US FDA Medical Device Classification

 Medical devices are classified based on intended use and indications for use. There are 3 classes I, II and III. Below figure shows the US FDA risk-based device classification.

The following options are available for accessories class identification,

1. Accessory used with single/same device: Same class as the parent device

2. Accessory used with multiple device: Different class as the parent device

How to determine the device class:

You should know the intended use and technology of the device. Device should meet the definition per section 201(h) of the FD&C Act

Medical device classes are determined using product classification database or classification panels.

Product classification database:

·       Contains device names and their associated product codes.

·       Search using device type and product code.

Click here to access product classification database 

Classification Panels (CFR Parts 862-892) :

·       Devices are grouped in medical specialty "panels" such as Cardiovascular devices or Ear, Nose, and Throat devices.

·       1,700 distinct types of devices grouped into 16 medical specialty 

Click here to know more about classification panels.

If you are not sure about device class. The following ways you can determine the device classification.

Informal:

Contact the Division of Industry and Consumer Education (DICE) email-dice@fda.hhs.gov

Email the Device Determination experts (DeviceDetermination@fda.hhs.gov)

Include the following information in your email: CDRH will respond within 7 days

1.     Brief device description

2.     Clear intended use

3.     List or picture of all Labeling claims

Formal:

Submit a 513(g) Request:

The following information should be submitted

1.Cover Letter

·       Date of the request

·       Company name

·       Contact person

·       Contact information (email and phone number)

·       Device Name

·       Question(s) to FDA

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

3.Intended Use

·       Describe what the device is used for

·       Physiological purpose

4.Labeling Claims or Promotional claims beyond the intended use

FDA shall respond via email within 60 calendar days. It provides the letter including device class, regulatory pathway and guidance document.

Denovo Classification Request:

Applicable for novel devices. Process for the classification of certain low-risk devices for which there is no predicate

Click here to know more about Denovo Classification Request

References:

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance

https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device

21 CFR 

https://www.fda.gov/training-and-continuing-education/cdrh-learn