Zdrowie i gospodarka · 22/05/1998

Guidance for Industry on General/Specific Intended Use; Draft; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Guidance for Industry on General/Specific Intended Use.'' This draft guidance is not final or in effect at this time. The purpose of this draft guidance is to help medical device manufacturers understand the principles used by FDA to determine whether the addition of a specific indication for use to a medical device cleared for marketing with a general indication for use could trigger the need for a premarket approval application (PMA). The draft guidance is intended to help manufacturers answer the following questions: Under what circumstances is a device with a new, specific indication for use likely to be found to be substantially equivalent to a device legally marketed for a general indication for use? Conversely, when does a specific indication for use become a new intended use that requires submission of a PMA to establish the safety and effectiveness of the device?