This bill amends the Federal Food, Drug, and Cosmetic Act to define “valid scientific evidence” to include well-documented case histories or studies published in peer-reviewed journals for purposes of the Food and Drug Administration (FDA) determining the effectiveness of a medical device without clinical investigation. Under specified conditions, the FDA may request the data underlying a study that is offered as valid scientific evidence.
| Action Date | Type | Text | Source |
|---|---|---|---|
| 2015-05-22 | Committee | Referred to the Subcommittee on Health. | House committee actions |
| 2015-05-19 | IntroReferral | Referred to the House Committee on Energy and Commerce. | House floor actions |
| 2015-05-19 | IntroReferral | Introduced in House | Library of Congress |