FDA Issues Draft Guidance on Changes to Products Covered By a 510(K)

On July 27, 2011 FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) issues a draft guidance document on when to submit a 510(k) for a change to an existing device.

This draft guidance is one of 25 specific actions that FDA intends to improve the premarket review programs. When issued, the guidance will replace the 1997 version, Deciding When to Submit a 510(K) for a Change to and Existing Device.

Among the drivers for change include the Quality System Regulation (QSR), issued after the 1997 guidance, software issues, and other rapidly changing technologies.

The 1997 version uses a decision process driven by a set of flowcharts. The draft guidance eliminates the flowcharts, but uses a large number of examples to illustrate the principles.

The guidance documents help manufacturers to implement 21 CFR §807.81(a)(3). That require a 510(k) submission when:

  1. 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:
    1. 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.
    2. A major change or modification in the intended use of the device.

The draft guidance addresses the following areas:

  • Manufacturing Process Changes
  • Labeling Changes
  • Technology, Engineering, and Performance Changes
  • Materials Changes
  • Is Clinical Data Necessary to Determine Substantial Equivalence?

The draft guidance document stresses that the manufacturer should not evaluate each change alone, but in context with any earlier changes. The idea is to compare the device, after the proposed change, with the current cleared 510(k) for the device. This ensures that the proposed change includes the cumulative impact of all changes.

Each section, except the last, includes a series of questions, explanations, and example. For example, Technology, Engineering, and Performance Changes asks, “Is it a change in energy type?” the explanation includes, “Energy type refers to the type of power input to or output from the device.” The example tells us “A device that is changed from an external power source to battery power should result submission of a new 510(k).”

You may get a copy of the draft guidance using the search engine at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.

You may comment on the draft through [FR Doc No: 2011-18923] at http://www.regulations.gov.