Case Study:

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

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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

*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
Learning Objective

Describe how to approach classifying a product using three 

different 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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Traction Device 

Intended Use: To treat low back pain through 

intermittent and static traction

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Classification Determination Methods

Search for an appropriate product 

classification

Search for a similar device by clearance 

or approval

Search for a similar device by device 

listing

1

2

3

Most 

Common

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Classification Determination Methods

Search for an appropriate product 

classification

Search for a similar device by clearance 

or approval

Search for a similar device by device 

listing

1

2

3

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Method 1: 

Search Product Classification Database

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

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Method 1: Search Product Classification

Search Reminders:

• Conduct multiple searches using a variety of related terms

• Ensure correct spelling

• Avoid plurals

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Method 1: Search Product Classification

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Method 1: Search Product Classification

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Method 1: Search Product Classification

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Method 1: Search Product Classification

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Method 1: Search Product Classification

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Method 1: Search Product Classification

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Method 1: Search Product Classification

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Classification Determination Methods

Search for an appropriate product 

classification

Search for a similar device by clearance 

or approval

Search for a similar device by device 

listing

1

2

3

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Method 2: Search for a Similar Device 

• 510(k) Clearance 

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

• PMA Approval 

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

• De Novo Database 

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

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Method 2: Search by 510(k) Clearance

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Method 2: Search 510(k) Clearance

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Method 2: Search 510(k) Clearance

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Method 2: Search 510(k) Clearance

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Method 2: Search 510(k) Clearance

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Method 2: Search 510(k) Clearance

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Classification Determination Methods

Search for an appropriate product 

classification

Search for a similar device by clearance 

or approval

Search for a similar device by device 

listing

1

2

3

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Method 3: 

Search Establishment Registration and Device Listing Database

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

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Method 3: Search Device Listing

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Method 3: Search Device Listing

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Method 3: Search Device Listing

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Method 3: Search Device Listing

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Product Classification Example

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Powered Traction Device

Class II

Regulatory Controls General

*No special controls identified. 

Regulation 21 CFR 890.5900

Product Code ITH

Premarket Submission 510(k)
Summary

• There are three classification determination 

methods available to you. 

• Utilizing these methods will help you determine 

how your medical device may be classified. 

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Resources

Slide 

Number

Cited Resource URL

8 Product Classification Database www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm

18 510(k) Clearance Database www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm

18 Premarket Approval (PMA) 

Database

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

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

26 Establishment Registration and 

Device Listing

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

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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

• Conduct multiple 

searches in each of the 

databases 

• Cross-check yourself by 

utilizing all three 

classification 

determination methods 

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