Results submission is not required under FDAAA 801 for a clinical trial that is not an Applicable Clinical Trial (for example, a phase 1 trial studying an FDA-regulated investigational new drug). If a Responsible Party chooses to voluntarily submit results for such a trial, however, the Voluntary Submissions (PDF) provision of FDAAA 801 may apply. Under the Voluntary Submissions (PDF) provision, a Responsible Party who submits results for such a clinical trial must submit complete clinical trial results information and must also submit results for each Applicable Clinical Trial that is required to be submitted to FDA under Sections 505, 510(k), 515, and 520(m) of the Federal Food, Drug, and Cosmetic Act or Section 351 of the Public Health Service Act for the same use studied.
