|  | Public Health Safety | Food Safety

FDA Data Standards

The Food and Drug Administration (FDA) is responsible for ensuring that food and drug products meet federal health and safety standards. In order to facilitate the sharing of data within the FDA and between similar organizations, the FDA Data Standards Council has adopted a set of standards governing study data and stability data.

  1. Council

    • The FDA Data Standards Council is responsible for the development, evaluation, adoption and maintenance of health and regulatory data standards. This is to ensure that common data standards are used throughout the entire agency.

    Standards

    • Study data standards are in place so FDA researchers can easily exchange data and reports. Four categories of study data standards exist: the study design standard, the study participation standard, the subject data standard and the individual case study report standard.

    Stability Data

    • Stability data provides information about whether a particular food or drug product is of acceptable quality throughout its entire shelf life. The stability standard used by the FDA is called Health Level Seven (HL7). According to the FDA, the HL7 was adopted due in part to the fact that it is based in XML, a common way of encoding documents in machine-readable form.

Food Safety - Related Articles