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FDAAA 801 and the Final Rule
This page summarizes the clinical trial registration and results information submission requirements described in Section 801 of the Food and Drug Administration Amendments Act of 2007 (PDF), known as FDAAA 801. The statutory requirements have been in effect since September 27, 2007, have been codified at section 402(j) of the Public Health Service (PHS) Act, and include conforming amendments to the Federal Food, Drug, and Cosmetic FD&C Act (FD&C Act). The regulation became effective on January 18, 2017, and responsible parties have been required to be in compliance starting April 18, 2017.
This page also provides summary information about the Final Rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11). The Final Rule clarifies and expands the regulatory requirements and procedures for submitting registration and results information for certain trials to ClinicalTrials.gov, in accordance with FDAAA 801. The Final Rule has been in effect since January 18, 2017. For complete Final Rule requirements, please refer to 42 CFR Part 11. For additional information on the Final Rule, also see the Final Rule Information page and Frequently Asked Questions. To receive notifications when new information about the Final Rule is available, join the NIH FDAAA Update listserv.
For details about submitting information to ClinicalTrials.gov, see How to Register Your Study and How to Submit Your Results. For descriptions of data elements, see the documents provided in the Data Element Definitions, Templates, and Checklists section in Support Materials.
- Who Is Responsible for Registering Trials and Submitting Results?
- Which Trials Must Be Registered on ClinicalTrials.gov?
- When Do I Need to Register?
- Which Trials Must Have Results Information Submitted to ClinicalTrials.gov?
- When Do I Need to Submit Results Information?
- Are There Potential Legal Consequences If I Fail to Register or Submit Results?
- Other FDAAA 801 Requirements: NIH and FDA
Who Is Responsible for Registering Trials and Submitting Results?
The responsible party for an applicable clinical trial (ACT) must register the trial and submit results information. The responsible party is defined as:
- The sponsor of the clinical trial, as defined in 21 CFR 50.3; 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 the requirements for the submission of clinical trial information
Which Trials Must Be Registered on ClinicalTrials.gov?
Registration is required for studies that meet the definition of an "applicable clinical trial" (ACT) and either were initiated after September 27, 2007, or initiated on or before that date and were still ongoing as of December 26, 2007. ACTs, as defined in section 402(j) of the PHS Act, include the following:
- Controlled clinical investigations (other than phase 1 investigations) of any U.S. Food and Drug Administration (FDA)-regulated drug or biological product for any disease or condition
- Certain studies of FDA-regulated medical devices, excluding small clinical trials to determine feasibility and certain clinical trials to test prototype devices, but including FDA-required pediatric postmarket surveillances of a device product
As discussed in more detail in the Final Rule, and as reflected in 42 CFR 11.10, ACTs generally include interventional studies (with one or more arms) of FDA-regulated drug, biological, or device products 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, biological, or device product that is manufactured in the United States or its territories and is exported for research
Note: For ACTs studying a device product not previously approved or cleared by FDA for any use and that are required to be registered, full posting of the clinical trial information on ClinicalTrials.gov ordinarily is delayed until after the device product has been approved or cleared. See the Device Product Not Approved or Cleared by U.S. FDA data element on ClinicalTrials.gov. The Final Rule states that the responsible party may authorize the National Institutes of Health (NIH) to publicly post clinical trial registration information for an applicable device clinical trial of a device product that has not been previously approved or cleared by the U.S. FDA.
For complete statutory definitions and more information on the meaning of Applicable Clinical Trial, see the Checklist and Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT) ("ACT Checklist"), which follow the criteria specified in 42 CFR 11.22(b), to determine whether a study initiated on or after January 18, 2017, is an ACT subject to the expanded registration requirements under the Final Rule. Although the ACT Checklist and Elaboration document is intended for use with respect to determining the requirements for clinical trials or studies initiated on or after January 18, 2017, it may also be useful in evaluating whether a clinical trial or study that was initiated before January 18, 2017, is an ACT, even though such trials or studies are not subject to the expanded registration requirements in the Final Rule.
