This article was originally published in The Gray Sheet
Executive SummaryAppeals of decisions by FDA's Office of Device Evaluation are best addressed to the branch chief, deputy director, or director of the appropriate review division, FDA and the Least Burdensome Industry Task Force recommend in a July 31 document. If "least burdensome" disputes are still unresolved, a firm may contact the ODE program operations staff, and if necessary, file an appeal under 21 CFR 10.75 with the ODE director. While the document suggests that the Center for Devices and Radiological Health ombudsman be contacted after a formal appeal fails, it notes that the ombudsman may be contacted at any point in the process. In addition to deficiency letters, the appeals mechanism may be used if any "aspect of a guidance document poses an inappropriate burden"
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