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US FDA 510(k): Best Practices for 510(k) Preparation and Submission
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Section 7.0: Device Description
Section 7.0 Device Description
(As required by 21 CFR § 807.92(a)(4))
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Section 7.0: Device Description (Cont.) Section 7.0: Device Description Section 7.1: Introduction In this section, as required by 21 CFR 807.92(a)(4), we present 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, materials used, physical, chemical and biological properties. Section 7.1.1: • • • •
Regulatory Information Regulation(s) applicable Device name (trade name and common name) Device classification Product code.
The description of the device attributes in detail is shown below.
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Section 7.0: Device Description (Cont.) 7.2: Device Description 7.2.1: Principle of Operation 7.2.2: Mechanism of Action 7.2.3: Key device Features (labeled diagrams, photographs or pictures, engineering drawings, schematics including all internal and external, assembled and unassembled, interchangeable, parts of the device with their name and function. The length, width, height, diameter, etc., of the device should be included. 7.2.4: Energy Source And Other Device Features 7.3: Device Identification Under this section, the following key device components are described. In addition, all the model numbers (if known) are provided with detailed explanation of the differences among the models.
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Section 7.0: Device Description (Cont.) 7.4: Device Characteristics 7.4.1: 7.4.2: 7.4.3: 7.4.4: 7.4.5: 7.4.6: 7.4.7: 7.4.8: 7.4.9:
Drugs, If Applicable. Software, If Applicable. Biologics, If Applicable. Coatings, If Applicable. Single Use, If Applicable. Metals, If Applicable. Additives, If Applicable. (Non)sterile, If Applicable. Sterilization Method, If Applicable.
7.5: Environment of Use 7.5.1: Healthcare Facility/Hospital 7.5.2: Home, Ambulatory or Other
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Section 7.0: Device Description (Cont.) 7.6: Materials of Use 7.6.1:
General Type of Material Used. • Recombinantly-produced polymer • polymer (e.g., plastic or rubber) • Polysulfone • Metal • Stainless steel, etc.
7.6.2: Duration And Type of Contact. If the FDA recognized consensus standard(s) for medical use are used, provide the info at least (ASTM F####-last-2 numbers of the year). Note: ASTM: American Society for Testing and Materials; Now it is renamed as ASTM International.
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