We hope that this report will put a face on the children who benefit every
day from medical devices, lend a voice to some of the challenges they face in
realizing the benefits of the devices, and give heart to those who want to make
things even better. In spirit, our report is for these children and their families.
As written, this report responds to a request from Congress to investigate
the questions described in the Summary and Chapter 1, and we have
aimed much of our analysis and recommendations at legislative and administrative
policymakers and those who advise them.
The task for the Committee on Use of Dietary Reference Intakes
in Nutrition Labeling, which I was privileged to chair, was to provide
guidance to the U.S. Department of Health and Human Services’
Food and Drug Administration (FDA), the U.S. Department of Agriculture’s
Food Safety and Inspection Service (FSIS), and Health
Canada on how to use the Dietary Reference Intakes (DRIs) to
update the nutrient reference values used in nutrition labeling.
The U.S. FDA CGMP request in section 211.165 (e) methods to be validated: The
accuracy, sensitivity, specificity, and reproducibility of test methods employed by the
firm shall be established and documented. Such validation and documentation may be
accomplished in accordance with Sec. 211.194(a). These requirements include a
statement of each method used in testing the sample to meet proper standards of
accuracy and reliability, as applied to the tested product. The U.S. FDA has also
proposed industry guidance for Analytical Procedures and Methods Validation....