Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map

 CLIA Guidance Document

The FDA announced that they have put out a Guidance for Industry and Food and Drug Administration Staff concerning the Clinical Laboratory Improvement Amendments of 1988 which provides Recommendations for Clinical Laboratory Improvement Amendments of 1988 on how to submit a Waiver Application
for manufacturers of In Vitro Diagnostic Devices

CLIA requires that clinical laboratories obtain a certificate from
the FDA before accepting materials derived from the human body for laboratory tests. Laboratories that perform only tests that are `simple' and that have an `insignificant risk of an erroneous result' may obtain a certificate of waiver. The FDA has the authority to determine under CLIA whether particular tests (waived tests) are simple and have an insignificant risk of an erroneous result. This guidance describes recommendations for device manufacturers seeking to submit information (CLIA waiver application) to FDA to support a determination that a cleared or approved in vitro diagnostic
(IVD) device meets this CLIA waiver standard.

In the guidance document, FDA recommends an approach for
manufacturers to demonstrate in a CLIA waiver application that a device
is simple and has an insignificant risk of erroneous result as required
under CLIA. FDA based the recommendations in the guidance document on interpretation of the law, experience with CLIA complexity
determinations, and comments and information from stakeholders.

For more information on this please contact mdi at info@mdiconsultants.com and reference CLIA Reg.

Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map