Zdrowie i gospodarka · 11/10/1995

International Harmonization; Policy on Standards

The Food and Drug Administration (FDA) is announcing the agency's policy on the development and use of standards with respect to international harmonization of regulatory requirements and guidelines. Specifically, the policy is intended to address the conditions under which FDA plans to participate with standards bodies outside of FDA, domestic or international, in the development of standards applicable to products regulated by FDA. The policy also covers the conditions under which FDA intends to use the resultant standards, or other available domestic or international standards, in fulfilling its statutory mandates for safeguarding the public health.