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Federal Register / Vol. 86, No. 190 / Tuesday, October 5, 2021 / Rules and Regulations
population for which the device is intended. The indications for use include all the labeled patient uses of the device, including if it is prescription or over-the-counter.
6 Device description. A complete description of:
i The device, including, where applicable, pictorial representations, device specifications, and engineering drawings;
ii Each of the functional components or ingredients of the device, if the device consists of more than one physical component or ingredient;
iii The properties of the device relevant to the diagnosis, treatment, prevention, cure, or mitigation of a disease or condition and/or the effect of the device on the structure or function of the body;
iv The principles of operation of the device; and v The relevant FDA assigned reference numbers for any medical devices such as accessories or components that are intended to be used with the device and that are already legally marketed.
7 Alternative practices and procedures. A description of existing alternative practices or procedures that are used in diagnosing, treating, preventing, curing, or mitigating the disease or condition for which the device is intended or which similarly affect the structure or function of the body and that are known or should reasonably be known to the requester.
8 Classification summary. i For devices not the subject of a previous submission under section 510k of the Federal Food, Drug, and Cosmetic Act, a complete description of:
A The searches used to establish that no legally marketed device of the same type exists.
B A list of classification regulations, PMAs, HDEs, premarket notifications 510ks, EUAs, and/or product codes regarding devices that are potentially similar to the subject device.
C A rationale explaining how the device that is the subject of the De Novo request is different from the devices covered by the classification regulations, PMAs, HDEs, 510ks, EUAs, and/or product codes identified in paragraph a8iB of this section.
ii For devices which were the subject of a previous submission under section 510k of the Federal Food, Drug, and Cosmetic Act that were determined not substantially equivalent NSE, the relevant 510k number, along with a summary of the search performed to confirm the device has not been classified or reclassified since the
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date the NSE order was issued by FDA
pursuant to 807.100a of this chapter.
9 Summary of risks and mitigations.
A summary of probable risks to health associated with use of the device that are known or should reasonably be known to the requester and the proposed mitigations, including general controls and, if the classification recommendation from paragraph a11
of this section is class II, special controls for each risk. For each mitigation measure that involves specific performance testing or labeling, the De Novo request must provide a reference to the associated section or pages for the supporting information in the De Novo request.
10 Proposed special controls. If the classification recommendation from paragraph a11 of this section is class II, then the summary must include an initial draft proposal for applicable special controls and a description of how those special controls provide reasonable assurance of safety and effectiveness.
11 Classification recommendation.
The recommended class I or II must be identified and must be supported by a description of why general controls, or general and special controls, are adequate to provide reasonable assurance of safety and effectiveness.
12 Standards. Reference to any published voluntary consensus standards that are relevant to any aspect of the safety or effectiveness of the device and that are known or should reasonably be known to the requester.
Such standards include voluntary consensus standards whether recognized or not yet recognized under section 514c of the Federal Food, Drug, and Cosmetic Act. Provide adequate information to demonstrate how the device meets, or justify any deviation from, the referenced standard.
13 Summary of studies. An abstract of any information or report described in the De Novo request under paragraph a16ii of this section and a summary of the results of technical data submitted under paragraph a15 of this section. Each such study summary must include a description of the objective of the study, a description of the experimental design of the study, a brief description of how the data were collected and analyzed, and a brief description of the results, whether positive, negative, or inconclusive. This section must also include the following:
i A summary of each nonclinical study submitted in the De Novo request;
ii A summary of each clinical investigation involving human subjects submitted in the De Novo request, including a discussion of investigation
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design, subject selection and exclusion criteria, investigation population, investigation period, safety and effectiveness data, adverse reactions and complications, subject discontinuation, subject complaints, device failures including unexpected software events, if applicable and replacements, results of statistical analyses of the clinical investigations, contraindications and precautions for use of the device, and other information from the clinical investigations as appropriate. Any investigation conducted under an investigational device exemption IDE
under part 812 of this chapter must be identified as such.
14 Benefit and risk considerations. A
discussion demonstrating that:
i The data and information in the De Novo request constitute valid scientific evidence within the meaning of 860.7c and ii Pursuant to 860.7, when subject to general controls, or general and special controls, the probable benefit to health from use of the device outweighs any probable injury or illness from such use.
15 Technical sections. The following technical sections, which must contain data and information in sufficient detail to permit FDA to determine whether to grant or decline the De Novo request:
i A section containing the results of the nonclinical studies of the device, including, as appropriate, microbiological, toxicological, immunological, biocompatibility, stress, wear, shelf life, electrical safety, electromagnetic compatibility, and other laboratory or animal tests. Information on nonclinical studies must include protocols and complete test reports for each study. For those nonclinical studies subject to part 58 of this chapter, this section must include a statement that each such study was conducted in compliance with such regulations, or, if the study was not conducted in compliance with part 58 of this chapter, a brief statement of the reason for the noncompliance.
ii For all devices that incorporate software, a section containing all relevant software information and testing, including, but not limited to, appropriate device hazard analysis, hardware, and system information.
iii A section containing results of each clinical investigation of the device involving human subjects, including clinical protocols, number of investigators and subjects per investigator, investigation design, subject selection and exclusion criteria, investigation population, investigation period, safety and effectiveness data, adverse reactions and complications,
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