For more information, see the following frequently asked questions (FAQs):
- FAQs: See all FAQs related to applicable clinical trials
- 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 Surveillances of Device Products
Pediatric postmarket surveillances of device products ordered under Section 522 of the FD&C Act (PDF) as amended by Section 307 of FDAAA are considered ACTs and must be registered on ClinicalTrials.gov and have results information submitted.
Note: The remaining sections of this FDAAA 801 and the Final Rule page do not discuss requirements or exceptions for pediatric postmarket surveillances of device products.
See the relevant regulatory sections listed in the blue box below for more information.
Exclusions and Voluntary Submissions
The following types of studies are not subject to the registration and results submission requirements of section 402(j) of the PHS Act, including its implementing regulations (see the note below the bulleted list). Note that this is not a complete list.
- Phase 1 trials of investigational drug products or biological products, including studies in which investigational drug products are used as research tools to explore biological phenomena or disease processes (see the note below)
- Small clinical trials to determine the feasibility of a device product or a clinical trial to test prototype devices, where the primary outcome measure relates to feasibility and not to health outcomes (see the note below)
- Trials that do not include drug, biological, or device products, such as behavioral interventions
- Noninterventional (observational) clinical research, such as cohort studies
Note: If a responsible party voluntarily submits clinical trial information for a clinical trial that is not otherwise subject to the registration and results submission requirements, the responsible party may have to comply with certain requirements under section 402(j) of the PHS Act and its implementing regulations.
When Do I Need to Register?
The responsible party (that is, the sponsor or designated PI) for an ACT must submit the required clinical trial information no later than 21 days after enrollment of the first participant.
For ACTs that were 1) initiated on or before September 27, 2007, and 2) ongoing as of December 26, 2007, the following applies:
- Trials involving a "serious or life-threatening disease or condition" were required to have registration information submitted by December 26, 2007.
- Trials not involving a "serious or life-threatening disease or condition" were required to have registration information submitted by September 27, 2008.
See the statutory provision on data submission (PDF) and the following FAQs for more information.
- FAQ: Can I register a study after it has started, has closed to recruitment, or has been completed?
- FAQ: What registration information must I submit if my applicable clinical trial is required to be registered?
Which Trials Must Have Results Information Submitted to ClinicalTrials.gov?
Product Approved, Licensed, or Cleared as of the Primary Completion DateResults information submission is required for all ACTs of approved, licensed, or cleared products that reached their primary completion date after December 26, 2007. If the primary completion date was between December 27, 2007, and January 17, 2017, results information submission is required as specified in section 402(j)(3)(C) and section 402(j)(3)(I) of the PHS Act. If the primary completion date was on or after January 18, 2017, results information submission is required as specified in 42 CFR Part 11.
Product Not Approved, Licensed, or Cleared as of the Primary Completion DateFor ACTs of unapproved, unlicensed, or uncleared products that reached their primary completion date on or after January 18, 2017, results information submission is required as specified in 42 CFR Part 11. For ACTs of unapproved, unlicensed, or uncleared products that reached their primary completion date before January 18, 2017, results information submission is not required. See the following FAQ for more information:
When Do I Need to Submit Results Information?
In general, results information for an ACT subject to the results information submission requirements must be submitted by the responsible party no later than 12 months after the primary completion date.
See the statutory provision for completion date (PDF) and the following FAQ for more information:
- 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 Information
A responsible party may delay the submission of results information (see the note below the bulleted list) by submitting a certification that one of the two following conditions has been met:
Certify Initial Approval - The ACT reached its primary completion date on or after January 18, 2017, and before the drug, biological, or device product is initially approved, licensed, or cleared by FDA for any use (referred to on ClinicalTrials.gov as "certify initial approval").
(1) The earlier of the date that is 30 days after the date that:
- The drug, biological, or device product is approved, licensed, or cleared by FDA for any use that was studied in the ACT
- The application or premarket notification is withdrawn without resubmission for not less than 210 days
or (2) 2 years after the date that a certification is submitted, if neither of the events listed above has occurred by that time.
