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 CDRH Industry Basics: 513(g) Requests for Information 

Slide 1 

Good afternoon, my name is Ifeanyi Uwemedimo and I am a device determination 

policy analyst in the Office of Regulatory Programs in CDRH. I am currently responsible 

for the device determination mailbox. Welcome to this presentation on 513(g) Requests 

for Information.

Slide 2 

You have a product and you’re not sure whether the product is a medical device and, if 

yes, how FDA classifies it. What do you do? The purpose of this presentation is to 

provide information on how FDA addresses device determination and classification 

inquiries.

Slide 3

During this presentation, I will describe how FDA addresses device determination 

inquiries. I will outline the 513(g) request process, and address when it is best to send 

an informal inquiry to the device determination mailbox, or submit a formal 513(g) 

request for information.

Slide 4

Before we delve into how a device determination is made or what a 513(g) is, it’s 

important to first understand how FDA defines medical device. So, what is a medical 

device? The complete definition of a medical device is provided in Section 201(h) of the 

Food Drug and Cosmetic Act, also known as the FD&C Act. 

Slide 5

Without reading the full definition, in summary, a medical device is a device that is 

intended to be used for a medical purpose and can affect the structure or function of the 

body. In other words, the device can be used to diagnose a disease or condition. It 

could also be used to cure, mitigate, treat or prevent a disease or condition.

Slide 6

The first bullet on this slide is typically what distinguishes a medical device from a drug. 

It is important to note that a medical device does not achieve its primary intended 

purpose through chemical action. In other words, it does not require a chemical to be 

metabolized or processed in the body to impart the intended use. If a chemical action is 

required, the product is most often a drug and not a device. The term "device" generally 

does not include the software functions excluded under section 520(o).
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Slide 7

It’s important to note that medical devices are also classified based on the level of risk. 

Low risk devices are classified as Class I, Moderate risk devices are Class II, and High

risk devices are regulated as Class III devices. The risk level or class also helps to 

determine the type of premarket submission such as 510(k) or PMA that’s required to 

determine device safety and effectiveness

Slide 8

Class III devices require submission of a Premarket Approval Application, also known 

as PMA. PMAs are the most stringent pre-market submission and typically require 

clinical data. Most Class II devices require Premarket Notification or 510(k) submissions 

and these typically do not require clinical data. Less than 15% of 510(k) submissions 

received annually require clinical data. Lastly, the majority of Class I devices do not 

require a 510(k). However, there is a very small percentage that do require a 510(k).

Slide 9 

The De Novo classification pathway was established in 1997. While it’s not mentioned 

in the pyramid on the previous slide, the De Novo pathway is an alternative pathway 

intended for novel low to moderate risk devices. When we say that a device is novel, it

means that FDA has never seen or regulated a similar device. It’s important to note that 

novel medical devices are automatically placed into Class III.

Slide 10 

There are a number of different medical device categories. I won’t go through each one 

in detail. Device categories may include diagnostic devices, such as blood glucose 

monitors, and therapeutic devices, such as CPAP devices. We also have a category of 

devices known as general wellness products. These products are low risk devices 

intended to promote the general wellness of a patient. As technology continues to 

advance, these categories will continue to expand. We also included Mobile medical 

applications, also known as MMAs, that meet the definition of a medical device. For 

example, there are MMAs that can be used to monitor heart conditions.

Slide 11 

Now, that you understand how FDA defines a medical device and the different 

classifications, you are now in a better position to determine whether your product is a 

medical device.

Slide 12

This slide shows the steps that can be taken to further address your device 

determination inquiry. To determine if a product is a medical device, it’s important to 

understand the technology and intended use of the device. 

The next step is to determine whether it meets FDA’s definition of a medical device. In 

other words, is it intended to treat, diagnose, cure or mitigate a disease or condition? 
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When FDA makes a device determination, we use our existing databases, such as the 

product code, 510(k) and De Novo database to look for similar devices and existing 

regulations. These databases are available to the public, so you can also perform a 

similar search. However, once you have done your own research and you are still 

unsure about whether the product is a medical device, you can contact us. In the next 

few slides, we will go through the different mechanisms for obtaining feedback from us.

