510k Submission Process and Checklist – I3CGLOBAL

1. 510k Submission Process and Checklist – I3CGLOBAL It's Time to Get Your Medical Device 510k Submitted and Approved. You've designed your medical device and are ready to get it to market. But before you take that step, it is important to understand the process for approval for marketing in the US. What is a 510(k)? The 510(k) is a form that describes the design, functions, intended use, and performance characteristics of your medical device. It also describes how your product compares with other similar devices already on the market. The FDA uses this information to decide whether your product needs additional testing before it can be sold commercially in the U.S. The FDA Registration has an online database that tracks submissions made under section 510(k). This database includes information about each submission, including its status (i.e., pending review or approved). Here is the link…. 510k Submission Process for Medical Devices 510k submissions are required for medical devices. They are submitted to the FDA and have to be approved before a product can be sold in the United States. Note: If you plan to market a new medical device in the United States, you'll need to file a premarket notification called a "510(k)" with the Food and Drug Administration (FDA). The 510(k) is a short form that requires you to describe how your product is similar to an existing device that is already on the market. You can skip some of the requirements if your product does not pose an unreasonable risk of illness or injury. In order to submit a 510(k), there are three basic steps: Conduct an adequate review of publicly available information on pre-amendment devices (a "510(k)" search). Develop an adequate reason to believe that your device is substantially equivalent to one of those pre-amendment devices that has been shown by substantial evidence or experience to be safe and effective for its intended use. Submit your 510(k) application to FDA for review and clearance for marketing in the United States." FDA 510k Requirements The FDA has set up regulations that all medical device manufacturers must meet. These include:

2. A premarket notification must be filed with the FDA at least 90 days before marketing, unless an exception applies. The PMN must include a summary of the device; a description of its design, composition, and methods of manufacture; a detailed explanation of the processes used to manufacture the device; an explanation of any substantial changes in design or manufacturing process since the last submission; and information about clinical data showing safety and effectiveness when applicable. 510k submission checklist There are several steps involved in preparing and submitting a 510(k) application. The following checklist is designed to serve as a guide for submitting your device using the 510(k) process. You should print out this checklist, fill out each section, and then submit it along with your application. The following information is required for submission: Company name and contact information Name of product and the purpose for which it is used A description of the device, including its dimensions, materials used, and any special features that make it unique An overview of the manufacturing process, including how the product is tested and how you ensure quality control throughout production A summary of any clinical data on the safety and efficacy of your device as well as any related studies or tests you have performed (if applicable) 510k Approval Timeline The 510k approval process can be a long one, but it's not something you should be afraid of. In general, the FDA recommends that you don't expect to hear back from them within 60 days of submitting your application. However, if you do get a response within that time frame, there's a good chance it will be just a "no" or "not yet." The FDA takes about 180 days on average to review applications, but it can take longer than that if the agency requires more information or additional testing before moving forward with an approval.

3. The time it takes for your company's 510k approval will depend on several factors: The complexity of your product How many other companies are waiting for approval at the same time Whether or not you have any issues that need to be addressed during the approval process If you're just starting out, you should know that there are three parts to your application: An initial review period lasting 30 days where the FDA will conduct a preliminary review of your application to make sure it's complete and accurate. During this period, they will request any additional information needed in order to complete the initial review. A secondary review period lasting 90 days where the FDA will perform an in-depth review of your application to ensure that all necessary information has been provided and all required actions have been taken by both parties (you and the FDA). This is when most questions or concerns are addressed before final approval is given. A post-market surveillance period lasting up to 5 years after initial marketing begins for new devices or reclassification of existing ones as Class II devices (Class III if already approved). This is where companies must report any adverse events or other issues associated with their product(s) so that these can be monitored by the FDA for any potential