CLIA Waived and FDA Clearance: What Does it Mean?

CLIA Waived and FDA Clearance: What Does it Mean?

Clinical Laboratory Improvement Amendments (CLIA) is a Federal regulation that establishes quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results.  The FDA categorizes commercially marketed tests into one of three CLIA categories according to complexity and their potential for risk to public health:

• Waived tests
• Tests of moderate complexity
• Tests of high complexity

CLIA Waived devices are the least complex.  In order to receive CLIA Waived status, a manufacturer must demonstrate that a device is simple to use, has low risk to public health, and that an untrained person can get accurate results by reading the instructions.

 The instruction sheet is what distinguishes a CLIA Waived device from an identical device that is not CLIA Waived.  Instruction sheets for CLIA Waived devices are written in simple to understand language and do not contain technical jargon.  There typically is no difference in the device itself from a CLIA Waived device and a device that does not have CLIA Waived status.

A device that is CLIA Waived does not require highly trained laboratory personnel to administer the test and does not require costly laboratory quality control testing.  Because non-professional staff is permitted to use CLIA Waived tests, the cost of testing is more economical and can be performed more timely by front-line staff.  Hospitals and laboratories that use devices that are not CLIA Waived typically must perform daily quality control testing on the devices to ensure they are giving accurate results.  This is typically not required of CLIA Waived devices.

FDA 510(k) Clearance:

Manufacturers must obtain FDA 510(k) clearance before selling their devices.  There are two types of FDA clearance for medical devices: Professional use and Over the Counter use.  Professional use is the typical FDA clearance, which means the device may be sold only to and used only by medical professionals.  A medical device manufacturer that wants to obtain CLIA Waived status for a device that already has FDA clearance for professional use must perform a number of additional studies to demonstrate the device can be safely used by untrained personnel.

FDA Over the Counter clearance means the device may be sold directly to and used by consumers.  By regulation, all devices that have FDA Over the Counter clearance are automatically CLIA Waived as well.