This guidance document is outdated and has been removed from CDRH's web site.
An archived copy may be obtained from CDRH's Division of Small Manufacturers,
International, and Consumer Assistance (DSMICA), please contact dsmica@cdrh.fda.gov.
Devices previously covered by this document that are eligible for 510(k) third
party review will retain "non-pilot" status pending CDRH's issuance
of updated guidance. Additional information about the third party review program
is available at http://www.fda.gov/cdrh/thirdparty/.
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