- Results deadline:
Certify New Use - The ACT studies a new use of an FDA-approved drug, biological, or device product (that is, a use not included in the labeling), and the manufacturer of the drug, biological, or device product 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").
(1) The earlier of the date that is 30 days after the date that:
- The new use of the drug, biological or device product is approved, licensed, or cleared by FDA;
- FDA issues a letter ending the regulatory review cycle for the application or submission for the new use of the drug, biological, or device product, such as a complete response letter, or
- The application or premarket notification for the new use is withdrawn without resubmission for no less than 210 days
or (2) 2 years after the date that a certification is submitted, if none of the events listed above has occurred by that time.
- Results deadline:
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 ACT that is required to be submitted in an application or premarket notification 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).
If the required clinical trial results information has not been collected for one or more secondary outcome measures or additional adverse event information by the primary completion date, the responsible party must submit the remaining required clinical trial results information by the deadlines specified in 42 CFR 11.44(d).
EXTENSIONS FOR GOOD CAUSE
The Director of the NIH may extend the deadline for submission of results information for an ACT if the responsible party submits a written request that demonstrates good cause for the extension and provides an estimated date on which the results information will be submitted. The Director will review and notify the responsible party as to whether the requested extension of the deadline for submitting results information demonstrates good cause and has been granted. Before this notification is issued, the processing of such requests by NIH does not mean that the NIH Director has determined the request demonstrates good cause. In general, pending publication would not be considered good cause for an extension.
See the statutory provision for Extensions (PDF) for more information.
Submitting a Certification for the Delayed Submission of Results Information or a Request for an Extension for Good Cause
A certification for the delayed submission of results information or request for an extension for good cause can be submitted via the Protocol Registration and Results System (PRS). Submission and processing of the request through the PRS in this manner facilitates the automated identification of trials that may not yet be required to submit results information.
The Final Rule describes a process by which the NIH Director reviews requests to extend the deadline for submitting results information and notifies responsible parties whether their request demonstrates good cause and has been granted. While the responsible party may submit a request for an extension via the PRS, the processing of such requests in the PRS does not mean that the NIH Director has determined that the request demonstrates good cause. More information about the extension request approval process will be made available soon on the Final Rule Information page.
Are There Potential Legal Consequences If I Fail to Register or Submit Results?
Section 801 of FDAAA amended the FD&C Act to authorize civil monetary penalties against responsible parties who fail to comply with registration and/or results submission requirements. In addition, in relation to federally funded studies, section 402(j)(5)(A) of the PHS Act provides for the withholding of remaining or future grant funds from a grantee for failure to submit clinical trial registration and results information.
See the statutory provisions regarding Civil Money Penalties (PDF) and Clinical Trials Supported by Grants From Federal Agencies (PDF).
For more information, see:
- FDA Draft Guidance - Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank (September 2018)
Other FDAAA 801 Requirements: NIH and FDA
NIH Certification Requirements
HHS agency grantees must certify that the responsible party has made all required registration and results submissions in their competing applications and noncompeting continuation progress reports for any NIH grant that supports an ACT, even if the grantee is not the responsible party. See section 402(j)(5)(A) of the PHS Act and 42 CFR 11.66(c).
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.
Certain drug, biological, and device product applications or submissions made to FDA must be accompanied by a certification of compliance indicating that the requirements of section 402(j) of the PHS Act, including any applicable provisions of the Final Rule, have been met.
Please refer to the following information from FDA to learn more about this requirement:
See the statutory provisions for Certification to Accompany Drug, Biological Product, and Device Submissions (PDF) for more information.
Informed Consent Regulations
FDA regulations at 21 CFR 50.25(c) require that the informed consent document for an ACT must include a specific statement regarding trial registration.
See the following for more information:
- Informed Consent Regulation at 21 CFR 50.25(c)
- Questions and Answers on Informed Consent Elements, 21 CFR 50.25(c) (PDF)
See the statutory provision requiring FDA to amend the informed consent regulations (PDF) for more information.
- 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 information on entering data in PRS.