FDA Medical Device Classification
How does the FDA classify medical devices?
The FDA sorts medical devices into three classes by risk: Class I is the lowest risk and Class III the highest (FDA, Classify Your Medical Device). The class sets which regulatory controls apply. It also usually sets the premarket route: 510(k) exempt, 510(k), or PMA.
The three classes (21 CFR 860.3) (eCFR 21 CFR 860.3)
| Class | Legal definition | Controls | Usual premarket route |
|---|---|---|---|
| I | Devices "subject only to the general controls" of FD&C Act sections 501, 502, 510, 516, 518, 519 and 520 | General controls | Mostly exempt. FDA says about 572 Class I devices (74%) don't need premarket notification |
| II | Devices that are "or eventually will be subject to special controls" | General controls plus special controls | 510(k), unless exempt |
| III | Devices for which "premarket approval is or will be required in accordance with section 515" | General controls plus premarket approval | PMA |
- General controls apply to every device in every class. They cover adulteration, misbranding, registration, banned devices, notification and remedies, records and reports, and general provisions (FDA, Regulatory Controls).
- Special controls are for Class II devices. FDA's examples are performance standards, postmarket surveillance, patient registries, special labelling, premarket data requirements and guidelines (same page).
- Class III covers devices that are "intended to be used in supporting or sustaining human life", or where general and special controls are not enough to assure safety and effectiveness (same page).
- Pre-amendment Class III devices may not need a PMA until FDA has called for one (FDA, Classify Your Medical Device).
How a device gets its class
- About 1,700 generic device types are grouped into 16 medical-specialty panels, codified in 21 CFR Parts 862-892. Each type has a 7-digit regulation number, for example 21 CFR 880.2920 (FDA, Classify Your Medical Device).
- The day-to-day lookup is the Product Classification Database. Each three-letter product code links to the device class, regulation number, review panel and submission type.
- If you need FDA's formal view on a device's class, you can file a 513(g) request. User fees apply (same FDA page).
- De Novo is for novel devices that have no legally marketed predicate. It covers devices where general controls, or general and special controls, give reasonable assurance of safety and effectiveness. The result is classification into Class I or II instead of the automatic Class III (FDA, De Novo Classification Request).
Examples from the Product Classification Database
- Non-surgical tongue depressor (FMA): Class 1, 21 CFR 880.6230, 510(k) exempt, General Hospital panel [1]
- Condom (HIS): Class 2, 884.5300, 510(k), eligible for third-party review [2]
- External transcutaneous cardiac pacemaker (DRO): Class 2, 870.5550, 510(k), flagged life-sustaining/supporting [3]
- Implantable pacemaker pulse generator (DXY): Class 3, 870.3610, PMA, implant [4]
- High-energy DC defibrillator (DRK): Class 3, 870.5300, PMA. The record notes "PMA to be filed by 12/26/96", which is a PMA call for a pre-amendment device [5]
Class can also turn on product code and intended use, not just the device name. A standard condom is Class 2 under 510(k), while a "micro-condom" (glans sheath, 884.5320) is Class 3 under PMA [6].
Approach: I used FDA's Product Classification Database (CDRH) for the examples and took the class definitions from 21 CFR 860.3 on eCFR. The explanations of controls, panels and De Novo come from FDA's own guidance pages.
If you tell me the device and its intended use, I can find the matching product code, class, regulation number and submission type.
What are some examples of Class III devices?
Class III devices are mostly implants and devices that sustain life or carry high risk. Typical examples are replacement heart valves, coronary stents, implantable pacemakers, breast implants, intraocular lenses, deep brain stimulators and implanted infusion pumps. Every one of the examples below is listed as Class 3 in FDA's Product Classification Database.
