Medical Devices
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Exempt Device Review Form
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 |
|
| 1 | Does 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 | |
| 5 | Device is not 510(k) exempt, perform a normal review. |
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