513(g) Requests for Information 

Ifeanyi U. Uwemedimo, Ph.D.

Policy Analyst

Office of Regulatory Programs

Center for Devices and Radiological Health

U.S. Food and Drug Administration
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I have a product 

and I am not sure 

if it is a medical 

device?

I have a product 

and I am not 

sure how it is 

classified?

What do I do? 
Learning Objectives

1. Describe how FDA addresses device 

determination inquiries

2. Outline the 513(g) Request process

3. Explain when it is appropriate to send an informal 

device determination email or a formal 513(g) 

request for information

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Definition of a Medical Device

Section 201(h) of the Food, Drug & Cosmetic Act 

(FD&C Act) defines a device as: 

An instrument, apparatus, implement, machine, 

contrivance, implant, in vitro reagent, or other similar 

or related article, including a component part or 

accessory which is: 

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Definition of a Medical Device

(Continued)

• Recognized in the official National Formulary, or the United 

States Pharmacopoeia, or any supplement to them, 

• Intended for use in the diagnosis of disease or other 

conditions, or in the cure, mitigation, treatment, or 

prevention of disease in man or other animals, or

• Intended to affect the structure or any function of the body 

of man or other animals

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Definition of a Medical Device

(Continued)

• And does not achieve its primary intended purposes through 

chemical action within or on the body of man or other animals 

and which is not dependent upon being metabolized for the 

achievement of its primary intended purposes

• The term "device" does not include software functions 

excluded pursuant to section 520(o)

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Regulatory Classes

Class III

High Risk

(PMA)

Class II

Moderate Risk

(510(k))

Class I

Low Risk

majority are (510(k) Exempt)

Devices are classified based on level of risk
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Regulatory Classes

Class III

High Risk

(PMA)

Class II

Moderate Risk

(510(k))

Class I

Low Risk

majority are (510(k) Exempt)

Pre- market Approval (PMA)

Pre-market Notification 510(k)

510(k) Exempt = No 

510(k) submission 

required

Devices are classified based on level of risk
De Novo Classification Request 

(De Novo)

• Automatically been placed in Class III due to lack of an 

appropriate predicate

• Alternate pathway to classify novel devices of low to 

moderate risk 

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Acceptance Review for De Novo Classification Requests

www.fda.gov/regulatory-information/search-fda-guidance-documents/acceptancereview-de-novo-classification-requests
Device Categories

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There are different 

types of medical 

devices

Aesthetic General 

Wellness

Diagnostic Therapeutic

Mobile 

Medical 

Application

Software as a 

Medical 

Device 

(SAMD)

Combination 

Products
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Is My Product A Medical Device?
Your Device Determination Steps

1. Know the intended use and technology of the 

device. What does it do? How does it do it?

2. Does it meet the definition of a medical device per 

section 201(h) of the FD&C Act?

3. Check FDA databases for existing or similar device

Still Unsure? Obtain Feedback from Us 

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Submit a 513(g) 

Request

Email Device 

Determination 

Mailbox

Option 1 - Informal Option 2 - Formal

Mechanism For Obtaining Feedback 

CDRH provides quick and 

informal response

FDA provides formal 

response with device 

classification if applicable 
Option 1 - Informal Device 

Determination

• Email inquiry to Device Determination Team at: 

DeviceDetermination@fda.hhs.gov

• Include the following information in your email:

o Brief device description

o Clear intended use

o List or picture of all labeling claims

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Example Email Inquiry

• 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 

increase blood circulation

• Is my product a medical device regulated by the FDA?

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CDRH Informal Device 

Determination Response

• Yes/no response with additional relevant information 

(e.g. link to regulation or guidance document) when 

appropriate

• Generally provided within 7 days

• If inquiry is complex and cannot be adequately 

addressed via email, we may recommend submission 

of a 513(g) Request

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Example Email CDRH Response

• Based on the information you provided, the heat pack 

product appears to be a medical device per Section 

201(h) of the Federal Food Drug & Cosmetic (FD&C) 

Act

• This is our best judgment on how the product would 

be regulated. This response is not a classification 

decision and does not constitute FDA clearance or 

approval for commercial distribution of a product

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Option 2 - Formal Device 

Determination 513(g) Request

• Request for classification information and regulatory 

requirements for a particular product 

• Governs requests "for information respecting the class in 

which a device has been classified or the requirements 

applicable to the device."

