FDA WARNING_LETTER - Battelle Memorial Institute - October 07, 2020

The FDA issued a Warning Letter to Battelle Memorial Institute regarding non-compliance with Emergency Use Authorization (EUA) EUA200210 for its Critical Care Decontamination System (CCDS). The CCDS is authorized for decontaminating N95 respirators for reuse during the COVID-19 pandemic.

The FDA's August 7, 2020, letter requested information on Battelle's adverse event reporting process. Battelle responded on August 12, 2020, stating a process was in place and no reportable adverse events had been identified.

However, the FDA determined Battelle is not in compliance with Condition H of the EUA, which requires reporting and record collection processes per 21 CFR Part 803. Deficiencies include: 1. **Inadequate MDR Procedure (21 CFR 803.17(a)(1)):** The procedure lacks instructions for timely evaluation of events for MDR reportability and omits definitions for key terms like "becomes aware," "caused or contributed," "malfunction," and "serious injury," potentially leading to incorrect reportability decisions. 2. **Lack of Standardized Review Process (21 CFR 803.17(a)(2)):** No instructions for investigating MDR reportable events and evaluating their cause. 3. **Incomplete Transmission Systems (21 CFR 803.17