This class is defined as the most riskiest one out of all FDA 510k classes. These types of products and devices will require you to submit a 510k “Pre-market Notification” to get your new product or device FDA 510k clearance approved.Ĭlass III - This classification is for companies that develop, manufacture, distribute, and/or import medical products and devices that are new to any market. These types of products and devices are created to be extremely similar to other already legally marketed products. These types of medical devices and products can almost immediately be marketed upon FDA approval but must comply with any and all other guidelines set forth by the FDA.Ĭlass II - This classification is for companies that manufacture or import medical devices that are considered to be more harmful than Class I products and devices. These types of products typically do not require strict FDA 510k review process. The FDA currently breaks these classification categories down by how safe and effective the actual product or device is considering it’s purpose and use- FDA 510K ClassificationsĬlass I - This classification is for products that are not harmful and are low risk to the general population. If interested in selling your new medical device in the US, you should know that they allow four different broad pathways for individuals and companies to develop, manufacture, or distribute these products in the USA. We want you to know that we understand that we are working for you and with you on this project.įDA Approval Process Of New Medical DevicesĪny and all medical devices, medical products, medical instruments, and medical equipment that are legally bought and sold in the US are regulated by the FDA. Send that to us and we will sign it and now you know that we are protecting this information for you. Therefore, we have a simple Non-Disclosure form that you can print off, fill in your name and device name and sign. We cannot do the research and preparation without your device information. We deal with this type of information on a daily basis and we understand to protect your information. We have some clients that are reluctant to offer us any information regarding their device due to trade secret information. 510k FDA Consulting follows through the process with the FDA reviewer to complete and obtain.FDA completes a preliminary review and then submission moves into the substantive review.All 21 sections of the submission will be completed and formatted per FDA regulations by the.Client will send files of documents to 510k FDA Consulting for the preparation and writing.Number, classification and predicate device to be used for the submission. Consultant will evaluate the new medical device and determine the product code, regulation.Client will receive a Checklist of the information/data needed for the 510k submission.Assist Client with Application for Small Business Certification, if applicable.Client signs 510k FDA Consulting Contract.Determined the need for Premarket Submission 510k.Top 10 List for Getting Started with your 510k We have a proven track record of clearing medical devices it’s time for you to take advantage of our skills and the benefits of our services. Let 510k FDA Consulting pull the missing pieces together.
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