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Code of Federal Regulations (Last Updated: November 8, 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 860 - Medical Device Classification Procedures |
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Subpart D - De Novo Classification |
| § 860.200 - Purpose and applicability. |
| § 860.210 - De Novo request format. |
| § 860.220 - De Novo request content. |
| § 860.230 - Accepting a De Novo request. |
| § 860.240 - Procedures for review of a De Novo request. |
| § 860.250 - Withdrawal of a De Novo request. |
| § 860.260 - Granting or declining a De Novo request. |