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FDAAA 801 Requirements
This page provides summary information on the clinical trial registration and results submission requirements described in Section 801 of the Food and Drug Administration Amendments Act (PDF), known as FDAAA 801. It includes information about the Responsible Party, Applicable Clinical Trials, deadlines for submitting required information, and penalties.
For details about the data submission process, see How to Register Your Study and How to Submit Your Results. For descriptions of data elements, see the Protocol Data Element Definitions and Basic Results Data Element Definitions.
- Who Is Responsible for Registering Trials and Submitting Results?
- Which Trials Must Be Registered and Have Results Submitted to ClinicalTrials.gov?
- When Do I Need to Register and Submit Results?
- Are There Penalties If I Fail to Register or Submit Results?
- Other FDAAA 801 Requirements: NIH and FDA
- Development of Regulations to Implement FDAAA 801
Who Is Responsible for Registering Trials and Submitting Results?
The Responsible Party for a clinical trial must register the trial and submit results information. The Responsible Party is defined as:
- The sponsor of the clinical trial or
- The principal investigator (PI) of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the PI is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of FDAAA's requirements for the submission of clinical trial information.
For complete statutory definitions and more information on the meaning of Responsible Party and sponsor, see the Elaboration of Definitions of Responsible Party and Applicable Clinical Trial (PDF) and the Responsible Party data element on ClinicalTrials.gov.
Which Trials Must Be Registered and Have Results Submitted to ClinicalTrials.gov?
Registration is required for trials that meet the FDAAA 801 definition of an "applicable clinical trial" and were either initiated after September 27, 2007, or initiated on or before that date and were still ongoing as of December 26, 2007. Trials that were ongoing as of September 27, 2007, and reached the Completion Date (see Primary Completion Date data element on ClinicalTrials.gov) before December 26, 2007, are excluded. Applicable Clinical Trials include the following:
- Trials of drugs and biologics: Controlled clinical investigations, other than phase 1 clinical investigations, of drugs or biological products subject to Food and Drug Administration (FDA) regulation
- Trials of devices (see note): 1) Controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and 2) pediatric postmarket surveillance required by FDA
Applicable Clinical Trials generally include interventional studies (with one or more arms) of FDA-regulated drugs, biological products, or devices that meet one of the following conditions:
- The trial has one or more sites in the United States
- The trial is conducted under an FDA investigational new drug application or investigational device exemption
- The trial involves a drug, biologic, or device that is manufactured in the United States or its territories and is exported for research
Note: For Applicable Clinical Trials that include a device not previously approved or cleared by FDA for any use and that need to be registered, full posting of the trial information on ClinicalTrails.gov will be delayed until after the device has been approved or cleared, as required by FDAAA 801. See the Delayed Posting data element on ClinicalTrials.gov.
For complete statutory definitions and more information on the meaning of Applicable Clinical Trial, see Elaboration of Definitions of Responsible Party and Applicable Clinical Trial (PDF).
- FAQ: Does FDAAA 801 only apply to Industry-sponsored studies?
- FAQ: Does the definition of Applicable Clinical Trial under FDAAA 801 only include studies conducted under an FDA Investigational New Drug Application (IND) or Investigational Device Exemption (IDE)?
Pediatric Postmarket Surveillance of Devices
Pediatric postmarket surveillance of devices ordered under Section 522 of the Federal Food, Drug, and Cosmetic Act (PDF) as amended by Section 307 of FDAAA are considered Applicable Clinical Trials and must be registered on ClinicalTrials.gov and have results information submitted. Please contact firstname.lastname@example.org to determine how to meet this requirement.
The following types of studies are generally excluded from the registration and results submission requirements of FDAAA 801 (see note). This is not a complete list.
