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FDA Clarifies Substantial Equivalence Requirements for 510(k) Submissions


Indications for Use and Intended Use

These two terms are often used inconsistently or interpreted differently among people. Intended use describes the purpose or function of the device, and indications for use describes the disease or condition the device will treat (including intended patient population). The intended use encompasses indications for use. To show substantial equivalence, your device’s indications must fall under the predicate device’s intended use.

FDA explains when different indications for use would preclude a predicate comparison and precipitate a new intended use. In determining substantial equivalence, the reviewer may have concerns that 1) FDA did not see with the predicate or 2) the predicate cannot be generalized to include the new indications of your device due to a “probable, significant change in the incidence or severity of the issue.”

The guidance documentation provides examples of changes that may require a new intended use:
- Changes in patient populations (e.g. adult vs. pediatric)
- Changing an indication’s anatomical structure of use
- Changing a functional indication to a treatment indication
- Changing a diagnostic indication to a screening indication
- Changed clinical contexts or settings

A new intended use would result in a not substantially equivalent (NSE) decision for your device, although this is a relatively rare reason for NSE findings.

Substantial Equivalence Pathway

Once FDA has determined that your identified predicate device(s) is (are) acceptable, the reviewer will next compare the technological characteristics in order to assess the risks and benefits. Technological characteristics are details such as material, design, energy source (if applicable), density, porosity, degradation characteristics and other features.

After the identification of the characteristics, the reviewer will assess the differences between your device and the predicate device(s). If there are any differences, the reviewer will determine if your device raises concerns of safety and effectiveness. Exhibit 1 illustrates the overall decision making flowchart from the guidance document.

Exhibit 1: 510(k) Decision Making Flow Chart as Adapted from FDA Guidance

510k-Decision-Making-Flowchart1000-9-2-14 WEB
(Click on the image for a larger view.)

NSE = not substantially equivalent

IFU = indications for use


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