FDA medical device classification and the 3 device classes
FDA medical device classification sorts devices into Class I, II or III by risk. What each class needs, real examples and how to find your device's class.
FDA medical device classification uses three classes based on the controls needed to give reasonable assurance of safety and effectiveness. Class I is the lowest risk and needs general controls, Class II adds special controls and usually a 510(k), and Class III is the highest risk and generally needs premarket approval (PMA) (FDA).
Start with the classification regulation for your generic device type. FDA has classified about 1,700 types across 16 medical specialty panels (FDA). Find the matching three-letter product code in the Product Classification Database. Check intended use and technology, not just the device name.
The 3 classes of medical devices
The legal test sits in section 513(a)(1) of the FD&C Act (21 USC 360c). A device is Class I when general controls are enough. It is Class II when general controls alone are not enough but there is enough information to set special controls. Class III is for devices that can't go in Class I or II and that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.
| Class | Risk | Controls | Usual premarket route |
|---|---|---|---|
| Class I | Lowest | General controls | Mostly 510(k) exempt (about 74% of types); otherwise 510(k) |
| Class II | Higher than Class I | General and special controls | 510(k), unless exempt |
| Class III | Highest | General controls and PMA | PMA |
General and special controls
"General controls apply to all medical devices, unless exempted by regulations," says FDA's page on regulatory controls. They cover adulteration, misbranding, establishment registration and device listing, banned devices, notification and repair, replace or refund, records and reports, and general provisions such as good manufacturing practice.
Special controls are the extra layer for Class II. FDA lists performance standards, postmarket surveillance, patient registries, special labeling, premarket data requirements and guidelines as examples (FDA).
Which premarket submission each class needs
A Class I or II device that is not exempt needs a 510(k) before marketing. Class III devices generally need a PMA, though pre-amendment Class III devices may not need one until FDA calls for PMAs by regulation (FDA).
About 572 Class I device types, or 74% of Class I, are exempt from 510(k) (FDA). FDA says "most class I and some class II devices are exempt from 510(k) requirements" but gives no Class II percentage (FDA). Those exemptions have limits, in sections such as 21 CFR 880.9 and 878.9.
Class I, II and III medical device examples
These examples link each device type to its classification regulation. Class 1 medical devices are not always exempt from 510(k): examination gloves are one exception. For exempt types, check the exemption limits before relying on them (FDA).
| Class | Device | Regulation |
|---|---|---|
| Class I, 510(k) exempt | Tongue depressor | 21 CFR 880.6230 |
| Class I, 510(k) exempt | Elastic bandage | 21 CFR 880.5075 |
| Class I, 510(k) exempt | Manual surgical instrument for general use | 21 CFR 878.4800 |
| Class I, 510(k) required | Non-powdered patient examination glove | 21 CFR 880.6250 |
| Class II | Infusion pump | 21 CFR 880.5725 |
| Class II | Powered wheelchair | 21 CFR 890.3860 |
| Class II | Condom | 21 CFR 884.5300 |
| Class II | Oximeter | 21 CFR 870.2700 |
| Class III | Replacement heart valve | 21 CFR 870.3925 |
| Class III | Implantable pacemaker pulse generator | 21 CFR 870.3610 |
| Class III | Silicone gel-filled breast prosthesis | 21 CFR 878.3540 |
| Class III | Intraocular lens | 21 CFR 886.3600 |
Class III medical device examples lean towards implants, but not all of them are. A high-energy DC defibrillator (product code DRK, 21 CFR 870.5300) is Class III, needs a PMA and isn't implanted.
How FDA assigns a device to a class and panel
Panels and classification regulations
Classification regulations use a seven-digit number, such as 21 CFR 880.2920 for the clinical mercury thermometer, FDA's worked example (FDA). The regulations sit in 16 parts of Title 21, Subchapter H, one per panel (FDA panel list):
| CFR part | Panel |
|---|---|
| 862 | Clinical Chemistry and Clinical Toxicology |
| 864 | Hematology and Pathology |
| 866 | Immunology and Microbiology |
| 868 | Anesthesiology |
| 870 | Cardiovascular |
| 872 | Dental |
| 874 | Ear, Nose, and Throat |
| 876 | Gastroenterology-Urology |
| 878 | General and Plastic Surgery |
| 880 | General Hospital and Personal Use |
| 882 | Neurological |
| 884 | Obstetrical and Gynecological |
| 886 | Ophthalmic |
| 888 | Orthopedic |
| 890 | Physical Medicine |
| 892 | Radiology |
Finding the FDA device classification
FDA says to search the Product Classification Database with part of the device name, or to open the panel's CFR part if you already know it. You can search by device name, product code, review panel, regulation number, submission type, device class and flags such as implanted or life-sustaining. Each record shows the product code, class, regulation number, submission type (such as 510(k), 510(K) Exempt, PMA or Enforcement Discretion), review panel, GMP exemption, third-party review eligibility and recognized consensus standards. The record for LYZ, the vinyl patient examination glove, shows Class 1, 510(k), General Hospital panel.
If you still can't place the device, you can file a 513(g) request for information. Within 60 days of that written request, FDA must send a written statement of the classification, if any, and the requirements that apply (21 USC 360c(g)). Check the current FDA user fee before filing.
Novel devices and De Novo
A device that was not marketed before May 28, 1976 starts in Class III under section 513(f)(1). It stays there until FDA reclassifies it, finds it substantially equivalent to a predicate through a 510(k), or classifies it through De Novo (21 USC 360c).
De Novo is FDA's "risk-based classification process" for novel devices with no legally marketed predicate, where general controls, or general and special controls, are enough (FDA). The device goes into Class I or II, FDA creates a new classification regulation, and the device can then serve as a predicate for later 510(k)s.
Classes change
FDA reclassifies pre-amendments devices under section 513(e) by administrative order, with a proposed order, a panel meeting and public comment. Post-amendments devices are reclassified under 513(f)(3) (FDA). For example, non-invasive bone growth stimulators moved from Class III to Class II, effective May 18, 2026 (Federal Register). Check the current record, not a list you saved last year.
Common classification mistakes
Class is not the same as submission type. Patient examination gloves are Class I, yet under 21 CFR 880.6250 only finger cots are exempt, so most exam gloves still need a 510(k).
A search by device name alone can give the wrong result. Oximeters show why. The standard oximeter, DQA, is Class 2 with a 510(k). An infrared oximeter for sporting or aviation use only, OCH, sits under the same regulation but falls under enforcement discretion. A fetal pulse oximeter, MMA, is Class 3 and needs a PMA. Condoms work the same way: HIS is Class 2 under 884.5300, while the glans sheath, LZL, is Class 3 under 884.5320.
The review panel and CFR part can differ. DQA's record lists Part 870 (Cardiovascular) but an Anesthesiology review panel. Some records, including MMA, have no regulation number. Check the class in the product code record rather than assuming a blank field means the device is unclassified.
RegAffairs AI's answer on FDA medical device classification links to the stored FDA records behind its examples.