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Home Page > Executive Branch > Code of Federal Regulations > Electronic Code of Federal Regulations
e-CFR Data is current as of November 10, 2009
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
Subpart A--GENERAL
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| Confidentiality of data and information in a premarket approval application (PMA) file. |
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| Research conducted outside the United States. |
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| Product development protocol (PDP). |
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Subpart B--PREMARKET APPROVAL APPLICATION (PMA)
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| PMA amendments and resubmitted PMA's. |
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Subpart C--FDA ACTION ON A PMA
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| Time frames for reviewing a PMA. |
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| Procedures for review of a PMA. |
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| Denial of approval of a PMA. |
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| Withdrawal of approval of a PMA. |
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| Temporary suspension of approval of a PMA. |
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Subpart D--ADMINISTRATIVE REVIEW--[RESERVED]
Subpart E--POSTAPPROVAL REQUIREMENTS
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| Postapproval requirements. |
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Subparts F-G--[RESERVED]
Subpart H--HUMANITARIAN USE DEVICES
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| Designation of HUD status. |
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| HDE amendments and resubmitted HDE's. |
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| Supplemental applications. |
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| Timeframes for reviewing an HDE. |
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| Procedures for review of an HDE. |
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| Denial of approval or withdrawal of approval of an HDE. |
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| Temporary suspension of approval of an HDE. |
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| Confidentiality of data and information. |
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| Institutional Review Board requirements. |
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| Postapproval requirements and reports. |
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