Cardiovascular
| Product code | Device | 21 CFR | Implant |
|---|---|---|---|
| DYE | Replacement heart valve | 870.3925 | Y [7] |
| LOZ | Artificial heart | none listed | Y [8] |
| OKR | Ventricular bypass (assist) device | 870.3545 | N [9] |
| MAF | Coronary stent | none listed | Y [10] |
| MCX | Coronary atherectomy catheter | none listed | N [11] |
| DXY | Implantable pacemaker pulse generator | 870.3610 | Y [4] |
| NVN | Drug-eluting permanent RV/RA pacemaker electrodes (flagged life-sustaining/supporting) | none listed | Y [12] |
| DRK | High-energy DC defibrillator, including paddles | 870.5300 | N [5] |
Neurology
| Code | Device | 21 CFR | Implant |
|---|---|---|---|
| GYZ | Implanted intracerebral/subcortical stimulator | 882.5840 | Y [13] |
| DSR | Carotid sinus nerve stimulator | 870.3850 | Y [14] |
| LKW | Neurosurgical laser | none listed | N [15] |
Ophthalmic
| Code | Device | 21 CFR | Implant |
|---|---|---|---|
| HQL | Intraocular lens | 886.3600 | Y [16] |
| MFK | Multifocal intraocular lens | 886.3600 | Y [17] |
| LQE | Refractive corneal implant | none listed | Y [18] |
| LWL | Intraocular fluid | 886.4275 | N [19] |
Plastic surgery and aesthetics
| Code | Device | 21 CFR | Implant |
|---|---|---|---|
| FTR | Silicone gel-filled breast prosthesis | 878.3540 | Y [20] |
| FWM | Saline inflatable breast prosthesis | 878.3530 | Y [21] |
| LMH | Dermal implant for aesthetic use | none listed | Y [22] |
| KGM | Injectable liquid silicone | none listed | N [23] |
Orthopaedic and spine
| Code | Device | 21 CFR | Implant |
|---|---|---|---|
| MJO | Intervertebral disc prosthesis | none listed | Y [24] |
| MPW | rhBMP bone filler on a collagen scaffold (osteoinductive) | none listed | Y [25] |
Urology, gynaecology and drug delivery
| Code | Device | 21 CFR | Implant |
|---|---|---|---|
| EZW | Implantable electrical stimulator for incontinence | 876.5270 | Y [26] |
| FAG | Urethral sphincter prosthesis | none listed | Y [27] |
| HDO | Tubal occlusion valve | 884.5380 | Y [28] |
| LKK | Implanted programmable infusion pump | none listed | Y [29] |
| MQT | Closed-loop drug administration pump | none listed | N [30] |
| OYC | Insulin infusion pump used with an invasive glucose sensor | none listed | N [31] |
Many of these records give no 21 CFR regulation number. Their class comes from the product code record, not from a codified classification regulation.
Some patterns are worth knowing:
- Not every Class III device is an implant. The defibrillator, atherectomy catheter, neurosurgical laser and closed-loop pump are all non-implant Class III devices.
- The product-code flags don't always match intuition. For example, the artificial heart record (LOZ) is not flagged life-sustaining/supporting [8].
Approach: I searched FDA's CDRH Product Classification Database for device types listed as Class 3, across cardiovascular, neurology, ophthalmic, surgical, orthopaedic, urology and drug-delivery categories. This is a selection of examples, not every Class III product code.
How do I find which class my device is in?
You find your device's class by matching it to an FDA product code in the Product Classification Database. Each product code carries the class, the 21 CFR regulation number and the premarket submission type. The match depends on your device's intended use and technology, not just its name, so a search on one device name usually turns up several codes, and they can sit in different classes.
Step by step
- Write down your intended use and how the device works. Note the indication, target anatomy, patient population, how it's used (invasive or not, implanted or not) and the technology. These details decide which product code fits.
- Search the Product Classification Database by device name or keyword. Then read each candidate record's definition, regulation description and review panel. A search on "oximeter" shows why this step matters:
| Code | Device | Class | 21 CFR | Submission type |
|---|---|---|---|---|
| DQA | Oximeter | 2 | 870.2700 | 510(k) [32] |
| DPZ | Ear oximeter | 2 | 870.2710 | 510(k) [33] |
| MUD | Tissue saturation oximeter | 2 | 870.2700 | 510(k) [34] |
| DQE | Fiber-optic oximeter catheter | 2 | 870.1230 | 510(k) [35] |
| GLY | Oximeter to measure hemoglobin | 2 | 864.7500 | 510(k), Hematology panel [36] |
| NLF | Reprocessed oximeter | 2 | 870.2700 | 510(k). Reprocessing validation data must be included [37] |
| OCH | Infrared oximeter for sporting/aviation use only | 2 | 870.2700 | Enforcement discretion [38] |
| MMA | Fetal pulse oximeter | 3 | none listed | PMA [39] |
These are all "oximeters", yet a fetal pulse oximeter is Class 3 under PMA while a standard oximeter is Class 2 under 510(k). A sports watch used only for sporting and aviation activities falls under enforcement discretion. Intended use is what separates them. 3. Confirm against the classification regulation. Where the record gives a 21 CFR number, read that section and check that your device fits its identification. Some regulations also list Class I/II splits or exemption limits. 4. Read the rest of the record. Look at the 510(k)-exempt, GMP-exempt and third-party review flags, the implant and life-sustaining flags, the recognized consensus standards and any linked guidance. For example, the DQA record lists ISO 80601-2-61 and FDA's pulse oximeter 510(k) guidance [32]. 5. Check predicates. Search 510(k) clearances under the product code you picked to confirm that similar devices were cleared under it. 6. If nothing fits or it's unclear:
- 513(g) request: asks FDA for its formal view on your device's classification and regulatory requirements (user fee applies).
- De Novo: for a novel device with no predicate that would otherwise default to Class III, where general and/or special controls are enough. This is the route to Class I or II.
- Combination products (drug/biologic plus device) may need a lead-center assignment before you can classify the device part.
Approach: I searched FDA's CDRH Product Classification Database and the De Novo register using oximeters as a worked example. No oximeter De Novo records turned up. The 513(g) and De Novo routes are described as FDA's own pages set them out (cited in my first answer).
If you tell me your device's intended use and technology, I can shortlist the matching product codes, give you the class, regulation and submission type for each, and look for De Novo or 510(k) precedents.