Why do You need To File A CER & 510K Submission For Your Medical Products?

A 510(k) is a premarket submission to the FDA that demonstrates that the device to be marketed is as safe and effective as a legally marketed device (section 513(i)(1)(A) FD&C Act). 510k Consultants can assist you in understanding the FDA's regulatory requirements for marketing your device. The FDA's 510k process allows medical device manufacturers to demonstrate that their device is safe and effective in comparison to an equivalent device.

Filing a Premarket Notification with the FDA, also known as an FDA 510(k) submission, is one of the first steps toward selling a Class II medical device or IVD in the United States. Under the 510(k) process, the FDA does not "approve" medical devices or IVDs for sale; rather, it grants "clearance" for them to be sold in the United States. The terms "FDA approval" and "FDA clearance" are used in a way that can exchange their meaning. The 510(k) regulatory clearance is valid until changes to the product, intended use, or indications for use are implemented. Changes must be evaluated to determine whether they warrant a new FDA submission.

Who is required to file an FDA 510(k) premarket notification?

In general, manufacturers who want to introduce Class II medical devices (and a few Class I and III devices) or IVDs to the US market must file a 510(k) with the FDA. A 510(k) premarket notification is also required for manufacturers who change the intended use of their medical device or change the technology of a cleared device in such a way that the device's safety or effectiveness may be significantly impacted.

At Thomas Regulatory Resolutions, we want you to have a successful launch of your device in the US market. We have successfully prepared and submitted FDA 510(k) submissions for medical device and IVD companies from around the world that are seeking to sell in the United States.

Need Of Clinical Evaluation Report

At Thomas Regulatory Resolutions, our Clinical Evaluation Report Consultants will provide you with the perfect support and assistance to get a positive CER report for your medical devices. A Clinical Evaluation Report (CER) includes the final documents of your medical device's clinical evaluation. The components of a CER are the results of the analyzed clinical data from the clinical investigation of your device or other studies on equivalent devices. 

The CER demonstrates that your device achieves its intended purpose without endangering users or patients. Clinical Evaluation Reports are required in Europe for all medical devices. You must attach your CER to your European CE Technical File and submit it to your Notified Body. The Technical File is a necessary step in obtaining CE Marking for your device, which is required in Europe to sell or distribute medical devices. Thomas Regulatory Resolutions also provide the best FDA COVID-19 Coronavirus SARS-COV-2 Consultants that can be quite helpful in getting an FDA Covid-19 clearance for your medical devices or products making your products to be safe for use.

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