510(k) Submission Process
- Log-in Procedures
- Division Acceptance and Review
- Reviewer Assignment
- FDA Requests for Additional Information
- Decision Letter Issued
- 510(k) Status Program
Premarket Notification 510(k) submissions 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) and the Office of In Vitro Diagnostics and Radiological Health (OIR) 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 OIR 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.
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.
Please Note: If the person who intends to market the device uses a consultant or another party to prepare the 510(k), the 510(k) submission should specify who the 510(k) owner is and who the preparer is. The 510(k) owner is the individual or firm that has legal authority to the device.
The DMC database program will first check the system to ensure user fees have been received. Please note, payment of user fees should correspond with the date of receipt of the submission. FDA will consider the 510(k) submission incomplete and will not accept it for filing until the fee is paid in full. The DMC will also check for a valid eCopy of the 510(k) submission after processing the user fee payment. If the eCopy is not valid, then the submission will be placed on eCopy hold. The date of receipt is the date that the submission has been received with a valid eCopy AND the fee has been paid in full.
Next, 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 a 510(k) in the order that it will be reviewed. 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 510(k) contact person identified in the 510(k) submission. The acknowledgment letter is not a marketing clearance letter (SE letter). It is only an acknowledgment of receipt of the 510(k) by FDA. The acknowledgment letter provides the 510(k) number which must be referenced for all communication with FDA regarding the 510(k). If the 510(k) acknowledgement letter is not received after 2 weeks contact the Division of Small manufacturers Assistance (DSMICA) for assistance.
- View the 510(k) Process Video (Windows Media Video)
After the 510(k) is logged in by the Document Mail Center, the 510(k) is sent to the appropriate ODE or OIR reviewing division for the type of device. Delivery to the proper reviewing 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.
- Division of Surgical, Orthopedic, and Restorative Devices
- Division of Cardiovascular Devices
- Division of Ophthalmic, Neurological and ENT Devices
- Division of Reproductive, Abdominal, and Radiological Devices
- Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices
- Division of Chemistry and Toxicology Devices
- Division of Immunology and Hematology Devices
- Division of Microbiology Devices
Upon receipt in the Division, the reviewer utilizes the Pre-Review Form: Company/Device History form as an initial screening tool. The reviewer may use the Screening Checklist for Traditional/Abbreviated Premarket Notification (510(k)) Submissions form to assure that the 510(k) is administratively complete. (A checklist for Special 510(k) is being developed.) The scientific review on the 510(k) submission will proceed if it is administratively complete. The submitter will not receive an acceptance letter when a file is determined to be administratively complete.
If the 510(k) is administratively incomplete, a recommendation to issue a "Refuse to Accept" letter will be forwarded to the division supervisor for concurrence. If the recommendation not to accept has concurrence, a Refuse to Accept letter, detailing the omissions and inadequacies, will be mailed to the submitter within approximately 30 days of receipt of the original submission. The letter will specify what information must be submitted if the submitter wishes to pursue clearance for marketing. The 510(k) will be placed on hold until the additional information is received.
If the submitter receives a Refuse to Accept letter, the required information or a letter requesting an extension of time to obtain the information should be sent to the Document Mail Center within 30 days. An extension request may be submitted for up to 180 days from the date of the Refuse to Accept letter. (See FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment) This review counts as one review cycle. If neither is received within 30 days, the 510(k) may be deleted from the system. If the 510(k) is deleted from the system, a new complete 510(k) would have to be submitted to pursue FDA marketing clearance.
The reviewer will utilize the review template (instructions) as well as the 510(k) "Substantial Equivalence" Decision-Making Process Flowchart to assure that the 510(k) meets regulatory requirements. Once the final decision is determined, the reviewer fills out the Cover Sheet Memoradum. The reviewer adds the Center Tracking System (CTS) decision code, such as substantially equivalent (SE) or not substantially equivalent (NSE) code. The Cover Sheet Memorandum, along with the 510(k) Review Memorandum, is then forwarded, as part of the 510(k) submission, to the branch chief and division director for concurrence and signature.
The 510(k)s are reviewed, in order, according to the original or additional information receipt date assigned by the Document Mail Center. Most reviewers are assigned 510(k)s, IDEs and PMAs for review at the same time. Some 510(k)s are awaiting review, some may be on hold waiting for additional information, and some are under active review. A 510(k) may require a consulting review by another CDRH office or another FDA Center. 510(k)s and PMAs that are granted expedited review are taken out of turn and reviewed first.
When the reviewer needs additional information to complete the review, he or she will either telephone the submitter with a simple request or prepare a deficiency letter which will detail the additional information needed. In the latter case, while the reviewer is waiting for the additional information, the submission is placed on "hold" and is not considered to be under active review.
A response to additional information should:
- identify the submission as additional information to the 510(k),
- reference the date of FDA's request for additional information,
- include your company name and 510(k) number, and
- provide the information in an organized tabulated manner. A table of contents is recommended.
In accordance with 21 CFR 807.87(l), FDA may consider a 510(k) to be withdrawn if the submitter fails to provide additional information within 30 days of an Additional Information (AI) request. FDA generally permits submitters additional time to respond to such requests. FDA intends to automatically grant a maximum of 180 calendar days from the date of the AI request, even if the submitter has not requested an extension. Therefore, submitters are no longer required to submit written requests for extension. FDA intends to issue a notice of withdrawal under 21 CFR 807.87(l) if FDA does not receive, in a submission to the appropriate Document Control Center, a complete response to all of the deficiencies in this AI request within 180 calendar days of the date of this request. If a submitter then wishes to resubmit this 510(k) notification, a new number will be assigned and the submission will be considered a new premarket notification submission.
Please Note: Any 510(k) correspondence submitted to FDA regarding your 510(k) under review, whether requested by FDA or voluntarily submitted, must be submitted to the Document Mail Center. Under certain conditions faxed copies may be accepted to the official 510(k) file. The correspondence should include the company name and the 510(k) document control number. Do not direct correspondence to the reviewer. Information submitted to a reviewer or without the 510(k) document control number may be misrouted or improperly logged into the 510(k) tracking system.
The decision letter will be mailed and faxed, if a fax number has been provided, to the submitter upon receipt of the completed 510(k) from the reviewing division. The Document Mail Center staff will enter the final decision into the database and prepare the complete 510(k) file for electronic imaging. After completion of electronic imaging, and back-up microfilming, the original 510(k) files are destroyed.
Submitters may request information on their 510(k) review status 90 days after the initial log-in date of the 510(k). Thereafter, the submitter may request status reports every 30 days following the initial status request. To obtain a 510(k) status report, the submitter should complete the status request form, FDA 3541, and fax it to the CDRH office identified on the form. Within three working days after a status request is received, CDRH will send the submitter a fax that includes:
- The ODE or OIR division or branch to which the 510(k) is assigned;
- The last action, and date of action, that ODE or OIR 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.
Please do not phone reviewers for the status of your 510(k) as it is counterproductive and it is not fair to other manufacturers who have not called and are patiently awaiting their turn in the review process.