- FDA reissued draft guidance recommendations this week on how in vitro diagnostics manufacturers can best apply for Clinical Laboratory Improvement Amendments waivers, taking into account comments from AdvaMed's IVD division and others on the original updates issued November of last year.
- If a product is categorized as posing a moderate risk to users when initially approved by FDA, manufacturers can apply for a CLIA waiver to prove that it belongs in the waived category. CLIA-waived devices or tests can be used in CLIA-waived labs or by untrained users at home.
- The two separate guidances address how IVD manufacturers can demonstrate "insignificant risk of an erroneous result" and how certain study designs can also be used to apply for a dual 510(k)-CLIA waiver. The latest drafts will undergo another comment period until Feb. 27, 2019.
The 2017 updates to the 2008 version of IVD device guidance were mandated by the 21st Century Cures Act, while the recommendations regarding the dual 510(k)-CLIA waiver application build on the dual option's establishment in 2012 under the Medical Device User Fee Amendments (MDUFA III).
James Boiani, general counsel for the Coalition for CLIA Waiver Reform, argued in March that FDA needs to adhere to congressional intent in its guidance. "Congress has said that if a diagnostic test allows trained and untrained users to get comparable results, and the test is simple, it is entitled to a waiver," Boiani wrote on behalf of the group.
FDA responded to the recommendations by including more study design options for proving insignificant risk. The draft guidance now includes three comparative study designs and one alternative. The comparative studies can focus on quantitative and qualitative differences in test results when used by trained versus untrained operators or can be modeled on FDA's Assay Migration Studies for IVD Devices, while the alternative option may be used "for certain text systems, flex and human factors engineering studies."
FDA flagged study design Option 4 as "comparison study designs in which the results of the candidate test in the hands of 236 untrained operators are directly compared to the results of an appropriate comparative method in 237 the hands of trained operators," as particularly applicable to dual 510(k)-CLIA waiver applications.
AdvaMed views the latest updates as an improvement over 2017.
"While we are still reviewing the revised draft CLIA guidances, we appreciate FDA issuance of these guidances to support innovators who are working to bring critical new point of care technologies to patients," said Khatereh Calleja, AdvaMed SVP of technology and regulatory affairs, in a statement to MedTech Dive.
"These technologies are an important aspect of today’s health care. With the increasing need for timely point of care diagnostics from emerging infection disease to antibiotic resistance, improving patient care depends on physician access to these critical tests as part of today’s modern health care system."
Separately, the administration of CLIA also has the potential to be impacted by the the Diagnostic Accuracy and Innovation Act, depending on where the legislation goes. Introduced last year in the House, it would allow FDA to regulate laboratory developed tests within a new category of in vitro clinical tests.