21 cfr 801

21 cfr 801 DEFAULT

Title 21 United States Code (USC) Controlled Substances Act

21 U.S.C.
United States Code, 2016 Edition
Title 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
From the U.S. Government Printing Office, www.gpo.gov

SUBCHAPTER I — CONTROL AND ENFORCEMENT

Part A — Introductory Provisions

Section 801. Congressional findings and declarations: controlled substances

Section 801a. Congressional findings and declarations: psychotropic substances

Section 802. Definitions

Section 803. Repealed

Part B — Authority to Control; Standards and Schedules

Section 811. Authority and criteria for classification of substances

Section 812. Schedules of controlled substances

Section 813. Treatment of controlled substance analogues

Section 814. Removal of exemption of certain drugs

Part C — Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances

Section 821. Rules and regulations

Section 822. Persons required to register

Section 822a. Prescription drug take back expansion

Section 823. Registration requirements

Section 824. Denial, revocation, or suspension of registration

Section 825. Labeling and packaging

Section 826. Production quotas for controlled substances

Section 826a. Attorney General report on drug shortages

Section 827. Records and reports of registrants

Section 828. Order forms

Section 829. Prescriptions

Section 829a. Delivery of a controlled substance by a pharmacy to an administering practitioner

Section 830. Regulation of listed chemicals and certain machines

Section 831. Additional requirements relating to online pharmacies and telemedicine

Section 832. Suspicious orders

Part D — Offenses and Penalties

Section 841. Prohibited acts A

Section 842. Prohibited acts B

Section 843. Prohibited acts C

Section 844. Penalties for simple possession

Section 844a. Civil penalty for possession of small amounts of certain controlled substances

Sections 845 to 845b. Transferred

Section 846. Attempt and conspiracy

Section 847. Additional penalties

Section 848. Continuing criminal enterprise

Section 849. Transportation safety offenses

Section 850. Information for sentencing

Section 851. Proceedings to establish prior convictions

Section 852. Application of treaties and other international agreements

Section 853. Criminal forfeitures

Section 853a. Transferred

Section 854. Investment of illicit drug profits

Section 855. Alternative fine

Section 856. Maintaining drug-involved premises

Section 857. Repealed

Section 858. Endangering human life while illegally manufacturing controlled substance

Section 859. Distribution to persons under age twenty-one

Section 860. Distribution or manufacturing in or near schools and colleges

Section 860a. Consecutive sentence for manufacturing or distributing, or possessing with intent to manufacture or distribute, methamphetamine on premises where children are present or reside

Section 861. Employment or use of persons under 18 years of age in drug operations

Section 862. Denial of Federal benefits to drug traffickers and possessors

Section 862a. Denial of assistance and benefits for certain drug-related convictions

Section 862b. Sanctioning for testing positive for controlled substances

Section 863. Drug paraphernalia

Section 864. Anhydrous ammonia

Section 864a. Grants to reduce production of methamphetamines from anhydrous ammonia

Section 865. Smuggling methamphetamine or methamphetamine precursor chemicals into the United States while using facilitated entry programs

Part E — Administrative and Enforcement Provisions

Section 871. Attorney General

Section 871a. Semiannual reports to Congress

Section 872. Education and research programs of Attorney General

Section 872a. Public-private education program

Section 873. Cooperative arrangements

Section 874. Advisory committees

Section 875. Administrative hearings

Section 876. Subpenas

Section 877. Judicial review

Section 878. Powers of enforcement personnel

Section 879. Search warrants

Section 880. Administrative inspections and warrants

Section 881. Forfeitures

Sections 881–1, 881a. Transferred

Section 882. Injunctions

Section 883. Enforcement proceedings

Section 884. Immunity and privilege

Section 885. Burden of proof; liabilities

Section 886. Payments and advances

Section 886a. Diversion Control Fee Account

Section 887. Coordination and consolidation of post-seizure administration

Section 888. Repealed

Section 889. Production control of controlled substances

Section 890. Review of Federal sales of chemicals usable to manufacture controlled substances

Part F — General Provisions

Codification

The letter designation for this Part F was, in the original, Part G. The original Part F of title II of Pub. L. 91–513, consisting of section 601 thereof, is set out as a note under section 801 of this title. The original Part G of title II of Pub. L. 91–513 consisted of sections 701 to 709. Sections 701 to 705 amended and repealed sections in this title and in Title 18, Crimes and Criminal Procedure, and Title 42, The Public Health and Welfare, and enacted provisions set out as notes under sections 321, 801, and 822 of this title. See Tables for classifications of said sections 701 to 705. Sections 706 to 709 of Pub. L. 91–513 are set out as sections 901 to 904 of this title and, for purposes of codification, comprise this Part F.

Section 901. Severability

Section 902. Savings provisions

Section 903. Application of State law

Section 904. Payment of tort claims

SUBCHAPTER II — IMPORT AND EXPORT

Codification

This subchapter is comprised of Part A of title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part B of title III contains amendatory, repealing, and transitional provisions generally classified elsewhere.

Section 951. Definitions

Section 952. Importation of controlled substances

Section 953. Exportation of controlled substances

Section 954. Transshipment and in-transit shipment of controlled substances

Section 955. Possession on board vessels, etc., arriving in or departing from United States

Section 955a to 955d. Transferred

Section 956. Exemption authority

Section 957. Persons required to register

Section 958. Registration requirements

Section 959. Possession, manufacture, or distribution of controlled substance

Section 960. Prohibited acts A

Section 960a. Foreign terrorist organizations, terrorist persons and groups

Section 961. Prohibited acts B

Section 962. Second or subsequent offenses

Section 963. Attempt and conspiracy

Section 964. Additional penalties

Section 965. Applicability of part E of subchapter I

Section 966. Authority of Secretary of the Treasury

Section 967. Smuggling of controlled substances; investigations; oaths; subpenas; witnesses; evidence; production of records; territorial limits; fees and mileage of witnesses

Section 968. Service of subpena; proof of service

Section 969. Contempt proceedings

Section 970. Criminal forfeitures

Section 971. Notification, suspension of shipment, and penalties with respect to importation and exportation of listed chemicals

NOTICE: This is an unofficial version. An official version of this publication may be obtained directly from the Government Publishing Office (GPO).

Sours: https://www.deadiversion.usdoj.gov/21cfr/21usc/

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. Receive notifications when new information is added by subscribing to the ClinicalTrials.gov Hot Off the PRS! email bulletin.

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.

Contents

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
Regulations (42 CFR Part 11)

The final rule specifies that there must be one (and only one) responsible party for purposes of submitting information about an applicable clinical trial. The sponsor of an applicable clinical trial will be considered the responsible party, unless and until the sponsor designates a qualified principal investigator as the responsible party. This final rule specifies the approach for determining who will be considered the sponsor of an applicable clinical trial under various conditions, what qualifies a principal investigator to be designated a responsible party by a sponsor, and how responsibility reverts to the sponsor if a designated principal investigator is unable to fulfill the requirements for submitting information to ClinicalTrials.gov unless and until the sponsor designates another principal investigator as the responsible party (42 CFR Part 11). For more information, see 81 FR 64982.

Key regulatory provisions and related discussions in the Final Rule (81 FR 64982) include:

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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

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):

Regulations (42 CFR Part 11)

Overall, the final rule clarifies which clinical trials of FDA-regulated drug products (including biological products) and device products and which pediatric postmarket surveillances of a device product, are applicable clinical trials for which information must be submitted to ClinicalTrials.gov. The final rule considers all clinical trials with one or more arms and with one or more pre-specified outcome measures to be controlled clinical trials. The final rule explains that we have determined that no expanded access use would be considered an applicable clinical trial under section 402(j) of the PHS Act. The final rule also describes an approach for evaluating, prior to registration, whether a particular clinical trial or study is an applicable clinical trial. [81 FR 64982] For more information on regulatory requirements, see 42 CFR Part 11. For additional information on evaluating whether a study is an applicable clinical trial, see the Checklist and Elaboration for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT) (PDF).

Key regulatory provisions and related discussions in the Final Rule (81 FR 64981) include:

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.

Regulations (42 CFR Part 11)

Key regulatory provisions and related discussions in the Final Rule (81 FR 64981) include:

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.


Regulations (42 CFR Part 11)

For information on regulatory requirements, see 42 CFR Part 11. In particular, see:

  • 42 CFR 11.60 What requirements apply to the voluntary submission of clinical trial information for clinical trials of FDA-regulated drug products (including biological products) and device products? (see Sec. IV.D.1 of the Final Rule for discussion)

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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.

Exceptions

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.

Regulations (42 CFR Part 11)

Overall, the final rule specifies requirements for registering applicable clinical trials at ClinicalTrials.gov. It requires that the responsible party register an applicable clinical trial not later than 21 calendar days after enrolling the first human subject (also referred to as participant or subject) (81 FR 64982).

