In the chart above, Subchapter H (Parts 800–898), highlighted in the pink box, covers medical devices. Each Part has specific content, as shown in the table below:
Below we explain in detail the content of Part 807, highlighted in the pink box in the table above, in one chart:
For the other Parts in Subchapter H (Parts 800–898) listed in the table, you can use the same method to find and view the content and requirements of the US federal regulations.
1. Distribution and characteristics of the core Parts
1. Drugs:
Parts 200–499: divided into general requirements (Parts 200–299) and human drugs (Parts 300–499). For example, Parts 210–211 are the drug CGMP regulations, and Part 314 sets out the New Drug Application (NDA) process.
2. Medical devices:
Parts 800–898: including the quality management system (Part 820), premarket notification (Part 807) and adverse event reporting (Part 803). For example, Part 800.10 sets sterility requirements for contact lens solutions.
3. Biologics:
Parts 600–680: licensing and manufacturing standards for vaccines, blood products, etc. For example, Part 601 requires biologics to obtain a Biologics License Application (BLA) before marketing.
4. Cosmetics:
Parts 700–799: including cosmetic labelling (Part 701) and warning statements (Part 740). Cosmetics do not require FDA pre-market approval, but since the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), companies must register their facilities and list their products.
5. Radiation-emitting products:
Parts 1000–1050: performance standards and safety requirements for X-ray equipment, laser products, etc. For example, Part 1020 requires radiation-emitting equipment to meet radiation protection standards.
2. Practical validity and updating of Parts
1. Reserved and unused Parts:
Some Part numbers are marked “[Reserved]” in the regulations and kept for future regulatory expansion.
As regulations are revised, some old Parts may be merged or repealed. For example, in February 2024 the FDA published the Quality Management System Regulation (QMSR) final rule, which amends Part 820 and incorporates ISO 13485:2016 by reference, effective 2 February 2026.
2. Dynamic updating:
The FDA publishes regulatory revisions and new rules in the Federal Register, and companies should keep track of changes relevant to their products.
Companies should regularly check the eCFR website (https://www.ecfr.gov) for the latest version.
3. How to quickly locate key Parts
1. By topic:
Food contact materials: Parts 175–178 (plastics, coatings, etc.).
Medical device registration: Part 807 (establishment registration) and Part 812 (investigational device exemptions).
Electronic records: Part 11 (electronic signatures and records requirements).
2. Using FDA resources:
Regulatory navigation tools: the FDA website allows searching by keyword or number to quickly locate the content of a Part.
Industry guidance: for example, the FDA’s UDI guidance documents explain in detail how Parts 801 and 830 apply.
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