Regulatory Resources
Clinical guidelines, MDCG guidance, FDA guidance, standards, and compliance tools
21 CFR Part 801 — Device Labeling
Covers all labeling requirements for medical devices including labels affixed to the device and all descriptive and informational literature that accompanies it.
Download PDF21 CFR Part 803 — Medical Device Reporting (MDR)
Mandatory reporting for incidents where a device may have caused or contributed to death or serious injury. Applies to manufacturers, importers, and device user facilities.
Download PDF21 CFR Part 807 Subpart E — Premarket Notification 510(k)
Requires a 510(k) submission before commercial distribution of a device, demonstrating substantial equivalence to a legally marketed predicate device.
Download PDF21 CFR Part 814 — Premarket Approval (PMA)
Governs the most stringent FDA device pathway, required for Class III high-risk devices. Requires valid scientific evidence of safety and effectiveness, including clinical data.
Download PDF21 CFR Part 812 — Investigational Device Exemption (IDE)
Allows investigational devices to be used in clinical studies to collect safety and effectiveness data in support of a PMA or 510(k) submission.
Download PDF21 CFR Part 820 — Quality Management System Regulation (QMSR)
Governs methods, facilities and controls used in design, manufacture, packaging, labelling and servicing of finished devices. Effective February 2026, incorporates ISO 13485:2016 by reference.
Download PDFFD&C Act — Federal Food, Drug, and Cosmetic Act
The foundational US law authorizing FDA to regulate medical devices. Sections 513–520 govern device classification, premarket review, postmarket requirements, and enforcement.
Download PDF21 CFR Part 807 — Establishment Registration and Device Listing
Requires domestic and foreign manufacturers to register with FDA and list their devices annually. Foreign manufacturers must designate a US Agent.
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