FDA Modernization Act of 1997: modifications to the list of recognized standards; availability; withdrawal of draft guidance "Use of IEC 60601 standards; medical electrical equipment"--FDA. Notice.
The Food and Drug Administration (FDA) is announcing the publication of the modifications to the list of standards that will be recognized for use in the premarket review process and withdrawing its draft guidance entitled "Use of IEC 60601 Standards; Medical Electrical Equipment." This will assist manufacturers who elect to declare conformity with consensus standards to meet all or part of medical device review requirements.
D018795:Device Approval / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration