Guidance for Industry: General/Specific Intended Use (for Medical Devices)

摘要

This guidance document identifies the general principles that will be considered211u001eby the Food and Drug Administration (FDA) in determining when a specific 211u001eindication for use is reasonably included within a general indication for use of 211u001ea medical device for purposes of determining substantial equivalence under 211u001eSection 513(f) or Section 520(1) of the Federal Food, Drug and Cosmetic Act (the 211u001eAct). This guidance is issued in accordance with new Section 513(1)(1)(F) of the 211u001eAct, which was added by Section 206 of the Food and Drug Administration 211u001eModernization Act of 1997 (FDAMA). There are a number of reasons medical device 211u001emanufacturers may seek to add a specific indication for use to a general use of a 211u001elegally marketed predicate device. In some cases, technology may drive a 211u001emanufacturer's decision to request the addition of a specific indication for use; 211u001e'minor' technological changes to a device may make it more applicable to one 211u001especific indication for use and less applicable to other uses.