§ 807.92 Content and format of a 510(k) summary., 21 C.F.R. § 807.92
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`Code of Federal Regulations
`Title 21. Food and Drugs
`Chapter I. Food and Drug Administration, Department of Health and Human Services (Refs & Annos)
`Subchapter H. Medical Devices
`Part 807. Establishment Registration and Device Listing for Manufacturers and Initial Importers of
`Devices (Refs & Annos)
`Subpart E. Premarket Notification Procedures
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`21 C.F.R. § 807.92
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`§ 807.92 Content and format of a 510(k) summary.
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`Currentness
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`(a) A 510(k) summary shall be in sufficient detail to provide an understanding of the basis for a determination of substantial
`equivalence. FDA will accept summaries as well as amendments thereto until such time as FDA issues a determination of
`substantial equivalence. All 510(k) summaries shall contain the following information:
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`(1) The submitter's name, address, telephone number, a contact person, and the date the summary was prepared;
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`(2) The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the
`classification name, if known;
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`(3) An identification of the legally marketed device to which the submitter claims equivalence. A legally marketed device
`to which a new device may be compared for a determination regarding substantial equivalence is a device that was legally
`marketed prior to May 28, 1976, or a device which has been reclassified from class III to class II or I (the predicate), or a
`device which has been found to be substantially equivalent through the 510(k) premarket notification process;
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`(4) A description of the device that is the subject of the premarket notification submission, such as might be found in
`the labeling or promotional material for the device, including an explanation of how the device functions, the scientific
`concepts that form the basis for the device, and the significant physical and performance characteristics of the device, such
`as device design, material used, and physical properties;
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`(5) A statement of the intended use of the device that is the subject of the premarket notification submission, including a
`general description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate, including
`a description, where appropriate, of the patient population for which the device is intended. If the indication statements
`are different from those of the legally marketed device identified in paragraph (a)(3) of this section, the 510(k) summary
`shall contain an explanation as to why the differences are not critical to the intended therapeutic, diagnostic, prosthetic,
`or surgical use of the device, and why the differences do not affect the safety and effectiveness of the device when used
`as labeled; and
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`(6) If the device has the same technological characteristics (i.e., design, material, chemical composition, energy source)
`as the predicate device identified in paragraph (a)(3) of this section, a summary of the technological characteristics of the
`new device in comparison to those of the predicate device. If the device has different technological characteristics from the
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` © 2015 Thomson Reuters. No claim to original U.S. Government Works.
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`1
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`Ex. 2032-0001
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`§ 807.92 Content and format of a 510(k) summary., 21 C.F.R. § 807.92
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`predicate device, a summary of how the technological characteristics of the device compare to a legally marketed device
`identified in paragraph (a)(3) of this section.
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`(b) 510(k) summaries for those premarket submissions in which a determination of substantial equivalence is also based on an
`assessment of performance data shall contain the following information:
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`(1) A brief discussion of the nonclinical tests submitted, referenced, or relied on in the premarket notification submission
`for a determination of substantial equivalence;
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`(2) A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission
`for a determination of substantial equivalence. This discussion shall include, where applicable, a description of the
`subjects upon whom the device was tested, a discussion of the safety or effectiveness data obtained from the testing, with
`specific reference to adverse effects and complications, and any other information from the clinical testing relevant to a
`determination of substantial equivalence; and
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`(3) The conclusions drawn from the nonclinical and clinical tests that demonstrate that the device is as safe, as effective,
`and performs as well as or better than the legally marketed device identified in paragraph (a)(3) of this section.
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`(c) The summary should be in a separate section of the submission, beginning on a new page and ending on a page not shared
`with any other section of the premarket notification submission, and should be clearly identified as a “510(k) summary.”
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`(d) Any other information reasonably deemed necessary by the agency.
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`Credits
`[57 FR 18066, April 28, 1992; 57 FR 23059, June 1, 1992; 59 FR 64295, Dec. 14, 1994]
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`SOURCE: 42 FR 42526, Aug. 23, 1977; 51 FR 33032, Sept. 18, 1986; 54 FR 39640, Sept. 27, 1989; 58 FR 46522, Sept. 1,
`1993; 62 FR 51519, Oct. 1, 1997; 66 FR 5466, Jan. 19, 2001; 66 FR 59159, Nov. 27, 2001, unless otherwise noted.
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`AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i, 360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.
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`Notes of Decisions (38)
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`Current through Dec. 3, 2015; 80 FR 75638.
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`End of Document
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`© 2015 Thomson Reuters. No claim to original U.S. Government Works.
`
` © 2015 Thomson Reuters. No claim to original U.S. Government Works.
`
`2
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`Ex. 2032-0002