21 C.F.R. PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES
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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