Is My Product a Medical Device? 

CDR Kimberly Piermatteo, MHA

Consumer Safety Officer

Division of Industry and Consumer Education

Office of Communication and Education

Center for Devices and Radiological Health

U.S. Food and Drug Administration
Medical Devices Are Diverse

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Simple Complex
Learning Objectives

1. Define what is a medical device

2. Discuss special considerations 

3. Discuss an example of a device determination 

4. Identify ways to request further assistance

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Definition of a Medical Device

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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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Examples of Excluded Software

Per Section 520(o)

• Administrative support of a health care facility; 

• Maintaining or encouraging a healthy lifestyle unrelated to the 

diagnosis, cure, mitigation, prevention, or treatment of a disease or 

condition;

• Serve as electronic patient records; or 

• Transferring, storing, converting formats, or displaying test or other 

device data, results or findings but not intended to interpret or 

analyze them. 

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Know Your Product

• What is the intended use of your product?

• How does your product function?

• What claims do you intend to make?

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Defining Your Intended Use is Key!

• Clearly state the general purpose or its 

function

• Further describe:

– The disease or condition the product will 

diagnose, cure, mitigate, treat or prevent 

– The intended patient population

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Is There an Existing

Product Classification?

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Product Classification Database

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Product Classification Database: 

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
Special Considerations

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In Vitro Diagnostics (IVDs)

• Reagents, instruments, and systems intended for use in 

the diagnosis of disease or other conditions. 

– Collect, prepare, and examine specimens taken from 

the human body 

– Can be used in a laboratory, health professional setting 

or at home

• Examples: Home Pregnancy Test, Glucose Test Strip

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Radiation Emitting Products

• Section 531 of the FD&C Act defines an electronic product 

as a product which when in operation (i) contains or acts as 

part of an electronic circuit and (ii) emits electronic 

product radiation

– Most radiation-emitting products are not medical devices

– Some radiation-emitting products with medical applications and claims 

meet the definition of medical device

• Examples: Diagnostic Ultrasound, X-Rays, Medical Lasers

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Mobile Medical Applications

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Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications: 

www.fda.gov/regulatory-information/search-fda-guidance-documents/mobile-medical-applications
Mobile Medical Applications

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Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications:

www.fda.gov/regulatory-information/search-fda-guidance-documents/mobile-medical-applications
Software as a Medical Device (SaMD)

• SaMD defined as:

– “software intended to be used for one or more medical 

purposes that perform these purposes without being part 

of a hardware medical device”

• Example: Software that allows a smartphone to view images 

obtained from a magnetic resonance imaging (MRI) medical 

device for diagnostic purposes 

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General Wellness Products

Products must meet the following two factors: 

1. Are intended for only general wellness use, as defined in 

the guidance, and 

2. Present a very low risk to users’ safety.

Guidance for Industry and Food and Drug Administration Staff - General 

Wellness: Policy for Low Risk Devices: 

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

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Combination Products

• 21 CFR 3.2(e): Combination products are therapeutic and 

diagnostic products that combine drugs, devices, and/or 

biological products 

• Lead center is based on a determination of the “primary 

mode of action” (PMOA) 

• Examples: Drug Eluting Stent, Heparin Coated Dialysis 

Catheter, First-Aid Kit with a Drug 

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Products Regulated by Other FDA Centers

• Center for Drug Evaluation and Research (CDER): 

www.fda.gov/drugs

• Center for Biologics Evaluation and Research (CBER): 

www.fda.gov/vaccines-blood-biologics

• Center for Veterinary Medicine (CVM): 

www.fda.gov/animal-veterinary

• Center for Tobacco Products (CTP): 

www.fda.gov/tobacco-products

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Device Determination Example

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Which product is a medical device?

Adult Diaper Infant Diaper

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VS.
Define the Intended Use

Adult Diaper Infant Diaper

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VS.

Intended to protect an 

adult’s garments from urine 

or stool.

Intended to protect 

an infant’s garments 

from urine or stool.
Further Define the Intended Use

Adult Diaper Infant Diaper

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VS.

Intended to protect an 

incontinent patient's 

garment from urine or stool. 

Intended to protect an 

infant’s garments from 

urine or stool.
Medical Device Definition Questions Adult 

Diaper

Infant 

Diaper

1 Is it intended to diagnose, cure, mitigate, treat, or 

prevent disease in a human?

2 Is it intended to affect the structure or any 

function of the body?

3 Does it achieve its primary intended purpose by 

chemical action or by being metabolized?

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Medical Device Definition Questions Adult 

Diaper

Infant 

Diaper

1 Is it intended to diagnose, cure, mitigate, treat, or 

prevent disease in a human? Yes No

2 Is it intended to affect the structure or any 

function of the body? No No

3 Does it achieve its primary intended purpose by 

chemical action or by being metabolized? No No

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Medical Device Definition Questions Adult 

Diaper

Infant 

Diaper

1 Is it intended to diagnose, cure, mitigate, treat, or 

prevent disease in a human? Yes No

2 Is it intended to affect the structure or any 

function of the body? No No

3 Does it achieve its primary intended purpose by 

chemical action or by being metabolized? No No

Does it meet the definition of a medical device? Yes No

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Is there an existing product 

classification?

Adult Diaper Infant Diaper

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VS.
Search the Product Classification Database

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Product Classification Database; 

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
Quick Search

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Quick Search

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Quick Search Results

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Quick Search Results

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Product 

Classification 

“Garment, 

Protective, For 

Incontinence”

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Product 

Classification 

“Garment, 

Protective, For 

Incontinence”

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Regulation Description 

“Garment, Protective, For Incontinence”

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Regulation Description 

“Garment, Protective, For Incontinence”

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Questions Adult 

Diaper

Infant 

Diaper

Is there an existing product classification? Yes No

Is the product regulated as a medical 

device? Yes No

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Further Assistance

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Informal Assistance

• Contact the Division of Industry and Consumer Education (DICE) 

– Phone: 1-800-638-2041 

– Email: dice@fda.hhs.gov

• Email the Device Determination experts 

(DeviceDetermination@fda.hhs.gov)

 Responses are not classification decisions and do not constitute 

FDA clearance or approval for commercial distribution

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Formal Assistance

• Appropriate when a formal determination is requested

• Submit a 513(g) Request

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

the Federal Food, Drug, and Cosmetic Act; www.fda.gov/regulatoryinformation/search-fda-guidance-documents/fda-and-industry-proceduressection-513g-requests-information-under-federal-food-drug-and-cosmetic

 Responses do not constitute FDA clearance or approval for 

commercial distribution

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Summary

• Medical devices are defined under Section 201(h) of 

the FD&C Act

• A clearly defined intended use is key

• Identifying an existing medical device product 

classification can be helpful

• Consider further assistance if necessary

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Resources

Slide 

Number

Cited Resource URL

5 Is the Product A Medical 

Device?

www.fda.gov/medical-devices/classify-your-medical-device/productmedical-device

12, 27 Product Classification Database www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

14 In Vitro Diagnostics [Homepage] www.fda.gov/medical-devices/products-and-medicalprocedures/vitro-diagnostics

14 Overview of IVD Regulation www.fda.gov/medical-devices/ivd-regulatory-assistance/overviewivd-regulation

15 Getting a Radiation Emitting 

Product to Market

www.fda.gov/radiation-emitting-products/electronic-productradiation-control-program/getting-radiation-emitting-productmarket

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Resources

Slide 

Number

Cited Resource URL

15 Radiation-Emitting Products 

Industry Assistance: Walk-through

www.fda.gov/radiation-emitting-products/getting-radiationemitting-product-market/radiation-emitting-products-industryassistance-walk-through

16 Mobile Medical Applications www.fda.gov/medical-devices/digital-health/mobile-medicalapplications

16 Guidance for Industry and Food 

and Drug Administration Staff 

[February 2019] - Mobile Medical 

Applications

www.fda.gov/regulatory-information/search-fda-guidancedocuments/mobile-medical-applications

18 Software as a Medical Device 

(SaMD)

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

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Resources

Slide 

Number

Cited Resource URL

19 Guidance for Industry and Food 

and Drug Administration Staff [July 

2016] - General Wellness: Policy for 

Low Risk Devices

www.fda.gov/regulatory-information/search-fda-guidancedocuments/general-wellness-policy-low-risk-devices

20 Combination Products www.fda.gov/combination-products

38 Device – Not a Device www.fda.gov/medical-devices/classify-your-medicaldevice/device-not-device

39 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-guidancedocuments/fda-and-industry-procedures-section-513g-requestsinformation-under-federal-food-drug-and-cosmetic

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Providing Industry Education

1. CDRH Learn – Multi-Media Industry Education

 over 100 modules - videos, audio recordings, PowerPoint presentations, 

software-based “how to” modules

 accessible on your portable devices: www.fda.gov/CDRHLearn

2. Device Advice – Text-Based Education

 comprehensive regulatory information on premarket and postmarket topics: 

www.fda.gov/DeviceAdvice

3. Division of Industry and Consumer Education (DICE)

 Email: DICE@fda.hhs.gov

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

30 pm ET)

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Your Call to Action

Familiarize yourself with:

• The definition of a medical 

device; and 

• FDA’s public product 

classification database

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