RAC Prep Medical Devices Q&A Latest Update
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RAC
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RAC
RAC Prep Medical Devices Q&A Latest Update
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| Uploaded on: | April 28, 2025 |
| Last updated: | May 3, 2025 |
| Number of pages: | 21 |
| Written in: | 2025/2026 |
| Type: | Exam (elaborations) |
| Contains: | Questions & Answers |
| Tags: | RAC Prep Medical Devices Q&A Latest Update |
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RAC Prep Medical Devices | Q&A Latest Update 2025/2026 | 100% PASS device - Answer -instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent or related article: -recognized by NF-USP -intended for use in diagnosis of disease or other condition, or in the cure, mitigation, treatment or prevention of disease -intended to affect the structure or function of the body -not achieving any primary purpose through chemical action -not dependent on metabolism for primary purpose Exempt device - Answer -Exempt from 510(k) if: -Diagnostic device that was in distribution before 28MAY76, not a transitional device -is noninvasive -does not introduce energy into subject -not used for diagnosis without confirmation from another procedure More than 800 generic class I devices and 60 class II devices (documented in 21CFR 862-892)
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