How is My Medical Device Classified?

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
1. How is My Medical Device Classified?

2. Case Study: How is My Medical Device 

Classified?

How to Use this Presentation

2
Learning Objectives

1. Explain how medical devices are classified

2. Discuss the regulatory requirements for medical 

devices

3. Discuss classification determination methods

4. Identify ways to request additional assistance

3
Medical Device Classes

and Applicable Regulatory 

Requirements

4
Device Risk 

Class 

Extent of Regulatory Controls

5
Classes of Medical Devices

6

Class Risk Potential Harm Regulatory 

Controls

Submission Type or 

Exemption

Percent

Devices 

in Class*

I

II

III
Classes of Medical Devices

7

Class Risk Potential Harm Regulatory 

Controls

Submission Type or 

Exemption

Percent

Devices 

in Class*

I Lowest Present minimal potential for 

harm 

II Moderate Higher risk than Class I 

devices 

III Highest Sustain or support life, are 

implanted, or present 

potential unreasonable risk 

of illness or injury
Classes of Medical Devices

8

Class Risk Potential Harm Regulatory 

Controls

Submission Type or 

Exemption

Percent

Devices 

in Class*

I Lowest Present minimal potential for 

harm 

II Moderate Higher risk than Class I 

devices 

III Highest Sustain or support life, are 

implanted, or present 

potential unreasonable risk 

of illness or injury
What are “Regulatory Controls”

• General, Special or Premarket Approval 

• Apply to a particular device type

• Generally broad, but may be specific

• Describe the appropriate level of regulatory oversight 

to ensure reasonable safety and effectiveness

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Resource:

– Regulatory Controls: www.fda.gov/medical-devices/overview-deviceregulation/regulatory-controls
Classes of Medical Devices

10

Class Risk Potential Harm Regulatory 

Controls

Submission Type or 

Exemption

Percent

Devices 

in Class*

I Lowest Present minimal potential for 

harm 

General

II Moderate Higher risk than Class I 

devices 

General and 

Special 

(if available)

III Highest Sustain or support life, are 

implanted, or present 

potential unreasonable risk 

of illness or injury

General and 

PMA
Examples of General Controls

Control Regulation

(21 CFR Part)

Brief Description

Adulterated FD&CA 501 Provide device not proper for use

Misbranded FD&CA 502 Provide false or misleading labeling

Labeling 801 Provide information for users

Medical Device Reporting 803 Report device-related injuries and deaths

Establishment Registration 807 Register company with FDA

Device Listing 807 Identify devices with FDA 

510(k) Premarket Notification 807 Substantially equivalent to legally marketed 

device

Quality System/Good Manu. Practices 820 Ensure safe and effective finished devices

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FD&CA = Food, Drug and Cosmetic Act; CFR = Code of Federal Regulation
Examples of Special Controls

• Special Labeling

• Design Characteristics or Specifications

• Performance Standards

• Premarket Data Requirements

• Guidance Documents

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Premarket Approval

• Typically for life supporting or life sustaining devices

• General and Special Controls are insufficient to provide 

reasonable assurance of safety and effectiveness

• 21 CFR 814: 

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CF

RSearch.cfm?CFRPart=814

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Classes of Medical Devices

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Class Risk Potential Harm Regulatory 

Controls

Submission Type or 

Exemption

Percent

Devices 

in Class*

I Lowest Present minimal potential for 

harm 

General 510(k)

510(k) Exempt

(Most are exempt 

from 510(k))

II Moderate Higher risk than Class I 

devices 

General and 

Special 

(if available)

510(k)

510(k) Exempt

III Highest Sustain or support life, are 

implanted, or present 

potential unreasonable risk 

of illness or injury

General and 

PMA

PMA
FDA Product Codes

• Three letter codes 

(e.g., CBK, FRN)

• Used by FDA to 

identify and track 

similar medical 

devices

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Product Classification Database: 

