![12/2/2025
Informal Assistance
41
• 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
Formal Assistance
42
• 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/regulatory-
information/search-fda-guidance-documents/fda-and-industry-procedures-
section-513g-requests-information-under-federal-food-drug-and-cosmetic
Responses do not constitute FDA clearance or approval for
commercial distribution
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
43
Resources
44
URL
Cited Resource
Slide
Number
www.fda.gov/medical-devices/classify-your-medical-device/product-
medical-device
Is the Product A Medical
Device?
5
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
Product Classification Database
12, 27
www.fda.gov/medical-devices/products-and-medical-
procedures/vitro-diagnostics
In Vitro Diagnostics[Homepage]
14
www.fda.gov/medical-devices/ivd-regulatory-assistance/overview-
ivd-regulation
Overview of IVD Regulation
14
www.fda.gov/radiation-emitting-products/electronic-product-
radiation-control-program/getting-radiation-emitting-product-
market
Getting a Radiation Emitting
Product to Market
15
41 42
43 44](https://image.slidesharecdn.com/slide29-250317020909-d5e0e0f8/85/FDA-SLIDES-FOR-YOUR-REFERENCE-ONLY-YA-pdf-11-320.jpg)
![12/2/2025
Resources
45
URL
Cited Resource
Slide
Number
www.fda.gov/radiation-emitting-products/getting-radiation-
emitting-product-market/radiation-emitting-products-industry-
assistance-walk-through
Radiation-EmittingProducts
Industry Assistance: Walk-through
15
www.fda.gov/medical-devices/digital-health/mobile-medical-
applications
Mobile Medical Applications
16
www.fda.gov/regulatory-information/search-fda-guidance-
documents/mobile-medical-applications
Guidance for Industry and Food
and Drug Administration Staff
[February 2019] - Mobile Medical
Applications
16
www.fda.gov/medical-devices/digital-health/software-medical-
device-samd
Software as a Medical Device
(SaMD)
18
Resources
46
URL
Cited Resource
Slide
Number
www.fda.gov/regulatory-information/search-fda-guidance-
documents/general-wellness-policy-low-risk-devices
Guidance for Industry and Food
and Drug AdministrationStaff [July
2016] - General Wellness:Policy for
Low Risk Devices
19
www.fda.gov/combination-products
Combination Products
20
www.fda.gov/medical-devices/classify-your-medical-
device/device-not-device
Device – Not a Device
38
www.fda.gov/regulatory-information/search-fda-guidance-
documents/fda-and-industry-procedures-section-513g-requests-
information-under-federal-food-drug-and-cosmetic
FDA and Industry Proceduresfor
Section 513(g) Requests for
Information under the Federal
Food, Drug, and Cosmetic Act
39
Providing Industry Education
47
1. CDRH Learn – Multi-MediaIndustry 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)
Your Call to Action
Familiarize yourself with:
• The definition of a medical
device; and
• FDA’s public product
classification database
48
45 46
47 48](https://image.slidesharecdn.com/slide29-250317020909-d5e0e0f8/85/FDA-SLIDES-FOR-YOUR-REFERENCE-ONLY-YA-pdf-12-320.jpg)
FDA SLIDES FOR YOUR REFERENCE ONLY YA.pdf
- 1. 12/2/2025 Is My Product a Medical Device? CDR Kimberly Piermatteo,MHA Consumer SafetyOfficer 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 Simple Complex 2 Learning Objectives 3 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 Definition of a Medical Device 4 1 2 3 4
- 2. 12/2/2025 Definition of a Medical Device 5 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: Definition of a Medical Device 6 (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 Definition of a Medical Device 7 (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). Examples of Excluded Software 8 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. 5 6 7 8
- 3. 12/2/2025 Know Your Product • What is the intended use of your product? • How does your product function? • What claims do you intend to make? 9 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 10 Is There an Existing Product Classification? 11 Product Classification Database 12 Product Classification Database: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm 9 10 11 12
- 4. 12/2/2025 Special Considerations 13 In Vitro Diagnostics (IVDs) 14 • 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 Radiation Emitting Products 15 • 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 Mobile Medical Applications Guidance for Industry and Food and Drug AdministrationStaff - Mobile Medical Applications: www.fda.gov/regulatory-information/search-fda-guidance-documents/mobile-medical-applications 16 13 14 15 16
- 5. 12/2/2025 Mobile Medical Applications Guidance for Industry and Food and Drug AdministrationStaff - Mobile Medical Applications: www.fda.gov/regulatory-information/search-fda-guidance-documents/mobile-medical-applications 17 Software as a Medical Device (SaMD) 18 • 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 General Wellness Products 19 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/general- wellness-policy-low-risk-devices Combination Products 20 • 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 17 18 19 20
