Food and Drug Administration
Food and Drug Administration's Categorical Exclusions (opens in new tab)Categorical Exclusion
§25.34 Devices and electronic products.
Exclusion Text
(b) Classification or reclassification of a device under part 860 of this chapter, including the establishment of special controls, if the action will not result in increases in the existing levels of use of the device or changes in the intended use of the device or its substitutes.
Disclaimer
This CE Explorer tool is not an authoritative source and creates no rights or obligations. When using the CE Explorer Tool, Federal agencies and stakeholders should review the relevant agency's NEPA procedures for information about how to apply the CE, including any limitations or potential extraordinary circumstances, and to ensure that a CE is current and applicable to a given proposed action. For ease of use, a link to each agency's NEPA procedures and CEs is provided along with the text of the CE. To adopt and use another agency's categorical exclusion, an agency must follow the steps described in section 109 of NEPA, 42 U.S.C. 4336c.