- Phase 1 drug trials, including studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes (see note)
- Small clinical trials to determine the feasibility of a device or a clinical trial to test prototype devices, where the primary outcome measure relates to feasibility and not to health outcomes (see note)
- Trials that do not include drugs, biologics, or devices (such as behavioral interventions)
- Noninterventional (observational) clinical research (such as cohort or case-control studies)
- Trials that were ongoing as of September 27, 2007, and reached the Completion Date (see Primary Completion Date data element on ClinicalTrials.gov) before December 26, 2007 (see note)
Note: Trial may be subject to the Voluntary Submissions provision of FDAAA 801. See the statutory provision for Voluntary Submissions (PDF) for more information.
Results submission is required for Applicable Clinical Trials that were required to be registered under FDAAA 801 and that study drugs, biologics, or devices that are approved, licensed, or cleared by FDA.
When Do I Need to Register and Submit Results?
The Responsible Party (that is, the sponsor or designated PI) for an Applicable Clinical Trial must submit the required clinical trial information no later than 21 days after enrollment of the first participant.
- Trials involving a "serious or life-threatening disease or condition" should have been submitted by December 26, 2007.
- Trials not involving a "serious or life-threatening disease or condition" should have been submitted by September 27, 2008.
See the statutory provision on Data Submission (PDF) for more information.
In general, results of an Applicable Clinical Trial of a drug, biologic, or device that is approved, licensed, or cleared by FDA must be submitted by the Responsible Party no later than 12 months after the Completion Date (see Primary Completion Date data element on ClinicalTrials.gov).
See the statutory provision of Completion Date (PDF).
- FAQ: How do I submit results information if the trial is terminated (that is, stopped prematurely) and no data were collected for one or more Outcome Measures?
Delayed Submission of Results
A Responsible Party may delay the submission of results until the deadlines described below by submitting a certification (see note) that an Applicable Clinical Trial meets either of the following conditions:
- The trial reached its Completion Date
(see Primary Completion Date data element)
before the drug, biologic, or device is initially approved, licensed, or cleared by FDA for any use
(referred to on ClinicalTrials.gov as "certify initial approval").
- Results Deadline: No later than 30 days after the drug or device is approved, licensed or cleared by the FDA
- The trial studies a new use of an FDA-approved drug, biologic, or device (that is, a use not included in the labeling), and the manufacturer of the drug, biologic, or device is the sponsor of the trial and
has filed or will file within 1 year an application to FDA for approval or clearance of that use (referred to on ClinicalTrials.gov as "certify new use").
- Results Deadline: 1) The earlier of the date that is 30 days after the date that:
- The new use of the drug or device is approved, licensed, or cleared by FDA
- FDA issues a letter for the new use of the drug or device, such as a complete response letter
- The application or premarket notification for the new use is withdrawn without resubmission for no less than 210 days
- Results Deadline: 1) The earlier of the date that is 30 days after the date that:
Note: If a Responsible Party that is both the sponsor and the manufacturer submits a new use certification, this certification must be made with respect to each Applicable Clinical Trial that is required to be submitted in an application or report for licensure, approval, or clearance of the use studied in the clinical trial.
See the statutory provision for Delayed Submission of Results With Certification (PDF).
The Director of the National Institutes of Health (NIH) may extend the deadline for submission of results information for an Applicable Clinical Trial if the Responsible Party submits a written request that demonstrates good cause for the extension and provides an estimate of the date on which the results information will be submitted. Pending publication is not considered good cause for an extension.
See the statutory provision for Extensions (PDF) for more information.
Submitting a Certification or Request for Extension for Delayed Submission of Results
A certification or request for extension is submitted via the Protocol Registration and Results System (PRS). A trial must have a ClinicalTrials.gov Identifier (NCT Number) prior to submission of a certification or request for extension. Submission of this certification will facilitate automated identification of trials that are not yet required to submit results.
Are There Penalties If I Fail to Register or Submit Results?
FDAAA 801 establishes penalties for Responsible Parties who fail to comply with registration or results submission requirements. Penalties include civil monetary penalties and, for federally funded studies, the withholding of grant funds.
See the statutory provisions amending Civil Money Penalties (PDF) and Clinical Trials Supported by Grants From Federal Agencies (PDF) for more information.