For information on regulatory requirements, see 42 CFR Part 11. In particular, see:

  • 42 CFR 11.24 When must clinical trial registration information be submitted? (see Sec. IV.B.3 of the Final Rule for discussion)

Which Trials Must Have Results Information Submitted to ClinicalTrials.gov?

Product Approved, Licensed, or Cleared as of the Primary Completion Date

Results information submission is required for all ACTs of approved, licensed, or cleared products that reach 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 sections 402(j)(3)(C) and 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 Date

For 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 with a primary completion date before January 18, 2017, which studied products that were unapproved, unlicensed, or uncleared when the ACTs reached their primary completion date but are subsequently approved, licensed, or cleared, the responsible party must submit the results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the PHS Act not later than 30 days after product is approved, licensed, or cleared by FDA. See the following FAQ for more information:

Regulations (42 CFR Part 11)

The final rule addresses the statutory requirement for the submission of summary results information for applicable clinical trials of drug products (including biological products) and device products that are approved, licensed, or cleared by FDA. It also extends the requirement for results information submission to applicable clinical trials of drug products (including biological products) and device products that are not approved, licensed, or cleared by FDA. The rule requires the submission of data in a tabular format summarizing participant flow; demographic and baseline characteristics; primary and secondary outcomes, as well as results of any scientifically appropriate statistical tests; and adverse event information. In addition, the rule requires the submission of the full protocol and statistical analysis plan (if a separate document) (81 FR 64983).

For information on regulatory requirements, see 42 CFR Part 11. In particular, see:

  • 42 CFR 11.42 For which applicable clinical trials must clinical trial results information be submitted? (see Sec. IV.C.2 of the Final Rule for discussion)
  • For a discussion of "Submission of Results Information for Applicable Clinical Trials of Unapproved, Unlicensed, or Uncleared Products for Any Use," see Sec. III.B.
  • 42 CFR 11.48 What constitutes clinical trial results information?

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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 1 year after the primary completion date.

See the statutory provision for completion date (PDF) and the following FAQ for more information:

Regulations (42 CFR Part 11)

In general, the final rule requires the submission of results information not later than 1 year after the completion date (referred to as the "primary completion date") of the clinical trial, which is defined as the date of final data collection for the primary outcome measure (81 FR 64983). For more information, see the following FAQs:

For information on regulatory requirements, see 42 CFR Part 11. In particular, see:

  • 42 CFR 11.44 When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42? (see Sec. IV.C.3 of the Final Rule for discussion)
    • § 11.44(a) Standard submission deadline (see Sec. IV.C.3 - §11.44(a))
    • § 11.44(d) Submitting partial results information (see Sec. IV.C.3 - §11.44(d))

Delayed Submission of Results Information

CERTIFICATION

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 prior to the date of (i.e., the day before) the standard submission deadline for results information (or no later than 1 year after the ACT's primary completion date):

  • 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").
    • Results deadline:
      (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.

  • 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").
    • Results deadline:
      (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.

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).

PARTIAL RESULTS

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).

Regulations (42 CFR Part 11)

Under the final rule, results information submission could be delayed for up to 2 additional years from the date of submission of a certification that either (1) an unapproved, unlicensed, or uncleared product studied in the trial is still under development by the manufacturer or (2) that approval will be sought within 1 year after the primary completion date of the trial for a new use of an approved, licensed, or cleared product that is being studied in the trial (81 FR 64983).

For information on regulatory requirements, see 42 CFR Part 11. In particular, see:

  • 42 CFR 11.44 When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42? (see Sec. IV.C.3 of the Final Rule for discussion)
    • § 11.44(b) Delayed submission of results information with certification if seeking approval, licensure, or clearance of a new use (see Sec. IV.C.3 - §11.44(b) and (c))
    • § 11.44(c) Delayed submission of results with certification if seeking initial approval, licensure, or clearance (see Sec. IV.C.3 - § 11.44(b) & (c))
    • § 11.44(d) Submitting partial results information (see Sec. IV.C.4 - § 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.

Regulations (42 CFR Part 11)

The final rule permits responsible parties to request extensions to the results information submission deadlines for "good cause" (81 FR 64983).]

For information on regulatory requirements, see 42 CFR Part 11. In particular, see:

  • 42 CFR 11.44 When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42? (see Sec. IV.C.3 for discussion)
  • § 11.44(e) Extensions for good cause (see Sec. IV.C.3 - §11.44(e))

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.

