BRG is one of the famous companies that is providing high-quality medical instruments, health care information, and other scientific services. We are an experienced company and also our employees are having good knowledge of the field. The FDA De Novo request provides the easy step to classify novel medical devices. This kind of process is completely based on the risk. The controls like the general and also the general plus special are the interesting ones to classify and that will give the assurance of safety and effectiveness. The marketing of the de nova classification will be for the assurance that there is no legally marketed predicate device.

How to prepare a de novo request?

The request of the de novo for the FDA is available in the two options. This is important for the viewers to notice as this will be the useful one in the future. The option of high level and not substantially equivalent on behalf of the 510(K) submission is the first one. The second option is that the substantial equivalence is the important one but on the medical device that is medically marketed there you will not find anything. This is also according to the request of the customers. Thus without the 510(k) submission and also getting the high-level NSE determination the request of FDA de Novo is made.

How easy is it to send a request?

These requests are obtained from our company’s service and that is more convenient for the clients. This kind of classification will help the industries to know about the low to medium-risk devices. The classification of the devices like classes I, II, and III is determined with the help of the Food and drugs administration. This will happen during the review of the 510(k) applications which are not substantially equivalent. We are always ready to provide their service to make any of the devices to be classified to avoid future risks.

Why the device should match with the FDA de novo classification?

The device manufacturers for the hotels, hospitals, and the other industries under food and drug administration should have to classify it. This kind of classification is the important one for manufacturing the FDA equivalent device without submitting any of the 501(k) applications. The result of the classification will be within thirty days or else the device manufacture can ask FDA about whether the device is properly working without filing the 501(k). This is for the safety and the effectiveness and so the FDA de novo request will be the beneficial one.

Source: https://medium.com/@BiotechResearchGroup/why-you-should-know-about-...