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U.S. Department of Health and Human Services

Medical Devices

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Exempt Device Review Form

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THIS FORM REPLACES THE “SUBSTANTIAL EQUIVALENCE DECISION MAKING DOCUMENTATION” FOR EXEMPT DETERMINATIONS.

____________________________________________ Date:

__________________________Exempt Device Review Form_______________

K

Contact:

Company Name:
Address:


510(k) Number:
Tradename:
Dated:
Received:

Product Code:
Class:
FR Classification No.:

Manufacturing Address:

Common Name:

Intended Use:

 Exempt Device Decision Table

Yes

No

1Does the device description match the exempt definition?

 

Go to 2

 

Go to 5

2

Does the device involve new technology?

 

 

Go to 5

 

Go to 3

3

Does the device have new indications?

 

 

Go to 5

 

Go to 4

4

 

The device is exempt from 510(k).Prepare Exempt Letter 
5Device is not 510(k) exempt, perform a normal review.