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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 814 - Premarket Approval of Medical Devices |
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Subpart C - FDA Action on a PMA |
| § 814.40 - Time frames for reviewing a PMA. |
| § 814.42 - Filing a PMA. |
| § 814.44 - Procedures for review of a PMA. |
| § 814.45 - Denial of approval of a PMA. |
| § 814.46 - Withdrawal of approval of a PMA. |
| § 814.47 - Temporary suspension of approval of a PMA. |