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The device user facility reporting section of SMDA became effective on November 28, 1991. To implement SMDA, FDA published a tentative final rule in the Federal Register on November 26, 1991, inviting comments; over 300 comments were received. On June 16, 1992, the President signed into law the Medical Devices Amendments of 1992 (Public Law 102 ...
On January 20, 2026, the Food and Drug Administration's (FDA) new traceability rules — dubbed the Food Traceability Final Rule — will go into effect.
The U.S. congressional review concluded medical devices would require actual device experience in a clinical setting and sufficient reporting of adverse data events. The legislation would encompass medical devices demonstrating the potential for life-threatening events and accurate adverse data collection would be required for informed ...
It requires the FDA to work with states to assist in improving the safety of food. It requires a responsible person who determines that an article of food is a reportable food to submit a report to the FDA within 24 hours and to investigate the cause of the adulteration if the adulteration may have originated with the responsible person.
(Reuters) -The U.S. Food and Drug Administration (FDA) on Monday tightened regulations for clinical laboratories with a new rule that gives it more oversight of diagnostic tests developed by them.
These issues were made public in the hearings at the US Congress, which led to the FDA's publication of Proposed Regulations on GLP on November 19, 1976, [8] and establishment of the Final Rule in June 1979 [9] which became effective on June 20, 1979. [10] Proposed amendments were introduced on October 29, 1984. [11]
The United States Food and Drug Administration Modernization Acts (FDAMA) are amendments to the Federal Food, Drug, and Cosmetic Act, which regulated products by the FDA. The first bill, the FDA Modernization Act of 1997, reduced the timeline for approving new pharmaceutical drugs. It also loosened rules around broadcast pharmaceutical advertising.
Animal food manufacturers must implement current Good Manufacturing Practices and Preventive Controls.(Final rule published September 17, 2015) [22] Mandatory produce safety standards The FDA must establish science-based, minimum standards for the safe production and harvesting of fruits and vegetables.