How is My Medical Device Classified?

Slide 1 

Hello, my name is Commander Kimberly Piermatteo of the United States Public Health Service and I am 

a Consumer Safety Officer within the Center for Devices and Radiological Health’s Division of Industry 

and Consumer Education at FDA. Welcome to CDRH learn, CDRH’s resource for multimedia industry 

education. This CDRH Learn module addresses the question “how is my medical device classified?” Once 

you determine that your product would be regulated as a medical device the next step is to determine 

how your medical device is classified and what regulatory requirements apply to your device. 

Slide 2

After watching this module, I hope you will gain a better understanding of how to classify your medical 

device and identify the applicable regulatory requirements for your device. I also encourage you to 

watch the companion CDRH Learn module which walks through a case study on how to classify a 

medical device using the various methods discussed in this module. 

Slide 3

I will address the following four learning objectives during this module. First, I’ll discuss how the FDA 

classifies medical devices. Next, I’ll discuss the different regulatory requirements for medical devices 

based on their class. Then I’ll briefly go over different classifications methods you may use to help you 

determine the class of your medical device. And, lastly, I’ll identify ways for you to request additional 

assistance if needed. 

Slide 4

Let’s first review the different medical device classes and the regulatory requirements that apply to each 

class. 

Slide 5

The FDA regulates medical devices based on risk, that is, the risk the device poses to the patient and/or 

user. The risk is a major factor in determining which class it is assigned. Subsequently, the class of the 

device then determines the extent of regulatory controls that are necessary to provide reasonable 

assurance of a device’s safety and effectiveness. 

Slide 6 

The FDA classifies all medical devices into one of three regulatory classes. Medical devices may be 

classified as class I, class II or class III. As I discuss each class of medical devices, I will fill in the middle 

columns of this table looking at the columns titled device risk and potential harm, as well as applicable 

regulatory controls and submission types or exemption for each device class.

Slide 7

The risk of the device determines whether the device will be considered Class I, II or III. Within the table 

provided on this slide, I have filled in the risk and potential harm columns for each device class. Class I 

devices are considered to be the lowest risk and present minimal potential for harm to the patient or 

user. Class II devices are considered moderate risk and present a higher risk than class one devices. Class 

III devices are considered the highest risk devices and these devices may sustain or support life, be 

implanted or present the potential for unreasonable risk of illness or injury.

Slide 8 
Next in the table I’m going to discuss regulatory controls. However, I’d like to define what regulatory 

controls are first before I fill in the table.

Slide 9 

Regulatory controls are referred to as either general, special or premarket approval controls. They may 

apply to a particular device type and are generally broad, but they may be device specific. Regulatory 

controls describe the appropriate level of regulatory oversight necessary to ensure reasonable 

assurance of a device’s safety and effectiveness. More information on regulatory controls can be found 

on the link provided at the bottom of this slide. 

Slide 10 

Referring back to the classes of medical devices table, regulatory control increases from Class I to Class 

III. Devices in all three classes are subject to general controls, unless exempted by the regulations. In 

addition to complying with general controls, Class II devices may also be subject to special controls. Class 

III devices must comply with general controls as well as Premarket Approval controls. 

Slide 11

This slide provides examples of some general controls, which apply to all medical device classes. A few 

examples of general controls from the table provided on this slide include requirements for companies 

to register their establishments and list the medical devices they market with the FDA; as well as the 

requirement to manufacture their devices in accordance with Good Manufacturing Practices; and the 

requirement to label their devices in accordance with the FDA’s labeling regulations. If a device is 

exempted from a specific general control, such an exemption would be stated in the classification 

regulation for that particular device.

Slide 12

Class II devices may also be subject to special controls, which would be identified by the FDA and may 

include special labeling requirements, or design characteristics or specifications, or compliance with a 

particular performance standard or testing. There may also be a Special Controls guidance document for 

a particular device type outlining any of these. 

Slide 13 

Class III devices are typically life supporting or life sustaining, therefore, due to the level of risk 

associated with Class III devices, general and special controls alone are insufficient to assure the safety 

and effectiveness of Class III devices. These devices must obtain Premarket Approval prior to marketing. 

A Premarket Approval Application, or a PMA, is the most stringent type of device marketing application. 

PMA requirements are outlined within the code of federal regulations or CFR, under section 814 

specifically. Examples of Class III devices that require PMA are intraocular lenses and mechanical heart 

valves. 

Slide 14 

The next column in the classes of medical devices table discusses the applicable submission type for 

each class or if there is not an applicable submission type, whether there may be an exemption. Most 

Class I devices are exempt from the Premarket Notification or 510(k) requirements. Most Class II devices 

require Premarket Notification or 510(k) clearance prior to marketing. There are some Class II devices 

which are 510(k) exempt, as long as the device complies with FDA defined special controls. And lastly, 

Class III devices require Premarket Approval prior to marketing. For more information on exemptions 

and any limitations to those exemptions, you may refer to the webpage titled, Class I and II exemptions. 
A link to this webpage is provided at the end of this module on the resources slides. Links to the FDA’s 

webpages on 510(k) and PMA are also provided on the resources slides at the end of this module.

Slide 15 

When I discuss the device class and the extent of regulatory requirements, I think it is important to 

mention FDA product codes. FDA product codes are three letter codes used to identify and track similar 

devices. If you are able to determine the appropriate FDA product code for your device, you can then 

easily determine the applicable regulatory requirements. Product codes can be found by searching the 

FDA’s public product classification database. On this slide, I’ve provided a screen shot of this database as 

well as a link to this database. 

