[1] The U.S. legislation was signed by Bill Clinton on 21 November 1997,[2] and fully enacted by 1 April 1999,[3] putting into law reforms begun under the National Partnership for Reinventing Government.

The initiatives include measures to modernize the regulation of biological products by bringing them in harmony with the regulations for drugs and eliminating the need for establishment license application; eliminate the batch certification and monograph requirements for insulin and antibiotics; streamline the approval processes for drug and biological manufacturing changes; and reduce the need for environmental assessment as part of a product application.

The act allows a firm to circulate peer-reviewed journal articles about an off-label indication of its product, providing the company is also committing itself to file proof of research within a certain amount of time.

Finally, the law expands an ongoing pilot program under which the FDA accredits outside—so-called "third party"—experts to conduct the initial review of all low-to-intermediate risk class I and II devices.

The act, however, specifies that an accredited person may not review devices that are permanently implantable, life-supporting, life sustaining, or for which clinical data are required.

[8] In the area of drugs, the law codifies the agency's current practice of allowing in certain circumstances one clinical investigation as the basis for product approval.

In the area of medical devices, the act specifies that the FDA may keep out of the market products whose manufacturing processes are so deficient that they could present a serious health hazard.