Parts 862–892 — Device-Specific Regulations
21 CFR Parts 862–892 contain the specific classification regulations for all medical device types regulated by FDA. Each part covers devices within a specific medical specialty panel.
The 16 device panels
| 21 CFR Part | Panel / Specialty | Examples |
|---|---|---|
| 862 | Clinical chemistry & toxicology | Glucose meters, drug testing kits, clinical analysers |
| 864 | Hematology & pathology | Blood cell counters, coagulation analysers, slide stainers |
| 866 | Immunology & microbiology | HIV tests, COVID-19 antigen tests, bacterial ID systems |
| 868 | Anesthesiology | Ventilators, pulse oximeters, anaesthesia machines |
| 870 | Cardiovascular | Pacemakers, stents, AEDs, cardiac monitors |
| 872 | Dental | Dental drills, X-ray units, implants, materials |
| 874 | ENT | Hearing aids, cochlear implants, ENT scopes |
| 876 | Gastroenterology & urology | Endoscopes, urological catheters, colonoscopes |
| 878 | General & plastic surgery | Sutures, surgical mesh, wound dressings |
| 880 | General hospital & personal use | Hospital beds, infusion pumps, patient monitoring |
| 882 | Neurology | Deep brain stimulators, EEG systems, neurovascular devices |
| 884 | Obstetrics & gynaecology | Foetal monitors, IUDs, forceps |
| 886 | Ophthalmic | Intraocular lenses, laser systems, contact lens products |
| 888 | Orthopaedic | Total joint replacements, bone screws, spinal implants |
| 890 | Physical medicine | Powered wheelchairs, prosthetics, TENS units |
| 892 | Radiology | MRI systems, X-ray, CT scanners, PACS software |
Structure of each part
Each 21 CFR Part from 862–892 follows the same structure:
- Subpart A — General provisions
- Subpart B — Class II devices (most common)
- Subpart C — Class III devices
- Specific sections — Each section covers a specific device type with:
- Device identification and intended use
- Classification (Class I, II, or III)
- Any applicable performance standards
- 510(k) exemption status and limitations
How to use the classification regulations
- Identify the most applicable device type in FDA's Product Classification Database
- Note the product code and the associated 21 CFR Part and section number
- Navigate directly to that section in eCFR for the full classification regulation
- Check for any 510(k) exemption conditions or limitations in the regulation text