Once you have a device with a 510(k) clearance, you can start production. As your product gets into the marketplace, and feedback starts coming in, you may decide that changes are needed to make it a “better” product. While you are allowed to continually improve your product, some changes might have bigger impact than others. Before continuing with your intended changes, you will need to determine if you only need to document the change(s) or if you will need to create a brand new 510(k) submission.
According to the FDA, “the regulatory criteria state that a premarket notification must be submitted when:
(3) The device is one that the person currently has in commercial distribution or is reintroducing into commercial distribution, but that is about to be significantly changed or modified in design, components, method of manufacture, or intended use. The following constitute significant changes or modifications that require a premarket notification:
(i) A change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.
(ii)A major change or modification in the intended use of the device.”
Examples of modifications that may require a 510(k) submission include, but are not limited to, the following:
- Sterilization method
- Material changes
- Manufacturing method
- Indications for use
- Patient or user safety features
- Stability or expiration claims
Luckily, the FDA has provided us with tools to help make this decision clearer. In a memorandum (K97-1), they go into step-by-step details, provide four different flowcharts (see below), and give definitions/explanations for each decision point on those flowcharts. If it is decided that a new 510(k) submission is not required, this decision will need to be documented (with justification and supporting materials) and retained with the 510(k) paperwork for that device.