k)] manual, where to submit your 510(k).
The DMC database program will assign the 510(k) a due date and sequential position in the queue based on the receipt stamp date. The queue is a system of positioning 510(k)s in the order they are being reviewed or will be reviewed by the ODE reviewer. The lower the number in queue the closer a 510(k) is to a completed review. The database program will generate an "acknowledgment letter" with the assigned 510(k) number. The acknowledgment letter will be mailed to the submitter or applicant if different from the submitter. The acknowledgment letter is not a SE letter providing marketing clearance. It is simply an acknowledgment of receipt of your 510(k) by FDA. It is important to maintain the acknowledgment letter containing your "K number" because the "K number" is necessary for all communication with FDA regarding your 510(k). If the 510(k) acknowledgement letter is not received after 2 weeks contact the Division of Small manufacturers Assistance (DSMICA) for assistance.
Division Acceptance Criteria After the 510(k) is logged in by the DMC, one copy is maintained there and the other is sent to the division appropriate for the classification of the device within ODE. The five ODE divisions are as follows: Division of General, Restorative and Neurological Devices Division of Dental, Infection Control, and General Hospital Devices Division of Clinical Laboratory Devices Division of Cardiovascular and Respiratory Devices Division of Ophthalmic and Ear, Nose, and Throat Devices Division of Reproductive, Abdominal, and Radiological Devices Including accurate classification information on the Cover Sheet or Cover Letter, such as, panel, Code of Federal Regulations reference, and product code will facilitate delivery to the proper reviewing division. A designated person within the division will review the submission against the "Refuse to Accept" checklist.
A recommendation to accept the 510(k) or issue a "Refuse to Accept" letter will be forwarded to the division supervisor for concurrence. A copy of the Refuse to Accept policy and checklist is included in Appendix B of the 510(k) Manual. The Refuse to Accept checklist used by the divisions contains the same information included on the Premarket Submission Cover Sheet Elements List discussed in the Content of a 510(k) page. Therefore use of the Elements List and assuring data on this list is included in your 510(k) will greatly increase the probability of your 510(k) being accepted by ODE for review. If the recommendation to accept has concurrence, the 510(k) will be assigned to a division reviewer. In this case, you will not receive an acceptance letter. If the recommendation not to accept has concurrence, a Refuse to Accept letter, detailing the omissions and inadequacies, will be mailed to the submitter or applicant within approximately 30 days of receipt of the original application. The letter will specify what information must be submitted if the applicant wishes to pursue clearance for marketing. If you receive a Refuse to Accept letter, send FDA the required information or a letter requesting an extension of time to obtain the information requested to the DMC within 30 days. If neither is received within 30 days, the 510(k) may be deleted from the system. In this case another 510(k) will be required for you to pursue FDA marketing clearance. Reviewer Assignment Several things can affect how quickly 510(k)s are reviewed, such as: IDEs and PMAs have statutory due dates and therefore take priority over 510(k)s; 510(k)s and PMAs granted expedited review are taken out of turn and reviewed first; If additional data is requested from FDA by letter, the application is put on hold; and Consulting review of 510(k)s by another CDRH office or another FDA Center.
FDA Requests for Additional Information When the reviewer needs additional information to complete the review he or she will either telephone the applicant with a simple request or prepare a deficiency letter which will detail what additional information is needed. In the latter case, while the reviewer is waiting for the additional information, the application is placed on "hold" and thus is not considered to be under active review. These written requests for additional information usually request a response within 30 days. If additional time is needed to gather the requested information, the 510(k) submitter may request an extension within the 30 days of FDA’s request for information.
Any information to be added to the 510(k) file must be submitted in writing to the DMC, clearly identified as additional information or a request for an extension of time, and must include the "K" number. The 510(k) may be deleted from the DMC database if there is no response to the request for additional information within 30 days of FDA’s request letter. Please Note: Any information submitted to FDA to be added to the 510(k) submission whether required by FDA or voluntarily submitted must include the "K" number. Information submitted without the "K" number may be misrouted or improperly logged in. Administrative Review After the scientific review is completed, the reviewer’s recommendation is forwarded to the division director for concurrence.
Before an SE letter can be issued for a class III device, ODE will contact the CDRH Office of Compliance (OC) to verify the current Good Manufacturing Practices (GMP) status of the 510(k) submitter. The purpose of this process is to prevent issuing marketing clearances to 510(k) submitters with significant GMP violations, reasonably related to the device, that could result in the production of unsafe and/or ineffective devices until such time as the device related violations are corrected. When a 510(k) is received for a Class III device in the DMC, the OC is notified. The 510(k) takes its normal route through the ODE while the OC contacts the 510(k) submitter and the FDA District Office to confirm the current GMP status of the manufacturer.If the manufacturer has been inspected within the last two years and no GMP violations had been noted, this information is relayed to ODE and the 510(k) review is not impeded.
If there is no current inspectional information available for the manufacturer, the OC will issue an inspection of the firm. If the inspection reveals no GMP violations, the ODE is notified and the 510(k) review continues. If the previous or current inspection reveals a GMP problem, reasonably related to the device, a determination of SE cannot issue until such time that the device related violations are resolved with the district office and the OC. Decision Letter Issued
The ODE will issue the decision letter to the submitter upon receipt of the completed 510(k) documentation from the reviewing division and clearance from the Office of Compliance. The DMC staff will enter the final decision into the database and prepare the complete 510(k) file for electronic imaging into the computer. After completion of electronic imaging, and back-up microfilming, the original 510(k) files are destroyed. 510(k) Status Program Applicants may request information on their 510(k) review status 90 days after the initial log-in date of the 510(k).
Thereafter, the applicant may request status reports every 30 days following the initial status request. To obtain a 510(k) status report, the applicant should complete the status request form (also included in Appendix H of the 510(k) Manual) and fax or mail it to the CDRH office identified on the form. Within 3 working days after a status request is received, CDRH will send the applicant a fax or letter that includes: The ODE division or branch to which the 510(k) is assigned; The last action, and date of action, that ODE has taken regarding the 510(k); The position of the 510(k) in the reviewer’s queue; and The average review time for the division or branch.
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