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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.
The Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11), which clarifies and expands the requirements in FDAAA 801, was released in September 2016. For additional information on the requirements of the final rule, see Regulations Implementing FDAAA 801.
For details about the ClinicalTrials.gov data submission process, see How to Register Your Study and How to Submit Your Results. For descriptions of data elements, see the Protocol Registration Data Element Definitions, Expanded Access Data Element Definitions, and 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
- Regulations Implementing 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 ClinicalTrials.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 email@example.com 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 for 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").
- 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 additional certification and informed consent 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.
NIH Certification Requirements
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 provision for Clinical Trials Supported by Grants From Federal Agencies (PDF) for more information.
Please refer to the following information from FDA to learn more about: (1) the certification form required to accompany certain applications/submissions to FDA and (2) the statement required to be included in informed consent regarding the availability of clinical trial information on ClincialTrials.gov for Applicable Clinical Trials:
See the statutory provisions 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 Protection of Human Subjects (Title 21, Part 50) 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.
Regulations Implementing FDAAA 801
In September 2016, the U.S. Department of Health and Human Services issued a final rule that clarifies and expands the regulatory requirements and procedures for submitting registration and summary results information of clinical trials on ClinicalTrials.gov, in accordance with FDAAA 801. The final rule is intended to make it clear to sponsors, investigators, and the public which trials must be submitted, when they must be submitted, and whether compliance has been achieved. For example, the final rule clarifies the definition of an applicable clinical trial and provides structured criteria for determining which studies meet the definition. The final rule also expands the FDAAA 801 requirements by requiring the submission of results information for trials of unapproved products. The regulation is effective on January 18, 2017 and responsible parties are expected to be in compliance as of April 18, 2017.
Office of the Federal Register: Final Rule for Clinical Trials Registration and Results Information Submission
- NIH: Changes from Current Practice Described in the Final Rule (PDF) (December 2016)
NIH News Release: HHS takes steps to provide more information about clinical trials to the public (September 16, 2016)
- Zarin DA, Tse T, Williams RJ, Carr S. Trial reporting in ClinicalTrials.gov - the final rule. N Engl J Med. 2016 Nov 17;375(20):1998-2004. [Full Text]
- Hudson KL, Lauer MS, Collins FS. Toward a new era of trust and transparency in clinical trials. JAMA; 2016 Oct4;316(13):1353-1354. [Full Text]
- Final Rule Information: View general information about the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11).
- Final Rule Webinar Series: View the archived content for the webinar series, designed to assist responsible parties further their understanding of the final rule.
- NIH: Checklist and Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (PDF) (December 2016)
- Frequently Asked Questions (FAQs): View FAQs about the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11).
To receive notifications when new information about the final rule is available, 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.