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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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8-2 - INTRODUCTION

 8-2 - INTRODUCTION
      8-2-1 - Policy

  8-2 - INTRODUCTION

  8-2-1 - Policy

These procedures provide guidance for the agency to act immediately to protect the public from contaminated or defective FDA-regulated products or in situations when FDA-regulated products need to be utilized or deployed. Prompt emergency actions are dependent upon the expeditious reporting and investigation of significant incidents or complaints relating to FDA-regulated products. Examples of such incidents include chemical and biological terrorism, chemical spills affecting food and animal feed supplies, natural disasters, radiological incidents, and food-borne illness outbreaks.

The emergency alert system which is a part of this procedure directs telephone notification to the FDA Emergency Operations Center (EOC), HFA-615, Office of Crisis Management, Office of the Commissioner. This alert system utilizes information from many internal FDA sources (e.g., consumer complaint systems, adverse reactions, product defect, radiological release and other surveillance reporting systems). The EOC also receives information from outside sources, including other federal or state agencies, foreign health officials, industry and the press.

The FDA conducts response operations under the Incident Command System (ICS).  The EOC coordinates the FDA response to emergency situations by facilitating rapid and early information sharing as well as providing real-time situational awareness to and from FDA Headquarters, Centers, and Field Offices. The EOC is supported by a multi-level network of over 40 FDA Headquarters, Center, Regional, and District Offices.

  1. Definition Of Emergency
    For the purpose of this procedure, the following dictionary definition of "emergency" shall apply:

    "An unforeseen combination of circumstances, or the resulting state, that calls for immediate actions."

  2. This Procedure Was Developed To Provide Guidance For Planning, Monitoring, Coordinating, And Directing FDA Response To:
    1. national emergencies (e.g., civil disorders; major transportation and industrial strikes; acts of terrorism; refugee crises; etc.);
    2. natural disasters (e.g., hurricanes; floods; earthquakes; tornadoes; volcanic eruptions; etc.);
    3. man-made disasters (e.g., radiological incidents; chemical spills; toxic waste problems; air pollution problems; etc.);
    4. injury and illness complaints or reports of tampering (e.g., foods; drugs; biologics; cosmetics; medical, and radiation emitting devices; veterinary products;
    5. epidemiological investigations (e.g., illness outbreaks associated with foodborne or other pathogens and adverse reactions, etc.); and,
    6. agency emergency preparedness (e.g., planning, development, implementation, and testing of emergency preparedness plans in response to attack).
  3. Relationship To Recalls
    Product recalls may occur during an emergency investigation; if so, procedures under Chapter 7 of this manual should be followed as well. A recall of a defective product which is progressing satisfactorily will not by itself activate this procedure.