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Did the EUA for Covid Tests, Kill the 510k for them?
(Thursday, December 2, 2021) Why is there only one diagnostic test for Covid cleared by FDA under the 510k pathway after almost 2 years of the pandemic? FDA has granted emergency use authorizations (EUA) to 423 Covid tests, but it has only given one device 510k clearance, that too in March of this year, 9 months ago. The 510k pathway is the preferred pathway for market clearance for diagnostic tests. It creates a transparent and well-defined path to market approval where new devices simply need to demonstrate substantial equivalence to a previously cleared device. On the other hand, the EUA requires each device to conduct a significant battery of validation tests, each of which must be evaluated individually by FDA reviewers prior to authorization. Not only does the EUA process creates significant burden on the developers creating new tests that are practically identical to previously authorized tests, but it also creates an enormous workload for the FDA reviewers who need to evaluate each application as a brand-new device. This additional workload for both parties creates delays and unnecessary costs for both. In addition, unlike the 510k applications where the applicant pays a fee for review that allows FDA to make a decision about the application within the statutory time period of 90 days, the EUAs have no review fees and no statutory time period for response. There have been EUAs that were not even assigned reviewers by FDA months after their submission to the Agency. The 510k pathway has another benefit to the patients. All devices cleared by FDA under the 510k pathway can be used interchangeably as they are all substantially equivalent to each other increasing competition, access, and equal trust in all, something not present for devices “authorized” under the EUA program. It is not clear why the FDA has turned away from the well-established and trusted 510k pathway for Covid tests, instead relying on the EUA pathway which was always intended as a short-term arrangement till the traditional programs catch up. After 2 years and 423 EUAs, such “short-term” arrangement is hard to justify. The only logical explanation seems that the wide use of EUAs have choked the 510k applications. The developers with EUAs have no need to file a 510k application for selling their tests. Besides, no EUA holder would likely volunteer to be the first to file a 510k for their device unless FDA asks for it. And FDA has seemingly not encouraged any one to pursue formal approval, no explanation or justification provided. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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