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm
Regulations and Product Codes

Same Regulation Number (21 CFR 870.1875) 

Four Different Product Codes for Specific Device Types

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Device Type Class 510(k) Exempt? Product Code

Manual Stethoscope 1 Yes LDE

Electronic Stethoscope 2 No DQD

Cranial Sound Monitor 2 No QBE

Lung Sound Monitor 2 Yes OCR
Classes of Medical Devices

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Class Risk Potential Harm Regulatory 

Controls

Submission Type or 

Exemption

Percent

Devices 

in Class*

I Lowest Present minimal potential for 

harm 

General 510(k)

510(k) Exempt

*93% are exempt 

from 510(k)

35%

II Moderate Higher risk than Class I 

devices 

General and 

Special 

(if available)

510(k)

510(k) Exempt

53%

III Highest Sustain or support life, are 

implanted, or present 

potential unreasonable risk 

of illness or injury

General and 

PMA

PMA 9%

*3% of devices are Unclassified
Classification Determination 

Methods

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Classification Determination Methods

1. Search for an appropriate product classification

2. Search for a similar device by clearance or approval

3. Search for a similar device by device listing

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Classification Determination Methods

1. Search for an appropriate product classification

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• Product Classification Database: 

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

• Search for FDA product codes

• Most common method
Classification Determination Methods

2. Search for a similar device by clearance or approval

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• 510(k) Clearance Database: 

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

• Premarket Approval (PMA) Database: 

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm

• De Novo Database: 

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm
Classification Determination Methods

3. Search for a similar device by device listing

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• All establishments currently marketing a medical device must be 

registered and list their devices  A General Control 

• Establishment Registration and Device Listing Database: 

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
Additional Assistance

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Division of Industry and Consumer 

Education

• Contact the Division of Industry and Consumer 

Education (DICE)

– Phone: 1-800-638-2041 

– Email: dice@fda.hhs.gov

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Note: Responses are not classification decisions and do not constitute FDA 

clearance or approval for commercial distribution
513(g) Request 

• Appropriate when a formal product classification is requested

• 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

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Note: Responses do not constitute FDA clearance or approval for commercial 

distribution
Summary

• Medical devices are classified based on risk

• The risk of the device determines the extent of 

regulatory controls

• The class and regulatory requirements for a medical 

device may be determined by searching FDA’s public 

databases

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Resources

Slide 

Number

Cited Resource URL

1 How to Classify Your Medical 

Device

www.fda.gov/medical-devices/overview-deviceregulation/classify-your-medical-device

8 Regulatory Controls www.fda.gov/medical-devices/overview-deviceregulation/regulatory-controls

13 Class I/II Exemptions www.fda.gov/medical-devices/classify-your-medicaldevice/class-i-ii-exemptions

13 Premarket Notification 510(k) www.fda.gov/medical-devices/premarketsubmissions/premarket-notification-510k

13 Premarket Approval www.fda.gov/medical-devices/premarketsubmissions/premarket-approval-pma

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Resources

Slide 

Number

Cited Resource URL

14 Medical Device Classification 

Product Codes - Guidance for 

Industry and Food and Drug 

Administration Staff 

www.fda.gov/regulatory-information/search-fda-guidancedocuments/medical-device-classification-product-codes-guidanceindustry-and-food-and-drug-administration-staff

14, 19 Product Classification Database www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

15 Code of Federal Regulations 

(CFR) Search

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm

20 510(k) Clearance Database www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

20 Premarket Approval (PMA) 

Database

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm

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Resources

Slide 

Number

Cited Resource URL

20 De Novo Database www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/denovo.cfm

21 Establishment Registration and 

Device Listing

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

24 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

• Evaluate the risk of your device to determine the class and 

applicable regulatory controls

• Familiarize yourself with different classification determination 

methods

• View CDRH Learn Module - Case Study: How is My Medical 

Device Classified?

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