Other FDAAA 801 Requirements: NIH and FDA
NIH and FDA have two separate certification requirements. NIH grantees must certify compliance with FDAAA 801 in their competing applications and noncompeting continuation progress reports for any NIH grant that supports an Applicable Clinical Trial, even if the grantee is not the Responsible Party. An application/submission to FDA for a drug, biological product, or device must be accompanied by a certification indicating that the requirements of FDAAA 801 have been met. In addition, informed consent for Applicable Clinical Trials subject to FDA's Protection of Human Subjects regulation (Title 21, Part 50) must include a specific statement about trial registration.
Please refer to the following grants policy information from NIH's Office of Extramural Research to learn more about ensuring compliance with NIH's implementation of FDAAA 801:
See the statutory provisions for Clinical Trials Supported by Grants From Federal Agencies (PDF) for more information.
Certification of Compliance
FDAAA 801 requires that the following certification form accompany certain human drug, biological, and device product applications/submissions to FDA:
For more information, please refer to the following FDA guidance:
See the statutory provision for Certification To Accompany Drug, Biological Product, and Device Submissions (PDF) for more information.
Informed Consent Regulations
In accordance with FDAAA 801, FDA published a final rule to amend the informed consent regulations of Title 21, Part 50 (Protection of Human Subjects) of the Code of Federal Regulations. The final rule requires a statement in informed consent for Applicable Clinical Trials regarding the availability of clinical trial information on ClinicalTrials.gov. See the following:
For more information, please refer to the following FDA guidance:
See the statutory provision requiring FDA to amend the informed consent regulations (PDF) for more information.
Development of Regulations to Implement FDAAA 801
In November 2014, the US Department of Health and Human Services issued a notice of proposed rulemaking (NPRM) describing the proposed requirements and procedures for registering and submitting the results, including adverse events, of clinical trials on ClinicalTrials.gov, in accordance with FDAAA 801. It also considers regulations intended to provide more complete results information and to enhance patients' access to the results of clinical trials, by proposing to expand the requirement for submission of results information for Applicable Clinical Trials of unapproved products (i.e., drugs, biological products, or devices that have not been approved, licensed, or cleared by FDA). Public comments on the proposed rule can be submitted until February 19, 2015. All substantive comments will be carefully reviewed and considered in drafting a final rule.
Note: The NPRM does not change the current requirements; instead it is a proposal that is being issued for public comment to inform any future changes to requirements that will be implemented in a final rule.
- NIH News Release: HHS and NIH take steps to enhance transparency of clinical trial results (November 19, 2014)
- Office of the Federal Register: Clinical Trials Registration and Results Submission Notice of Proposed Rulemaking (November 2014)
- Reginfo.gov: U.S. Department of Health and Human Services Unified Agenda - Clinical Trials Registration and Results Submission (RIN:0925-AA55). Describes the public process for the expansion of ClinicalTrials.gov under Section 801 of FDAAA.
Topics considered in the NPRM were discussed at a public meeting held at the NIH in April 2009.For additional information on the public meeting, see History, Policies, and Laws on ClinicalTrials.gov.
To receive occasional announcements containing information about FDAAA 801 (U.S. Public Law 110-85), join the NIH FDAAA Update listserv.
- History of ClinicalTrials.gov: See History, Policies, and Laws for information on the development of ClinicalTrials.gov as a result of changing legislation.
- Help with entering clinical study data: See How to Register Your Study and How to Submit Your Results for detailed guidance on entering data in PRS.
- Online presentations:
Overview of ClinicalTrials.gov
Deborah A. Zarin, M.D., Director, ClinicalTrials.gov, National Library of Medicine (NLM)
Provides an overview of the reasons for registering studies and submitting results, a history of ClinicalTrials.gov, and information on the data submission and review processes
Key FDAAA Issues
Deborah A. Zarin, M.D., Director, ClinicalTrials.gov, NLM
Discusses key issues in the FDAAA related to registering trials and submitting results
- Overview of ClinicalTrials.gov (28:44)