Two panel members and the industry and patient representatives recommended Class 2 for the devices. Additionally, a majority of the panel agreed that based on the available data they could not say which electrical stimulation characteristics or what parameter ranges are the most critical for effective stimulation. The panel was convened to address the merits of three citizen petitions that sought to challenge an FDA proposal to classify the devices into Class 3 and keep the devices under the 510(k) pathway.
One of the petitioners, Electromedical Products International (EPI), said receiving FDA-prepared advisory committee briefing documents within the customary 48-hour advance notice period was inadequate to prepare a sufficient rebuttal to the agency’s position on Class 3 for the devices. EPI has marketed a CES device called the Alpha Stim since 1981 that is cleared under the 510(k) process for treating anxiety, insomnia, and depression. It says over eight million Alpha-Stim treatments were administered between 2007 and 2011.
“This FDA document was made available to the public, including EPI, within the last 48 hours, an insufficient time for EPI and its advisors to analyze the 85 pages of text,” the company complained in a statement released during the panel meeting. “In spite of prior requests to meet with the FDA and its efforts to obtain information through FOIA requests, EPI has been denied the basic right to dialog with the unknown people who constitute FDA. The panel review process cannot be adequately completed [until] the anonymous authors and supervisors responsible for the document are accessible and accountable for the opinions expressed in the Executive Summary. FDA’s Executive Summary rings hollow because of anonymity, [and is] absence of ‘valid scientific evidence’ support.”
EPI said it expected that FDA would produce documents requested under FOIA and would be available to discuss the findings of the Executive Summary. “Companies which have been serving patients in a safe and effective manner for 31 years deserve that form of transparency from their regulatory bodies,” it said.
EPI said the prepared questions for the panel on “key risks” identified by FDA are a hypothetical list that do not apply to EPI’s Alpha-Stim and for which there is no scientific or statistical support within FDA’s definition of valid scientific evidence. “For example, the ‘potential risk of seizure’ is an absurd fabrication for which FDA has produced no evidence, and EPI has never observed an incidence of during its 31 years of existence.”
EPI further said its petition for reclassification “is not a pre-market approval application for which submission of more stringent safety and effective data is a requirement. The objective is to recognize that the criteria for Class 3 devices do not apply and continued compliance with Class 2 requirements is sufficient to justify official recognition as a Class 2 device. The key for Class 2 is to provide FDA with a reasonable assurance of safety and effectiveness.”