Slide 16

Another point I’d like to make is within the CFR, the FDA has classified various device types based on 

risk. Each regulation number may have one or more associated product codes which are classified 

differently and have different regulatory requirements. For example, the regulation number 21 CFR 

870.1875 has four different product codes under this one regulation number. As displayed in the table, a 

manual stethoscope is considered to be Class I and 510(k) exempt under the product code LDE, whereas 

an electronic stethoscope, which falls under the same regulation number, has a different product code, 

is considered Class II and is not 510(k) exempt. The point to remember here is that when classifying a 

medical device, it is very important to drill down all the way to the appropriate FDA product code, and 

not just to the class or regulation number. Determining the appropriate product code will help you 

determine the extent of regulatory requirements for your device.

Slide 17 

To complete the classes of medical devices table, the last column provides you some insight into the 

percentage of devices in each class. Out of all the regulated medical devices, roughly 35% are considered 

to be Class I, 53% are considered Class II and 9% are considered Class III. As noted by the asterisk, 

roughly 3% of devices are unclassified. An unclassified device is a device which was in commercial 

distribution, prior to the medical device amendments of 1976, and for which has not yet been classified 

into Class I, II or III.

Slide 18

Next, I’m going to discuss three classification determination methods. These methods are not the only 

methods available to you, but ones which I find helpful when determining how a medical device may be 

classified. During this module I will briefly discuss these methods. I encourage you to watch the 

companion CDRH Learn module within which I cover each of these methods in more details using a 

specific case study. 

Slide 19

The three methods I find useful when determining the classification of a medical device are: one, to 

directly search for the appropriate product classification; two, to search for a similar device by its 

clearance or approval; and third, to search for a similar device by device listing. 

Slide 20

The first method I recommend is to search directly for an appropriate product classification in the FDA’s 

public Product Classification database. A link to this database is provided on this slide. You can search 

this database to identify an appropriate FDA product code which then based on the product code you 
can review the regulatory requirements for that particular device type. This method is the most 

common and often used.

Slide 21

The second method is useful if you know of a similar device already being marketed. You can work 

backwards by determining how the similar device has been classified based on its 510(k) clearance or 

PMA approval and then determine if the same classification applies to your proposed device. For this 

method you would only be able to search for devices which received 510(k) clearance or Premarket 

approval. Since most Class I devices and some Class II devices are exempt from 510(k) clearance and do 

not require PMA approval, you would not be able to find these devices and determine how they are 

classified using this method. 

One note I’d like to make is - if a device has been classified but it did not receive 510(k) clearance or 

PMA approval, it may have obtained marketing authorization through a De Novo. The De Novo pathway 

provides a possible route to classify novel devices of low to moderate risk. If you think a similar device 

was the first new, novel device type, then this first marketing authorization would not be found in the 

510(k) clearance database. You would need to search the De Novo database to find this first classified 

device under the newly created regulation. Links to all three public databases have been provided on 

this slide and on the resources slides at the end of this module. 

Slide 22

The third method I recommend is to search for a similar device by device listing. This method is useful 

when determining how a currently marketed device is classified because establishment registration and 

device listing are a general control, meaning all medical device establishments currently marketing a 

device in the United States must be registered with FDA and list their devices. 

So, if you know of a similar device currently being marketed you can search for it by its listing and see if 

the same product classification applies to your device. A link to the FDA’s public Establishment 

Registration and Device Listing database is provided on this slide. 

Slide 23

If you are unable to determine the appropriate product classification for your proposed device, you may 

consider requesting additional assistance from the FDA.

Slide 24 

For informal assistance, you may contact the Division of Industry and Consumer Education or DICE. DICE 

staff can provide further guidance on conducting any of the three search methods discussed in this 

module. DICE staff may be reached at the phone number or email provided on this slide. Please note, 

responses to such informal assistance are not classification decisions and do not constitute FDA 

clearance or approval for commercial distribution. 

Slide 25 

If you would like to request a formal product classification from the FDA, you should consider submitting 

a 513(g) Request. Section 513(g) of the Federal Food, Drug and Cosmetic Act, or the FD&C Act, provides 

a means for obtaining the agency's views about the product classification and regulatory requirements 

that may be applicable to a particular device.
For instructions on how to submit a 513(g) Request, refer to the FDA guidance document titled FDA and 

Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug and 

Cosmetic Act. A link to this guidance is provided on this slide.

Keep in mind a response to a 513(g) Request does not constitute FDA clearance or approval for 

commercial distribution, meaning if FDA’s response to a 513(g) Request states a 510(k) clearance for the 

described device is required, a 510(k) clearance must be obtained prior to marketing.

Slide 26 

In summary, medical devices are classified based on risk, and the risk of the device determines the 

extent of regulatory controls. When determining the applicable class and regulatory requirements for a 

device, searching the FDA public databases can be helpful. 

Slide 27

Additional resources and links are provided on the... 

Slide 28

next few slides. I will not cover them in detail...

Slide 29

but they are provided for your reference as needed.

Slide 30

CDRH provides multiple opportunities for industry education. On this slide, I have provided you links to 

CDRH Learn which consists of numerous learning modules covering a wide range of medical device 

topics; as well as Device Advice, which is a text-based resource and lastly, you may contact the Division 

of Industry and Consumer Education or DICE by phone or email with questions. 

Slide 31

For this module, my call to action for you is, to evaluate the risk of your device to determine the 

appropriate class and regulatory controls necessary to ensure its safety and effectiveness. As well as 

become familiar with the three methods for determining classification which can be instrumental when 

determining how your medical device may be classified. If you would like more details on the three 

methods discussed, be sure to watch the companion CDRH Learn module titled, Case Study - How is My 

Medical Device Classified. 

Thank you for watching and I hope you found this module to be useful.

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