Medical Devices; Draft Guidance on Evidence Models for the Least Burdensome Means to Market; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Evidence Models for the Least Burdensome Means to Market.'' This draft guidance is intended to provide guidance to the medical device industry and FDA reviewers on implementing section 205 of the Food and Drug Administration Modernization Act of 1997 (FDAMA). Section 205 requires FDA, in consultation with the product sponsor, to consider the ``least burdensome'' means that will allow appropriate premarket development and review of a product without unnecessary delays and expense to manufacturers. This draft guidance represents the agency's current thinking on implementing section 205 of FDAMA, and it is neither final nor is it in effect at this time.