21 CFR 25.34 - Devices and electronic products

Cite as21 CFR 25.34
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386 practice notes
2 cases
  • Int'l Acad. of Oral Med. & Toxicology v. U.S. Food & Drug Admin., Civil Action No. 14-356 (JEB)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • 1 d5 Julho d5 2016
    ...amalgam would not "increase [ ] ... the existing levels of use of the device or change[ ] ... [its] intended use." Id. at 38704 (citing 21 C.F.R. § 25.34, which sets forth the conditions under which FDA need not complete an EA or EIS, as would ordinarily be required by NEPA).Another Citizen......
  • Int'l Acad. of Oral Med. & Toxicology v. U.S. Food & Drug Admin., Civil Action No. 14-356 (JEB)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • 1 d5 Julho d5 2016
    ...would not "increase[] . . . the existing levels of use of the device or change[] . . . [its] intended use." Id. at 38704 (citing 21 C.F.R. § 25.34, which sets forth the conditions under which FDA need not complete an EA or EIS, as would ordinarily be required by NEPA). Another Citizen Petit......

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