Slide 13

There are two mechanisms for obtaining device determination feedback from FDA. The 

first option is the informal approach, where you can send an email to the device 

determination mailbox. The second option is the more formal approach, where you can 

submit a 513(g) Request to FDA. We will discuss these mechanisms in the next few 

slides.

Slide 14

If you have a simple question that you believe can be addressed quickly, sending a 

device determination email inquiry is usually the best initial approach. To help us make 

a device determination, please include a brief device description, clear intended use,

and a list of all labeling claims in your email. In the device description, it helps when the 

device mechanism of action is described. In other words, how does the device 

accomplish its intend use? If available, provide a list or picture of the labeling claims. 

This will help us better understand the device, especially when the technology is novel,

and will also help us determine if they are medical in nature. The totality of this 

information is used to make a device determination.

Slide 15

Here’s an example of an email that would be appropriate to send to the device 

determination mailbox. I have a heat pack made of fabric that contains oats. The pack is 

heated in the microwave and can be reused. The heat pack is intended to provide pain 

relief and an increase in blood circulation. Is my product a medical device regulated by 

the FDA?

Slide 16

FDA provides a brief informal device determination response, and if there is information 

we believe could be helpful, such as a safety communication or a guidance document, 

we may include that information as well. Before we provide our response to the heat 

pack, I want to note that we typically provide a response within 7 days, and if you don’t 

hear back from us, we recommend reaching out again. We receive a large volume of 

emails and do our best to address them within a reasonable timeframe. There are 

situations where an inquiry is not truly simple, especially in situations where the product 

crosses different expertise and our subject matter experts need more time and 

information to provide an adequate response. In this situation, we would recommend 

submission of a 513(g) request.
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An example of a complex question could be a question such as, “I have a virtual reality 

game that helps to treat Alzheimer’s.” While video gaming is not something we typically 

regulate, the Alzheimer claim is a medical claim that warrants further review particularly 

by our subject matter experts. In such a situation, a 513(g) Request would be 

recommended. 

Slide 17 

As I mentioned in the previous slide, FDA’s response is often brief. Our response to the 

heat pack inquiry example indicates that the product is a medical device. This decision 

was based on the medical intended use pertaining to pain relief and increased blood 

circulation. I also want to note that the feedback we provide via email is not binding. 

Additionally, our response is not a classification decision and does not constitute FDA 

clearance or approval for commercial distribution of a product.

Slide 18

The other option is a formal 513(g) Request for Information. So, what is a 513(g)? A 

513(g) is a request for classification information and regulatory requirements for a 

particular product. 513(g) Requests are also referred to as 513(g)s, in short.

Slide 19

Most 513(g) submissions typically do not exceed 15 pages. This slide lists the 

information we recommend including in a 513(g) in order to help us make a device 

determination and classification recommendation. This includes the cover letter, device 

description, the device intended use, and labeling claims. Please reference the 

guidance listed on this slide for additional information. In the next few slides we’ll 

discuss each of these.

Slide 20

The cover letter is usually a page long and it should provide an overview of what is 

enclosed in the package. It should include the date of the request, company name, 

contact person, device name, contact information and the questions you have for FDA.

Slide 21

The device description should be clear and brief, and as I previously mentioned, 

explaining how the device accomplishes its intended use is very helpful. A picture or 

schematic of the device helps us to conceptualize how the device works. In your 

description, please also include the patient population and the disease or condition the 

device is intended for.

Slide 22

The intended use of the device is supposed to specify what the device is used for or its 

physiological purpose. For example, the device is intended to remove body fat.
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Slide 23

Labeling claims are usually promotional claims that are made beyond the intended use 

of the device. Assessment of these claims helps us to determine if a product is a 

medical device, the level of risk, and if performance data is required to support the 

claim. An example claim for a device is “the device removes 10% of body fat”. Such a 

claim would typically need to be supported by performance data. 

