intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or.recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,.2ĭevice: An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is. 134.Īpplicant: An individual, partnership, company, corporation, association, or other organization that designs, manufactures, assembles, or controls the assembly of a respirator and who seeks to obtain a certificate of approval for such respirator. Also, please note that the respirators described in this section and throughout this MOU are designed to be used in the context of a comprehensive respiratory protection program as required by the Occupational Safety and Health Administration (OSHA) in. Specifically, this MOU (1) describes the mechanisms by which specific information pertaining to N95s may be exchanged between the two Agencies and (2) provides a framework for efficient and coordinated regulatory oversight of N95s intended for use in healthcare settings.ĭefinitions of specific terms used in this MOU are provided in this section. The intent of this MOU is to help reduce conflicting and duplicative premarket processes for these devices so that stakeholders can easily and seamlessly discern what steps must be taken to satisfy the applicable regulatory requirements. This Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA), acting through its Center for Devices and Radiological Health (CDRH), and the Centers for Disease Control and Prevention (CDC), acting through its National Institute for Occupational Safety and Health (NIOSH), National Personal Protective Technology Laboratory (NPPTL) (herein referred to as “the Agencies”), provides a framework for coordination and collaboration between the Agencies relating to their regulation of Surgical N95 Respirators and N95 Filtering Facepiece Respirators (FFRs) 1 used in healthcare settings (herein collectively referred to as “N95s”).Ī coordinated process will help to ensure that the various regulatory activities of each agency related to N95s are streamlined and harmonized when possible. Institute for Occupational Safety & Health/National Personal Memorandum of Understanding Between the Food & DrugĪdministration/Center for Devices & Radiological HealthĪnd the Centers For Disease Control & Prevention/National
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