Per the Emergency Use Authorization for Battelle CCDS™:
- The Battelle Decontamination System has
neither been cleared or approved for the decontamination of compatible N95 respirators for multiple-user reuse by HCP to prevent exposure to SARS-CoV-2 and other pathogenic biological airborne particulates;
- The Battelle Decontamination System has
been authorized by FDA under an EUA;
- The Battelle Decontamination System is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices during the COVID-19 outbreak,
under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.