510(k) SUBMISSIONS

By leveraging the expertise of our seasoned consultants, you will increase your chances of obtaining FDA authorization for your product.

Fang Consulting can assist you with the FDA authorization process. Our expertise lies in medical device compliance, and our team of expert consultants has an in-depth understanding of the FDA submission process and how to avoid potential mistakes that could prolong your path to authorization. We can prepare and submit your 510(k) application more efficiently, with a reduced likelihood of receiving an initial “Refuse to Accept” (RTA) hold or an Additional Information (AI) request from the FDA reviewer. Quicker clearance from the FDA results in earlier sales for your device.

Our tried and tested method for preparing your 510(k) Premarket Notification to the FDA results in better outcomes for your device.

Fang Consulting can provide support to all stages of the 510(k) submission process, including:

Identifying a predicate
A predicate is a legally marketed medical device that shares the same intended use and technological characteristics as the device being submitted and serves as a benchmark for demonstrating substantial equivalence. Identifying the correct predicate for your device is critical to the success of your 510(k) submission.

Medical device classification review
Classification review is based on factors such as the device’s intended use, technological characteristics, and potential risks to patients. Fang Consulting can assist in classifying your device based on the level of regulatory control necessary to ensure its safety and effectiveness, which determines the type of submission required for market clearance.

Medical device product code review
A medical device product code is a unique identifier the FDA assigns based on the device’s intended use and technological characteristics. It helps classify and track devices and is required in the submission. You must identify the correct product code when submitting a 510(k) to the FDA.

Preparing a detailed gap analysis
We can help identify any discrepancies between the requirements outlined by the FDA for the submission and the actual contents of the submission. By conducting a gap analysis, manufacturers can identify potential deficiencies or gaps in the submission and take corrective actions to improve their chances of obtaining clearance for their device.

Performance data reviewal
Fang Consulting will review all performance data, including bench testing and clinical trials, and evaluate the safety and effectiveness to ensure the device meets regulatory standards and supports the claims made in the submission.
Answering post-submission questions from the FDA

The FDA may come back with questions for the manufacturer intended to clarify aspects of the 510(k) submission. In this case, Fang Consulting will handle all back and forth with the FDA and promptly provide any additional requested information.