This bill amends the Federal Food, Drug, and Cosmetic Act to require Food and Drug Administration (FDA) employees involved in reviewing premarket submissions of medical devices to receive training regarding the "least burdensome appropriate means" concept. (Currently, the FDA must consider evaluating medical devices by the least burdensome appropriate means that would have a reasonable likelihood of resulting in approval.) The ombudsman for the FDA unit responsible for the premarket review of devices must audit this training and include in the audit interviews with persons from industry regarding their experience in the device premarket review process.
When the FDA requests additional information about a medical device that is required to have premarket approval, it must consider the least burdensome appropriate means necessary for an applicant to demonstrate the safety and effectiveness of the device.
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