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DEVICE RAC EXAM 2025 QUESTIONS AND ANSWERS.
DEVICE RAC EXAM 2025 QUESTIONS AND ANSWERS.
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2025/2026 Tests
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2025/2026 Tests
DEVICE RAC EXAM 2025 QUESTIONS AND ANSWERS.
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| Uploaded on: | September 9, 2025 |
| Last updated: | September 9, 2025 |
| Number of pages: | 28 |
| Written in: | 2025/2026 |
| Type: | Exam (elaborations) |
| Contains: | Questions & Answers |
| Tags: | DEVICE RAC EXAM 2025 QUESTIONS AND ANSWERS. |
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Page | 1 DEVICE RAC EXAM 2025 QUESTIONS AND ANSWERS. 1. If your firm commercially distributes a Class III device that is subject to PMA requirements without an approved Pre-market Approval Application, what is the statutory violation? A) Adulteration B) Improper Use C) Misbranding D) Idiocy - correct answer - A 2. Pre-market Notification Requirements would apply to a device that is: A) Substantially equivalent to a pre-amendment device B) Intended solely for use by a specific physician C) Not equivalent to currently marketed devices D) Intended for veterinary use - correct answer - A 3. You have just been hired as Director of Regulatory Affairs at a contract sterilizer from a similar position at a surgical instrument manufacturer and are reviewing your firms' records. You haven't come across any device listing forms for the
