FDA Clarifies Its Evaluations for Intended Use

The FDA has explained in a new proposed rule how it determines whether products are intended for use as drugs or devices and how it decides if approved products are intended for a new use.

The agency noted that companies have expressed concern that the current intended-use regulations could be interpreted to mean that a firm’s mere knowledge of an unapproved use of its product automatically triggers requirements for new labeling. That’s not the case, the FDA said.

The agency said it “generally does not seek to interfere with the exercise of the professional judgment of healthcare providers in prescribing or using, for unapproved uses for individual patients, most legally marketed medical products. This longstanding position has been codified with respect to devices [in 21 U.S. Code 396 on Practice of Medicine].”