Slide 24

Questions associated with device determination, classification, and regulatory pathway 

are appropriate for a 513(g). Questions beyond that scope are not appropriate. 

Sometimes we see questions pertaining to performance data where the submitter is 

asking whether performance data is needed or appropriate. These types of questions 

are not appropriate for a 513(g). They are more appropriate for a Q-submission. 

Questions pertaining to requests for reclassification are not appropriate. For example, if 

you have a Class II device and you believe your device is also Class I, the 513(g) 

process is not the appropriate mechanism for addressing this issue. FDA has a 

separate reclassification process. FDA’s 513(g) response only addresses inquiries 

appropriate for a 513(g). 

Slide 25

This slide provides a very high-level overview of the 513(g) review process. All 513(g)s 

are received via CDRH’s document control center. 513(g)s are associated with a user 

fee and have ecopy requirements. These requirements are checked before a 

submission is assigned to a lead reviewer in a Division. The lead reviewer provides a 

review and recommendation. Final concurrence is then provided by senior management 

before the letter is issued to the submitter. For additional information on the FDA user 

fee program and eCopy requirements, please refer to the links provided on this slide.

Slide 26

The lead reviewer makes a device determination and classification recommendation 

based on the technology, intended use, and medical claims associated with a device. 

As part of the review process, we refer to the regulations and consider precedent set by 

existing medical devices. During the review, the lead reviewer may ask for additional 

information if it’s needed to help make a recommendation. Additionally, the lead 

reviewer may work with internal subject matter experts during the course of a review. A 

recommendation is provided within 60 calendar days.

Slide 27

FDA provides a response via a formal letter. The letter specifies whether or not the 

product is a medical device. If it is a medical device, we provide a recommended 

classification based on the information provided. 
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There are situations where we might not indicate a classification, especially in situations 

where the product falls under enforcement discretion. We also recommend the 

appropriate regulatory pathway. In other words, we indicate which pre-market 

requirements are appropriate for the device. If there are available resources associated 

with the device, such as a guidance document, we may include a link to the resource as 

well.

Slide 28

This slide shows an example 513(g) Letter. 513(g) letters typically do not exceed two 

pages. The letter covers, among other things, the device determination, classification,

and the type of premarket submission required, if applicable. 

Slide 29

It’s important to note that information received via the mailbox or a 513(g) is not binding 

and does not constitute FDA clearance or approval for commercial distribution.

Additionally, information that we receive either via the mailbox or 513(g) is confidential. 

We do not post 513(g) letters or recommendations on a database like we do for most of 

our program areas.

Slide 30

If you have questions on how to submit a 513(g) or how much it would cost, FDA has a 

number of resources, including guidance documents, available to help you. We also 

have a website that explains the steps to take to determine whether a product is a 

medical device. 

Slide 31

We get a lot of questions about general wellness products, mobile medical apps, and 

software as a medical device. We also have guidance documents to help you better 

understand these product areas. These guidance documents are all available on FDA’s 

website. 

Slide 32

FDA also provides video training modules for your viewing pleasure on CDRH Learn 

and a text-based resource at Device Advice. Additionally, if you have a general question 

and want to talk to someone, do not hesitate to contact the Division of Industry and 

Consumer Education, also known as DICE for short. 

Slide 33

In summary, a product is considered a medical device if it meets the definition of a 

medical device as defined in Section 201(h) of the FD&C Act. There are two 

mechanisms to receive feedback from FDA - email CDRH for an informal device 

determination or submit a formal 513(g) request.
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Slide 34

Your call to action. What should you do if you have a product and you’re not sure 

whether it’s a medical device, or how the medical device is classified?

First, search for similar devices in FDA’s databases. If you’re still unsure, then, for a 

simple inquiry, email the device determination mailbox with all the necessary 

information so we can make an appropriate determination. 

For a complex inquiry, or if you’re seeking a formal classification determination, submit 

a 513(g) request for information. If you plan to submit a 513(g) request, please include 

all the necessary information in your submission as specified in the 513(g) guidance 

document. This information will help FDA provide you with a recommendation.

Thank you for joining us. Have a wonderful day.

END