U.S. Public Law 110-85
(Food and Drug Administration Amendments Act of 2007 or FDAAA), Title VIII, Section 801
mandates that a "responsible party" (i.e., the sponsor or designated principal investigator) register and
report results of certain "applicable clinical trials":
Trials of Drugs and Biologics: Controlled, clinical investigations, other than Phase I investigations, of a
product subject to FDA regulation;
Trials of Devices: Controlled trials with health outcomes of a product subject to FDA regulation
(other than small feasibility studies) and pediatric postmarket surveillance studies.
"Applicable clinical trials" generally include interventional studies (with
one or more arms) of drugs, biological products, or devices that are
subject to FDA regulation, meaning that the trial has one or more
sites in the U.S, involves a drug, biologic, or device that is
manufactured in the US (or its territories), or is conducted under an
investigational new drug application (IND).
For the complete statutory definitions and more detailed
information on the agency's current thinking about their meaning,
see this pdf document.
Statement on Pediatric Postmarket Surveillance of Devices -
Pediatric postmarket surveillance of devices ordered under section 522 of the
Federal Food, Drug and Cosmetic Act must be registered at ClinicalTrials.gov in
accordance with the provisions of Section 801 of FDAAA (see NIH Fact Sheet).
Please contact firstname.lastname@example.org to
determine the best mechanism for using ClinicalTrials.gov to address this provision.
Investigators or Sponsors who already have PRS accounts should log into the PRS for the latest information.
Others who anticipate needing to register studies in
ClinicalTrials.gov in accordance with the provisions of Section 801 of FDAAA should request a
PRS account using the instructions provided under Account Application Process.
Helpful hints (pdf)
- tips on entering results data, including three examples of common study models (parallel design, crossover design, and diagnostic
accuracy studies), reporting measure types, including information on reporting outcomes measured with a scale.