- 6. 12/2/2025 Products Regulated by Other FDA Centers 21 • 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 Device Determination Example 22 Which product is a medical device? Adult Diaper Infant Diaper VS. 23 Define the Intended Use Adult Diaper Infant Diaper VS. 24 Intended to protect an adult’s garments from urine or stool. Intended to protect an infant’s garments from urine or stool. 21 22 23 24
- 7. 12/2/2025 Further Define the Intended Use Adult Diaper Infant Diaper VS. 25 Intended to protect an incontinent patient's garment from urine or stool. Intended to protect an infant’s garments from urine or stool. Infant Diaper Adult Diaper Medical Device Definition Questions Is it intended to diagnose, cure, mitigate, treat, or prevent disease in a human? 1 Is it intended to affect the structure or any function of the body? 2 Does it achieve its primary intended purpose by chemical action or by being metabolized? 3 26 Infant Diaper Adult Diaper Medical Device Definition Questions No Yes Is it intended to diagnose, cure, mitigate, treat, or prevent disease in a human? 1 No No Is it intended to affect the structure or any function of the body? 2 No No Does it achieve its primary intended purpose by chemical action or by being metabolized? 3 27 Infant Diaper Adult Diaper Medical Device Definition Questions No Yes Is it intended to diagnose, cure, mitigate, treat, or prevent disease in a human? 1 No No Is it intended to affect the structure or any function of the body? 2 No No Does it achieve its primary intended purpose by chemical action or by being metabolized? 3 No Yes Does it meet the definition of a medical device? 28 25 26 27 28
- 8. 12/2/2025 Is there an existing product classification? Adult Diaper Infant Diaper VS. 29 Search the Product Classification Database 30 Product Classification Database; www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm Quick Search 31 Quick Search 32 29 30 31 32
- 9. 12/2/2025 Quick Search Results 33 Quick Search Results 34 Product Classification “Garment, Protective, For Incontinence” 35 Product Classification “Garment, Protective, For Incontinence” 36 33 34 35 36
- 10. 12/2/2025 Regulation Description “Garment, Protective, For Incontinence” 37 Regulation Description “Garment, Protective, For Incontinence” 38 Infant Diaper Adult Diaper Questions No Yes Is there an existing product classification? No Yes Is the product regulated as a medical device? 39 Further Assistance 40 37 38 39 40
- 11. 12/2/2025 Informal Assistance 41 • 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 Formal Assistance 42 • 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/regulatory- information/search-fda-guidance-documents/fda-and-industry-procedures- section-513g-requests-information-under-federal-food-drug-and-cosmetic Responses do not constitute FDA clearance or approval for commercial distribution 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 43 Resources 44 URL Cited Resource Slide Number www.fda.gov/medical-devices/classify-your-medical-device/product- medical-device Is the Product A Medical Device? 5 www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm Product Classification Database 12, 27 www.fda.gov/medical-devices/products-and-medical- procedures/vitro-diagnostics In Vitro Diagnostics[Homepage] 14 www.fda.gov/medical-devices/ivd-regulatory-assistance/overview- ivd-regulation Overview of IVD Regulation 14 www.fda.gov/radiation-emitting-products/electronic-product- radiation-control-program/getting-radiation-emitting-product- market Getting a Radiation Emitting Product to Market 15 41 42 43 44
- 12. 12/2/2025 Resources 45 URL Cited Resource Slide Number www.fda.gov/radiation-emitting-products/getting-radiation- emitting-product-market/radiation-emitting-products-industry- assistance-walk-through Radiation-EmittingProducts Industry Assistance: Walk-through 15 www.fda.gov/medical-devices/digital-health/mobile-medical- applications Mobile Medical Applications 16 www.fda.gov/regulatory-information/search-fda-guidance- documents/mobile-medical-applications Guidance for Industry and Food and Drug Administration Staff [February 2019] - Mobile Medical Applications 16 www.fda.gov/medical-devices/digital-health/software-medical- device-samd Software as a Medical Device (SaMD) 18 Resources 46 URL Cited Resource Slide Number www.fda.gov/regulatory-information/search-fda-guidance- documents/general-wellness-policy-low-risk-devices Guidance for Industry and Food and Drug AdministrationStaff [July 2016] - General Wellness:Policy for Low Risk Devices 19 www.fda.gov/combination-products Combination Products 20 www.fda.gov/medical-devices/classify-your-medical- device/device-not-device Device – Not a Device 38 www.fda.gov/regulatory-information/search-fda-guidance- documents/fda-and-industry-procedures-section-513g-requests- information-under-federal-food-drug-and-cosmetic FDA and Industry Proceduresfor Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act 39 Providing Industry Education 47 1. CDRH Learn – Multi-MediaIndustry 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) Your Call to Action Familiarize yourself with: • The definition of a medical device; and • FDA’s public product classification database 48 45 46 47 48
- 13. 12/2/2025 49 49