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Information to Include in a 513(g) 

Request

1. Cover Letter

2. Device Description

3. Intended Use

4. Labeling Claims

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Guidance: FDA and Industry Procedures for Section 513(g) Requests for Information under the 

Federal Food, Drug, and Cosmetic Act

www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industryprocedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic
1. Cover Letter

• Date of the request

• Company name

• Contact person

• Contact information (email and phone number)

• Device Name

• Question(s) to FDA

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2. Device Description

• Brief description

• Describe mechanism of action

• Describe disease or condition the device is intended for

• Include picture or schematic, if available

• Patient population

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3. Intended Use

• Describe what the device is used for

• Physiological purpose

Example: The device is intended for removal of body fat

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4. Labeling Claims

• Promotional claims beyond the intended use

Example: Device removes 10% of body fat

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Types of 513(g) Questions

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• Is the product subject to FDA 

regulations?

• What is the appropriate 

regulatory pathway?

• Is the product exempt from 

510(k)?

• Type of performance data 

required?

• Adequacy of performance 

data?

• Adequacy of predicate? 

• Request for reclassification?

APPROPRIATE NOT APPROPRIATE 
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513 Request is 

received by FDA via 

the document 

control center and 

checked for user 

fee and eCopy 

Lead Reviewer 

reviews submission 

& provides 

recommendation

Overview of 513(g) Review Process

Management 

concurrence before 

letter issuance

FDA User Fee Programs

www.fda.gov/industry/fda-user-fee-programs

eCopy Program for Medical device Submissions

www.fda.gov/medical-devices/how-study-and-market-your-device/ecopy-program-medical-device-submissions
FDA Review 513(g) Request

• All information provided is reviewed by a lead reviewer, 

who may work with other subject matter experts

• Regulation and precedent set by existing medical devices is 

considered

• A medical device determination is made for the product 

based on technology, intended use and medical claims

• If needed additional information is requested

• FDA provides a recommendation and issues a letter via 

email within 60 calendar days

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FDA’s Response

• Response via formal letter

• Letter includes:

o Device determination

o Device class if applicable (i.e. Class I, II, or III)

o Indicate whether device is under enforcement discretion, when 

appropriate

o Recommended regulatory pathway (e.g. 510(k), exempt, De Novo, 

etc.)

o Other applicable information when appropriate (e.g. guidance 

document)

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513(g) Example Letter

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EXAMPLE
Responses and Information

• Responses provided via email or 513(g) are 

recommendations and not binding feedback and does not 

constitute FDA clearance or approval for commercial 

distribution of a product

• Stakeholder information provided via the device 

determination mailbox and 513(g) Request for Information 

is confidential

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References 

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• FDA and Industry Procedures for Section 513(g) Requests for Information under the 

Federal Food, Drug, and Cosmetic Act Guidance Document (2012) 

www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industryprocedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic

• User Fees for 513(g) Requests for Information Guidance (2017)

www.fda.gov/regulatory-information/search-fda-guidance-documents/user-fees-513grequests-information

• Is a product a medical device? FDA website 

www.fda.gov/medical-devices/classify-your-medical-device/product-medical-device
References

• General Wellness: Policy for Low Risk Devices Guidance (2016) 

www.fda.gov/regulatory-information/search-fda-guidance-documents/generalwellness-policy-low-risk-devices

• Medical Mobile Application FDA website 

www.fda.gov/medical-devices/digital-health/mobile-medical-applications

• Software as a medical device FDA website 

www.fda.gov/medical-devices/digital-health/software-medical-device-samd

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Providing Industry Education

1. CDRH Learn – Multi-Media Industry Education

• Videos, audio recordings, power point presentations, software-based “how to” 

modules describing aspects of medical device and radiation emitting product 

regulations: www.fda.gov/CDRHLearn

2. Device Advice – Text-Based Education

• Text-based resource that explains many aspects of medical device laws, regulations, 

guidances, and policies: 

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance

3. Division of Industry and Consumer Education (DICE)

• If you have a question - Email: DICE@fda.hhs.gov

• Phone: 1(800) 638-2041 or (301) 796-7100 (Live Agents 9a –12:30 pm; 1-4:30 pm 

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Summary

• A product is considered to be a medical device 

if it meets the definition in Section 201(h) of 

the FD&C Act

• There are two mechanisms to receive feedback, 

email us at device determination or submit a 

513(g) request

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Your Call To Action

• Search for similar devices in FDA databases

• Email DeviceDetermination@fda.hhs.gov for a simple 

inquiry

• Submit a 513(g) Request for a complex inquiry and/or if 

you are seeking device classification

• Refer to the FDA 513(g) Request For Information Guidance 

for instructions when submitting a 513(g)

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