The new guidelines outlined in the ECSA-15-003 describe what information registrants are supposed to provide to the FDA in order to facilitate the review of applications to add electrostatic sprayor application instructions for use against SARS-coV-2. In particular, the guidelines address the need for ECOSHA approval as an additional safety standard. Specifically, the guidelines state that the ECOSHA approval process must be used to provide evidence of the effectiveness of an electrostatic agent in treating or preventing human exposure to SARS-coV-2 or a comparable pathogen.
Electrostatic sprayers are the most common method for removing the pathogens that cause the SARS outbreak. Electrostatic agents have been effective against pathogenic microorganisms such as Mycoplasma genitalium, Giardia, and E. coli. They have also been effective against the SARS virus.
In order for an ECOSHA approval review to be approved, the following information must be provided by the applicant: A description of the ECOSHA protocol to be used and all laboratory confirmation methods used; A demonstration of the ECOSHA protocol in the laboratory, including biological safety studies, a description of the laboratory analysis of ECOSHA protocol samples, and a description of the procedures that were used to test the validity of the protocol; and A review by the FDA’s Office of Special Agents of the clinical study reports, if any, describing the effectiveness of the ECOSHA protocol in the laboratory. The clinical study reports should be submitted to the FDA under a different name to facilitate the reviewer’s review.
These clinical study reports are required in order for ECOSHA approval to be considered as an additional safety measure. The clinical study reports must contain enough information to demonstrate that a person who uses the electrostatic sprayer has not developed a serious adverse health effect from the use of the spray or that the risks of developing such an effect are too remote to warrant ECOSHA approval.
The FDA’s Office of Special Agents provides guidelines and recommendations for the submission of ECOSHA approval information to the FDA. The guidelines require that a clinical study report be submitted to the FDA using the name of the company that manufactured the ECOSHA sprayer. A more specific example of this would be the manufacturer’s name in the title of the clinical study report for a certain ECOSHA spray for disinfection against SARS. or a similar pathogen.
Another part of the guidelines from the Office of Special Agents is the requirement that ECOSHA approval documentation be submitted with the completed ECOSHA approval request form. This form is a lengthy and detailed document that includes the clinical study reports of the ECOSHA protocol that are submitted with the application for approval. It requires the submission of the clinical study reports and laboratory confirmation results and provides information regarding the data collected for the clinical study. This information is used for the FDA’s review of the application for ECOSHA approval as an additional safety precaution.
The ECOSHA clinical study report is not used alone to grant ECOSHA approval. The clinical study reports are not required to obtain the ECOSHA approval.
In order to obtain the ECOSHA approval for the use of an electrostatic agent against a pathogen, the application must contain a declaration by the applicant that he or she is aware of all relevant facts regarding the possible adverse effects of his or her proposed use of the electrostatic agent on humans. The applicant must submit to the FDA a declaration that demonstrates that his or her use of the ECOSHA spray will not have any effect on human health.