Part 814 Premarket Approval of Medical Devices

Subpart A - General

• § 814.1   Scope
• § 814.2   Purpose
• § 814.3   Definitions
• § 814.9   Confidentiality of data and information in a premarket approval application (PMA) file
• § 814.15   Research conducted outside the United States
• § 814.17   Service of orders
• § 814.19   Product development protocol (PDP)

Subpart B - Premarket Approval Application (PMA)

• § 814.20   Application
• § 814.37   PMA amendments and resubmitted PMAs
• § 814.39   PMA supplements

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

Subpart E - Postapproval Requirements

• § 814.80   General
• § 814.82   Postapproval requirements
• § 814.84   Reports

Subpart H - Humanitarian Use Devices

• § 814.100   Purpose and scope
• § 814.102   Designation of HUD status
• § 814.104   Original applications
• § 814.106   HDE amendments and resubmitted HDE's
• § 814.108   Supplemental applications
• § 814.110   New indications for use
• § 814.112   Filing an HDE
• § 814.114   Timeframes for reviewing an HDE
• § 814.116   Procedures for review of an HDE
• § 814.118   Denial of approval or withdrawal of approval of an HDE
• § 814.120   Temporary suspension of approval of an HDE
• § 814.122   Confidentiality of data and information
• § 814.124   Institutional Review Board requirements
• § 814.126   Postapproval requirements and reports