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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 888 - Orthopedic Devices |
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Subpart E - Surgical Devices |
§ 888.4800 - Template for clinical use.
Latest version.
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§ 888.4800 Template for clinical use.
(a) Identification. A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]