Third Party Review - How to Use This Program
|
|
Four Basic Steps
There are four basic steps to using the program.
- Check to see if your device is eligible. Look at the
list of eligible devices for the Accredited Persons Program to see if
the FDA classification regulation and product code for your device are listed.
Most Class I and Class II devices are eligible-more than 670 types of devices
in all. (If you do not know what classification regulation or product code
applies to your device, you can search FDA's
Device Classification Database. You can also contact an Accredited Person
or FDA's Division of Small Manufacturers, International and Consumer Assistance
at
dsmica@cdrh.fda.gov for additional guidance.)
- Determine
which Accredited Persons can review your 510(k) and how to contact them.
One method is to access the
list of eligible devices for the Accredited Persons Program, and then to click
on the product code for your device. This will display additional information
for the product code, including a list of any Accredited Persons that are eligible
to review that type of device. Clicking on the name of an Accredited Person will
display FDA's list of Accredited Persons, which provides information on contacting
the Accredited Person. Another method is to go directly to the
list of Accredited Persons. The list of Accredited Persons shows the devices
each organization is accredited to review, and contact information.
-
Obtain price quotes from one or more Accredited Persons, and contract for a review.
The fee for an Accredited Person's review is determined by agreement between
the 510(k) submitter and the Accredited Person, and is paid by the 510(k) submitter
directly to the Accredited Person. Before contracting for a review, you should
discuss any important factors such as the timeframe for the review.
-
Submit the 510(k) to the Accredited Person, with a letter authorizing the Accredited
Person to discuss the 510(k) with FDA and to forward it to FDA on your behalf.
Back to Third Party Review Home Page
Updated February 5, 2002
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH