Types of FDA Regulations for Medical Devices in USA

These are the basic regulations that US-based medical device manufacturers and distributors must comply with and understand them one by one.

• Establishment Registration & Medical Device Listing – 21 CFR Part 807
• Pre-market Notification 510(k) – 21 CFR Part 807 Subpart E
• Pre-market Approval (PMA) – 21 CFR Part 814
• Investigational Device Exemption (IDE) for clinical studies – 21CFR Part 812
• Quality System (QS) regulation 21 CFR Part 820
• Labeling requirements – 21 CFR Part 801
• Medical Device Reporting (MDR) – 21 CFR Part 803

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