H.R. 2425

This bill amends the Federal Food, Drug, and Cosmetic Act to allow a person to request that the Food and Drug Administration (FDA) recognize all or part of a performance standard established by a nationally or internationally recognized standard organization as a standard to which a medical device may conform in order to meet an FDA requirement. When a request to recognize a standard is received, the FDA must determine whether to recognize all, part, or none of the standard and publish the rationale for that determination. (Currently, the FDA recognizes certain performance standards, but it is not required to respond to requests or publish rationales for recognizing standards.)

The FDA must: (1) publish the rationale for recognizing only part of a standard, (2) periodically train employees who review premarket submissions for medical devices on the concept and use of recognized standards for purposes of meeting requirements, and (3) publish its principles for recognizing standards.