21 CFR 809.3 - Definitions
| Cite as | 21 CFR 809.3 |
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12 practice notes
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Murphy Med. Assocs. v. Cigna Health & Life Ins. Co., CIVIL 3:20cv1675(JBA)
...conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.” 21 C.F.R. § 809.3. [4] The court in Diagnostic Affiliates found a private right of action within § 3202 of the CARES Act. 2022 WL 214101, at *9. It concluded......
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based products: Donors suitability determination,
...transfer into a human recipient. The agency is also adding language to specifically exclude in vitro diagnostic products as defined in 21 CFR 809.3(a) from the definition of human cellular or tissue-based product. In addition, the agency is deleting the reference in Sec. 1271.3(e) to the re......
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U.S. v. Undetermined No. of Unlabeled Cases, No. 92-3458
...preparation, and examination of specimens taken from the human body," explicitly ties diagnosis with later medical treatment. See 21 C.F.R. Sec. 809.3(a) (in vitro diagnostic products "intended for use in the diagnosis of disease or other conditions, including a determination of the state o......
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Biological products: human globulin and blood grouping reagents; requirements,
...Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321), and fall within the definition of in vitro diagnostic products in Sec. 809.3(a) (21 CFR 809.3(a)). AHG and BGR must meet the licensing requirements of section 351 of the PHS Act and the regulations in parts 600 through 660 (21 CFR part......
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2 cases
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Murphy Med. Assocs. v. Cigna Health & Life Ins. Co., CIVIL 3:20cv1675(JBA)
...conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.” 21 C.F.R. § 809.3. [4] The court in Diagnostic Affiliates found a private right of action within § 3202 of the CARES Act. 2022 WL 214101, at *9. It concluded......
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U.S. v. Undetermined No. of Unlabeled Cases, No. 92-3458
...preparation, and examination of specimens taken from the human body," explicitly ties diagnosis with later medical treatment. See 21 C.F.R. Sec. 809.3(a) (in vitro diagnostic products "intended for use in the diagnosis of disease or other conditions, including a determination of the state o......
3 firm's commentaries
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The LDT Debate: Understanding FDA’s Jurisdiction Over IVDs Made at a Clinical Lab
...are actually doing in their labs. That analysis is not furthered by generalizations, but by specifics. ENDNOTES [1] 21 U.S.C. 321(h) [2] 21 CFR 809.3 [3] https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/LDT-and-CLIA_FAQs.pdf [4] Further, FDA law has long held that int......
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An Update on FDA’s Contribution to COVID-19 Diagnostic Testing
...applicable statutes.” This may make more intuitive sense if one knows that the legal definition of an in vitro diagnostic, found at 21 C.F.R. § 809.3, includes devices "intended for use in the collection and/or preparation of specimens taken from the human body." Accordingly, any clinical l......
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Dueling Records: Are Statements in Your 510(k) Putting Your Patents at Risk?
...in this definition in vitro diagnostic tests that are not essential to the safe and effective use of a therapeutic product. Id. 6 21 C.F.R. § 809.3. 7 U.S. Food and Drug Administration, supra note 2, at 8 U.S. Department of Health and Human Services, U.S. Food and Drug Administration, Cente......
7 provisions
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based products: Donors suitability determination,
...transfer into a human recipient. The agency is also adding language to specifically exclude in vitro diagnostic products as defined in 21 CFR 809.3(a) from the definition of human cellular or tissue-based product. In addition, the agency is deleting the reference in Sec. 1271.3(e) to the re......
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Biological products: human globulin and blood grouping reagents; requirements,
...Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321), and fall within the definition of in vitro diagnostic products in Sec. 809.3(a) (21 CFR 809.3(a)). AHG and BGR must meet the licensing requirements of section 351 of the PHS Act and the regulations in parts 600 through 660 (21 CFR part......
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Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
...amended by section 3201 of the CARES Act, requires plans and issuers to provide coverage for an in vitro diagnostic test, as defined in 21 CFR 809.3(a) (or its successor regulations), for the detection of SARS-CoV-2 or diagnosis of COVID-19, and the administration of such a test that: (1) I......
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Biological products: human globulin and blood grouping reagents; requirements,
...and Cosmetic Act (the act) (21 U.S.C. 321), and fall within the definition of in vitro diagnostic (IVD's) products in Sec. 809.3(a) (21 CFR 809.3(a)). AHG and BGR must meet the licensing requirements of section 351 of the PHS Act and the regulations in parts 600 through 660 (21 CFR parts 60......
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