FDA 510(k) Submission and ClearanceAs a rule, you have to file a Premarket Notification with the FDA, which is also known as an FDA 510(k) submission, if you want to sell a Class II medical device or IVD in the US. This doesn’t amount to approval of these devices for sale. It’s just the “clearance” that the “devices can be sold” in the US. However, the term, “approval” is used more for simplicity.
Here, we are providing the details of how the US FDA 510(k) medical device clearance process works. When it becomes mandatory to submit an FDA 510(k) Premarket Notification? If you are the maker of a Class II medical device (certain Class I and III devices also included) or an IVD and want to launch it in the US market, then you have to submit a 510(k) to the FDA and it’s mandatory. Also, you must submit a 510(k) in case, if the intended use of the device is going to be changed. It’s also mandatory in case the technology involved is going to be changed in a way that it may affect its effectiveness and safety aspects. How we can help with 510(k) submissions? We are a regulatory consulting and training company based in Washington DC. We have helped several pharma and medical device companies worldwide in FDA 510(k) submissions. So, if you are a device manufacturer from anywhere in the world and want to sell or launch your device in the US market, we will help you at every step of the way. From regulatory and compliance issues to the 510(k) submissions and training, we offer our services to help you succeed in the US market. Our approach involves less paperwork, little hassle and lesser chances of failure or rejection of a 510(k) submission. We make sure that the entire process is cost-effective for you. The step by step process for 510(k) submission We take proactive measures to make sure that your 510(k) submission is successful. We collect and collate all the data available for devices similar to yours that have already received 510(k) clearance from FDA. Our experts analyze device-specific guidance documents and make a detailed report on how to go for 510(k) clearance. In other words, our experts lighten your burden and reduce the cost, time and hassles for you. The Gap Analysis that we do prior to the 510(k) submission gives us and our client a good insight about how to approach the FDA for getting this clearance. We are therefore in a good shape to offer effective preparation consulting services that are result oriented. Gap analysis also helps us know the additional data required for a complete 510(k) submission. We will also arrange you a comprehensive list of documents related to your device and the corresponding information desired by the FDA and other regulatory bodies in the US. It will reduce a lot of work for you seeking information and dealing with the regulatory authorities. Then we will bridge those “gaps” and prepare your final 510(k) submission including all the 21 sections inside. As an agency, we can also submit the 510(k) to the FDA and interact with them on your behalf answering their questions, coordinating your payment of fees for submission and furnishing the information they seek. Our aim is to reduce your hassles and help you succeed in launching your device in the US market in a cost-effective and result-oriented manner. At FDAMap, we help accomplish regulatory and compliance objectives of pharma/medical devices/clinical trials companies with our customized training programs and one-on-one consultation with regulatory and compliance experts. Our consultants and trainers have decades of experience in handling complexities in drug and device development, clinical trials, FDA regulatory procedures and compliance, and post approval manufacturing and marketing. For further information, please call us and our customer service would promptly answer your queries about our FDA 510(k) consulting services. For more information on the training, content, instructors, and cost estimates, please contact Prashant Kumar at 410-501-5777 or write to [email protected]. |
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