What is Premarket Notification 510(k)

Premarket Notification

Each person who wants to market in the U.S., a Class I, II, and III devices intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a premarket notification 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9)

510k requirements

                                    premarket notification

What is Substantial Equivalence?

A 510(k) requires a demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate.

A device is substantially equivalent if, in comparison to a predicate it:

  • has the same intended use as the predicate; and
  • has the same technological characteristics as the predicate;
    or
  • has the same intended use as the predicate; and
  • has different technological characteristics and does not raise different questions of safety and effectiveness; and
  • the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device

When a premarket notification 510(k) is Not Required?

The following are examples of when a 510(k) is not required.

  1. You sell unfinished devices to another firm for further processing or sell components to be used in the assembling of devices by other firms. However, if your components are to be sold directly to end-users as replacement parts, a 510(k) is required.
  2. Your device is not being marketed or commercially distributed. You do not need a 510(k) to develop, evaluate, or test a device. This includes clinical evaluation. Please note that if you perform clinical trials with your device, you are subject to the Investigational Device Exemption (IDE) regulation (21 CFR 812).
  3. You distribute another firm’s domestically manufactured device. You may place a label on the device, “Distributed by ABC Firm” or “Manufactured for ABC Firm,” (21 CFR 801.1) and sell it to end users without submission of a 510(k).
  4. In most cases, if you are a repackager or a relabeled and the existing labeling or condition of the device is not significantly changed. The labeling should be consistent with the labeling submitted in the 510(k) with the same indications for use and warnings and contraindications.
  5. Your device was legally in commercial distribution before May 28, 1976, and has not been significantly changed or modified in design, components, method of manufacture, or intended use. These devices are “grandfathered” and you have Preamendment Status documentation to prove this.

510(k) Forms

Source: FDA.gov

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