Regulations that describe the basic content requirements by submission type include:
• Investigational Device Exemption (IDE) – 21 CFR 812.20
• Premarket Notification (510(k)) – 21 CFR 807.87
• Premarket Approval (PMA) – 21 CFR 814.20
• Humanitarian Device Exemption (HDE) – 21 CFR 814.104.
