21 CFR 3.2 - Definitions

Cite as21 CFR 3.2
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56 practice notes
  • Submission of Food and Drug Administration Import Data in the Automated Commercial Environment
    • United States
    • Federal Register July 01, 2016
    • July 1, 2016
    ...center with primary jurisdiction for the premarket review and regulation of the combination product. A combination product is defined in 21 CFR 3.2(e). CDRH may have primary jurisdiction over the following types of combination products with IND numbers: Investigational drug/device or invest......
  • Clinical Trials Registration and Results Submission
    • United States
    • Federal Register November 21, 2014
    • November 21, 2014
    ...propose to treat certain clinical trials of combination products as applicable drug clinical trials. Combination products are defined in 21 CFR 3.2(e). A combination product is comprised of a drug and device; a biological product and device; a drug and biological product; or a drug, biologi......
  • Angiotech Pharm. Inc. v. Lee, Case No. 1:15-cv-1673
    • United States
    • United States District Courts. 4th Circuit. United States District Court (Eastern District of Virginia)
    • June 8, 2016
    ...therapeutic attributes "that are physically, chemically, or otherwise combined or mixed and produced as a single entity." 21 C.F.R. § 3.2(e). When reviewing a combination product, the FDA first determines the product's "primary mode of action," which refers to the one me......
  • Genus Med. Techs., LLC v. U.S. Food & Drug Admin., Civil Action No. 19-544 (JEB)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • December 6, 2019
    ..."regulated components," such as a drug component and a device component, that are "produced as a single entity." 21 C.F.R. § 3.2(e)(1). Take, for example, a surgical mesh with anesthetic coating, which has a device component (the mesh) and a drug component (the anestheti......
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10 cases
  • Coyne Beahm, Inc. v. U.S. Food & Drug Admin., No. 2:95CV00591.
    • United States
    • United States District Courts. 4th Circuit. Middle District of North Carolina
    • April 25, 1997
    ...(f) Device has the meaning given the term in [21 U.S.C. § 321(h)]. (g) Drug has the meaning given the term in [21 U.S.C. § 321(g)]. 21 C.F.R. § 3.2. FDA avows that it routinely regards the following products as combination products: pre-filled delivery systems, such as pre-filled syringes, ......
  • Genus Med. Techs., LLC v. U.S. Food & Drug Admin., Civil Action No. 19-544 (JEB)
    • United States
    • United States District Courts. United States District Court (Columbia)
    • December 6, 2019
    ...comprises two or more "regulated components," such as a drug component and a device component, that are "produced as a single entity." 21 C.F.R. § 3.2(e)(1). Take, for example, a surgical mesh with anesthetic coating, which has a device component (the mesh) and a drug component (the anesthe......
  • Angiotech Pharm. Inc. v. Lee, Case No. 1:15-cv-1673
    • United States
    • United States District Courts. 4th Circuit. United States District Court (Eastern District of Virginia)
    • June 8, 2016
    ...products—have therapeutic attributes "that are physically, chemically, or otherwise combined or mixed and produced as a single entity." 21 C.F.R. § 3.2(e). When reviewing a combination product, the FDA first determines the product's "primary mode of action," which refers to the one means by......
  • Prevor v. U.S. Food & Drug Admin., Civil Action No. 13–1177 RMC
    • United States
    • United States District Courts. United States District Court (Columbia)
    • September 9, 2014
    ...or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity.” 21 C.F.R. § 3.2(e)(1).To determine whether a combination product is to be regulated as a drug or a device, FDA must analyze the constituent parts of the product to dete......
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13 firm's commentaries
  • FDA Issues Its First Postmarketing Safety Reporting Regulations For Combination Products
    • United States
    • Mondaq United States
    • March 31, 2017
    ...for Combination Products, 81(244) Fed. Reg. 92603-92626 (Dec. 20, 2016) (to be codified at 21 C.F.R. pt. 4) ("Final Rule"); see also 21 C.F.R. § 3.2(e) (defining "combination product" as, inter alia, a product comprised of two or more regulated components). The rule has an effective date of......
  • FDA Proposes To Amend Product Jurisdiction Regulations Without Any Significant Substantive Changes
    • United States
    • Mondaq United States
    • June 13, 2018
    ...(CDER) based upon which Center regulates that the type of the biological product. The proposed rule also updates several definitions at 21 C.F.R. § 3.2 and provides a cross-reference to certain other sections to enhance clarity and completeness. Further, the proposed rule removes redundant,......
  • FDA Proposed Rule On Product Jurisdiction
    • United States
    • Mondaq United States
    • June 6, 2018
    ...Center that regulates the constituent part providing the primary mode of action. The definition of "biological product mode of action" in 21 CFR 3.2 would be amended to align with the definition of "biological product" in 42 USC 262(i) and specify that proteins (except chemically synthesize......
  • FDA Public Meeting to Discuss Task Force Report
    • United States
    • LexBlog United States
    • August 18, 2008
    ...(including a drug constituent part of a combination product) but cannot be a “device” (including a device constituent part) (21 USC 321(h), 21 CFR 3.2). Do you believe that any nanoscale therapeutic articles, including constituent parts of combination products, interact with the body in way......
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32 provisions
  • Clinical Trials Registration and Results Submission
    • United States
    • Federal Register November 21, 2014
    • November 21, 2014
    ...propose to treat certain clinical trials of combination products as applicable drug clinical trials. Combination products are defined in 21 CFR 3.2(e). A combination product is comprised of a drug and device; a biological product and device; a drug and biological product; or a drug, biologi......
  • Submission of Food and Drug Administration Import Data in the Automated Commercial Environment
    • United States
    • Federal Register July 01, 2016
    • July 1, 2016
    ...center with primary jurisdiction for the premarket review and regulation of the combination product. A combination product is defined in 21 CFR 3.2(e). CDRH may have primary jurisdiction over the following types of combination products with IND numbers: Investigational drug/device or invest......
  • Clinical Trials Registration and Results Information Submission
    • United States
    • Federal Register September 21, 2016
    • September 21, 2016
    ...Act, as well as a drug (including a biological product) subject to section 505 of the FD&C Act or section 351 of the PHS Act (see 21 CFR 3.2(e)). Drugs (including biological products) and devices do not lose their discrete regulatory identities when they become constituent parts of a co......
  • Unique Device Identification System
    • United States
    • Federal Register July 10, 2012
    • July 10, 2012
    ...system, a combination product will involve at least one device and at least one drug or one biological product. The term is defined by 21 CFR 3.2(e), and would have the same meaning here. A combination product whose primary mode of action is that of a device is subject to UDI labeling requi......
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