Implementation of the emergency use authorities set forth in section 564A and.Issuance of Emergency Use Authorizations (EUAs) under section 564.This document is intended to inform all stakeholders 5 involved in emergency response activities and FDA staff of FDA's general recommendations and procedures for: The use of the word should in Agency guidance means that something is suggested or recommended, but not required. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. In general, FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. This guidance finalizes the draft guidance, Emergency Use Authorization of Medical Products and Related Authorities (April 2016) and replaces the following two guidance documents, Emergency Use Authorization of Medical Products (July 2007) and Emergency Use Authorization Questions and Answers (April 2009). These medical products, also referred to as “medical countermeasures” or “MCMs,” include drugs 4 (e.g., antivirals and antidotes), biological products (e.g., vaccines, blood products, and biological therapeutics), and devices (e.g., in vitro diagnostics and personal protective equipment). PAHPRA clarifies and enhances FDA’s authority to support emergency preparedness and response and foster the development and availability of medical products for use in these emergencies. 3 The provisions in PAHPRA, described in section II of this guidance, include key legal authorities to sustain and strengthen national preparedness for public health, military, and domestic emergencies involving chemical, biological, radiological, and nuclear (CBRN) agents, including emerging infectious disease threats such as pandemic influenza. This guidance explains FDA's general recommendations and procedures applicable to the authorization of the emergency use of certain medical products under sections 564, 564A, and 564B of the Federal Food, Drug, and Cosmetic Act 2 as amended or added by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). IMPORTING AND EXPORTING MEDICAL PRODUCTS UNDER AN EUAĪppendix A: EUA Conditions of Authorization: Required vs Discretionary REFERENCE INFORMATIONįDA offices that issued this guidance I. EMERGENCY USE INSTRUCTIONS WITHOUT AN EUA Duration of an Emergency Dispensing OrderĮ. Scope and Conditions of Emergency Dispensing Ordersģ. Procedures for Issuing Emergency Dispensing OrdersĢ. WAIVER OF CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS WITHOUT AN EUAġ. EXPIRATION DATE EXTENSIONS WITHOUT AN EUAĬ. EMERGENCY USE OF ELIGIBLE FDA-APPROVED MCMs WITHOUT AN EUAī. OPTION TO CARRY OUT AUTHORIZED ACTIVITIES CATEGORIZATION OF LABORATORY TESTS UNDER AN EUA Waivers or Limitations of Compliance With Other Requirementsį. Monitoring and Reporting of Adverse EventsĤ. Information Relating to the EUA ProductĢ. Determinations to Support an EUA Declarationġ. ![]() EUA DECLARATION JUSTIFYING EMERGENCY USEġ. ![]() Office of the Commissioner, Office of the Chief Scientist, Office of Counterterrorism and Emerging Threats Guidance for Industry and Other StakeholdersĬontents | Reference Information CONTENTSĪ.
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