A blog around what you need to do to initiate a 510K submission and where to start.

When it comes to medical device development, FDA submission requirements and guidance implies device manufacturers have many pre-submission tasks to complete in order to file their 510(k) with the agency.

However, let's be honest: the 510(k) process is intriguing - both for medical device makers as well as individuals with no prior knowledge of the clinical device world.

There's always a good chance you'll come across questions like "where do I find information?", "how do I go about finding resources?", and many others.

What is a 510k submission?

510k submission is the rigorous process of approval by the FDA to market a medical device. The 510k process begins when an applicant files a premarket notification with the FDA and ends when the FDA makes a decision regarding approval or denial. If approved, the applicant may then market their device.

A 510(k) submission is required for medical devices that have not been previously cleared or approved by the FDA to be marketed in the United States. A 510(k) must be filed for each new version of an existing device that has not been modified from its original state. A 510(k) submission is also required if you want to modify your medical device after it was cleared or approved by the FDA under certain circumstances.

The purpose of a 510(k) submission is to determine whether a new product is substantially equivalent (in safety and effectiveness) to an already legally marketed device that has been used safely and effectively for health care purposes for at least 2 years in this country, i.e., whether it presents substantially different questions of safety and effectiveness than those raised by prior submissions on similar products.

510k Submission Process: Who can submit a 510k?

The 510k submission process is one that can be confusing for many companies. It is important to understand who can submit a 510k, how long it will take, and what kind of costs are associated with the process.

In order to submit a 510k, there are two requirements:

1. You must be able to prove that your product is safe for use by patients. This means that if your product has never been tested on humans before, you will need to conduct clinical trials before submitting your application. This is also true if your product has previously been tested on humans but has not yet received FDA approval. If this is the case, then you will need to prove that your product has no dangerous side effects or complications when used in the way that it was intended by the manufacturer.
2. You must have an experienced team who understands how to create and implement a testing plan for all aspects of pre-marketing (or post-marketing) research studies related to your device or implantable device if necessary."

When do I need to submit a 510k?

A 510(k) is a type of premarket notification that is required for some medical devices, including in vitro diagnostics (IVDs) and other devices that are similar to those that have been commercially marketed in the United States prior to May 28, 1976. The 510(k) process is used by the Food and Drug Administration (FDA) to determine whether a new medical device is substantially equivalent to a previously cleared device (predicate). This determination is made through an FDA review of data submitted as part of a 510(k) submission.

If you would like more information or have any questions on the 510k submission process

The 510(k) submission process is a critical step in bringing your medical device to market. The FDA requires all medical devices to be registered with the agency before they can be marketed in the United States. The 510(k) approval process is a streamlined approval process that allows manufacturers to submit premarket notifications for devices that are “substantially equivalent” to an already legally marketed device.

If you would like more information or have any questions on the 510(k) submission process, please contact us at www.i3cglobal.uk