CLIA waived devices provide numerous benefits to the healthcare industry and patient care, including a broader market for manufacturers, rapid patient testing, diagnosis and treatment within an office visit, and reduced laboratory overhead and licensing costs. However, designing a CLIA waived device comes with its own challenges of ensuring the device is simple and accurate, with an insignificant risk of an erroneous result.
BACKGROUND ON CLIA
The Clinical Laboratory Improvement Amendments (CLIA) basic standards for quality, proficiency testing, and competency in the laboratory were first created in 19671. Continued reports of problems with “quality” in clinical labs forced the original CLIA ’67 act to be re-evaluated and amended.
Tensentric’s team is equipped to support CLIA waived device design efforts with years of experience designing simple and accurate devices that meet the waived test criteria set forth by the FDA.
Twenty years later, Congress passed the CLIA act of 19882, which expanded the scope of CLIA ’67 and established standards of accuracy, reliability, and timeliness. When designing a device to be CLIA waived in today’s world, manufacturers must work with three different agencies, including the Food and Drug Administration (FDA) for device approvals based on test complexity, the Center for Medicaid Services (CMS) for laboratory certificates, and the Center for Disease Control (CDC) for updates regarding CLIA.
WHAT DEFINES A CLIA WAIVED DEVICE?
CLIA waived devices are a subset of Point of Care (POC) devices, which are all a subset of laboratory devices. POC devices are designed for use near patient testing, usually smaller and easier to use than laboratory devices, but are typically categorized as moderate complexity. The differentiating factor between POC devices and CLIA waived devices is that CLIA waived devices are considered simple and have demonstrated that they meet the CLIA waiver criteria set forth by the FDA.
CLIA waived tests are defined as “simple laboratory examinations and procedures that have been approved by the FDA for home use or that… have an insignificant risk of an erroneous result”. Being “simple” means minimizing cognitive work for the user and designing for actionability. Example characteristics of being “simple” include:
- Intuitively obvious; anyone can do it
- No learning curve; does not require training
- No sample manipulation
- Only basic maintenance (e.g. changing a battery) and cleaning required
- Quick reference sheet written at 7th grade level
- Lock-out mechanisms prevent foreseeable system misuse
- Device calibration performed with each test automatically
- Easy to transfer sample into test kit; automatic detection of correct volume
- Test results are unambiguous; results do not require expert interpretation or further calculations
A device with an “insignificant risk of erroneous result” does not mean it is fool-proof, but rather the device employs methodologies such as Fail-Safe and Failure Alert mechanisms that facilitate correct user actions and mitigate use-related risk. Fail-Safe mechanisms are designed so that nothing dangerous happens if there is a failure within the system, for instance, lock-out features that ensure no result is shown if reagents expire or physical features that only afford the correct placement of system components. Failure Alert mechanisms are designed to alarm or notify the user when there is a failure in the system, which allows the user to correct the failure before proceeding with system use.
When designing a device for CLIA waiver, ask yourself first, is the test system simple? And second, does the test system have an insignificant risk of an erroneous result? Depending on your answers to those questions, your device may be a good candidate for CLIA waiver.
Tensentric offers best in class training in designing devices and tests to meet the requirements of CLIA waiver. Contact us at firstname.lastname@example.org for more information on how we can help.
WHY DESIGN FOR CLIA WAIVER?
There are many benefits to designing CLIA waived devices that overall lead to better and faster patient care. With the market for laboratory devices large and growing fast, the benefits for designing for CLIA waiver are even more important.
For manufacturers, designing for CLIA Waiver vastly broadens the potential market to include non-lab and non-hospital clinics, urgent care centers, medical facilities with a Certificate of Waiver (COW), and even home care.
For patients and providers, designing for CLIA Waiver improves patient care by streamlining urgent testing with access to near-immediate test results for in-office diagnosis and treatment.
HOW DOES A DEVICE GET CLIA WAIVED?
There are three different pathways3 for your device to become CLIA waived. First, your device may fall into any of the pre-approved test categories determined by the CMS, such as urine pregnancy tests, urine dipstick tests and many more. Be sure to reference their website4 for the most recent list of approved test categories.
Second, if your device receives FDA clearance for home use or over the counter use, then by law it is considered to be CLIA waived. If you are planning on following this pathway for your device to become CLIA waived, ensure your device meets the home use device criteria set forth by the FDA.
Third, if your device does not fall into the other two categories discussed, it can become CLIA waived by meeting the criteria set by the FDA5. This pathway involves the FDA scoring your device’s test complexity based on 7 key criteria by reviewing the package insert test instructions. This pathway is discussed further in the next section.
CLIA WAIVER BY APPLICATION
The FDA categorizes diagnostic tests by their complexity—from the least to the most complex: waived tests, moderate complexity tests, and high complexity tests. The FDA determines the test’s complexity by reviewing the package insert test instructions and evaluating the test using specific criteria to categorize a test as moderate or high complexity4. Each test is graded for level of complexity by assigning scores of 1, 2, or 3 for each of the seven criteria shown below.
A score of 1 indicates the lowest level of complexity, and the score of 3 indicates the highest level. The 7 scores are added together and devices with a score of 12 or less are categorized as moderate complexity, while those with a score above 12 are categorized as high complexity. Usually within two weeks of a device’s marketing clearance, the FDA will notify the sponsor of their CLIA categorization. If a device receives a categorization of moderate complexity, the manufacturer may request categorization of the test as waived by submitting a CLIA Waiver by Application (CW) submission to the FDA3.
- CLIA waived devices are test systems that are simple and have an insignificant risk of an erroneous result.
- Designing CLIA waived devices leads to faster and better patient care, along with many other benefits.
- There are three different pathways for a device to become CLIA waived: (1) by falling into the pre-approved test categories determined by CMS, (2) by law through FDA clearance/approval for home use, and (3) by CLIA Waiver by Application.
Tensentric is a team of highly experienced engineers developing a wide range of medical devices and in vitro diagnostic systems. Tensentric has completed over 300 development projects for clients in the medical device and IVD space since the company’s inception in 2009 and is ISO 13485:2016 certified for design and manufacturing.
- https://www.govinfo.gov/content/pkg/STATUTE-81/pdf/STATUTE-81-Pg533.pdf ↩
- https://www.govinfo.gov/content/pkg/STATUTE-102/pdf/STATUTE-102-Pg2903.pdf ↩
- https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-waiver-application ↩ ↩2
- https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/waivetbl.pdf ↩ ↩2
- https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clia-categorizations ↩