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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:

Regulations (42 CFR Part 11)

The final rule outlines the potential civil or criminal actions, including civil monetary penalty actions, and grant funding actions that may be taken if responsible parties fail to comply with the rule's requirements. It does not outline all potential legal consequences, e.g., laws governing the veracity of information submitted to the federal government, however, and should not be understood as describing the only types of enforcement that the government might undertake with respect to compliance with the provisions of section 402(j) of the PHS Act, including its implementing regulations. [81 FR 64983]

For more information on the potential legal consequences of non-compliance, see:

  • 42 CFR 11.66 What are potential legal consequences of not complying with the requirements of this part?
  • Sec. IV.E.1 of the Final Rule for a discussion

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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.

FDA

Certification Requirements

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:

See the statutory provision requiring FDA to amend the informed consent regulations (PDF) for more information.

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Learn More

This page last reviewed in January 2021

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'display of written, printed, or graphic matter upon the immediate container of any article...'

The term 'immediate container' does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear 'on the outside container or wrapper, if any there be, or the retail package of such article, or is easily legible through the outside container of wrapper.'

Section 201(m) defines 'labeling' as:

'all labels and other written, printed, or graphic matter

(1) upon any article or any of its containers or wrappers, or

(2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.

The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. 'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.

Sours: https://www.fda.gov/medical-devices/overview-device-regulation/device-labeling

Does My Device Labeling Comply with 21 CFR 801_

Medical device labeling is a core requirement for getting your device onto the market.

21 CFR 801 covers general device labeling and the use of symbols. One thing the regulation makes clear is that the term “labeling” isn’t just about a sticker or engraving on a device.

Labeling covers all types of labels that are associated with your medical device - the instructions, the box it comes in, and of course, any label on the device itself. When you are checking to see what is required for your device, you’ll need to look at the general requirements and any sub-categories that may apply to your particular type of device.

Here’s what you need to know about being compliant with 21 CFR 801:

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21 CFR 801 - How the FDA regulates device labeling in the US

In the United States, medical device labeling is regulated by FDA under these three laws:

  1. The Food, Drug and Cosmetic (FD&C) Act

  2. The Fair Packaging and Labeling Act

  3. The Radiation Control of Health and Safety Act

These laws are implemented in the form of regulations, of which 21 CFR 801 regulates general device labeling. Key concerns are that the user (or layman) of the medical device must be able to understand labeling so that they can operate the device safely and for the purposes intended, and that labeling must not be misleading or false.

It’s worth noting how the term “label” is defined under Section 201(k) of the FFDCA, the law under which FDA may seek action against regulated products:

  • 'display of written, printed, or graphic matter upon the immediate container of any article...'

The term 'immediate container' does not include package liners. Any word, statement, or other information appearing on the immediate container must also appear 'on the outside container or wrapper if any there be, or the retail package of such article, or is easily legible through the outside container or wrapper.'

Section 201(m) defines a 'labeling' as:

  • 'all labels and other written, printed, or graphic matter
    (1) upon any article or any of its containers or wrappers, or
    (2) accompanying such article' at any time while a device is held for sale after shipment or delivery for shipment in interstate commerce.

The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instruction books, direction sheets, fillers, etc. 'Accompanying' also includes labeling that is brought together with the device after shipment or delivery for shipment in interstate commerce.

In other words, FDA wants to see that your labeling: is easy to follow, has all the information that is required and doesn’t have any information that is false or misleading.

 

What are the different subparts of 21 CFR 801?

Here are the subparts found under 21 CFR 801:

 

Subpart A: General labeling provisions

General labeling provisions include the meaning of “intended uses” for the purpose of labeling and guidelines on adequate “directions for use.” This section also discusses misleading statements and required statements for the Spanish language.

The general labeling provisions include date format requirements as well as the requirements for labeling specific to the name and place of business of the manufacturer, packer or distributor. Lastly, Subpart A includes a list of relevant definitions for terms used throughout 21 CFR 801.

 

Subpart B: Labeling Requirements for Unique Device Identification

All medical devices must bear a unique device identifier (UDI, unless it falls under the list of exceptions which are found at 21 CFR 801.30. If your device is not required to bear a unique identifier, you still may choose to do so voluntarily.

The rest of Subpart B contains the requirements for the UDI form, requirements for SaMD (Software as Medical Device) labeling and requests for exceptions.

 

Subpart C: Labeling Requirements for Over-the-Counter devices

This subpart provides guidelines for all over-the-counter devices, including how the principal display panel and statement of identity must be displayed. There is a list of requirements pertaining to how you must declare the net quantity of contents, which will depend on your device type.

 

Subpart D: Exemptions from Adequate Directions for Use

This section outlines conditions for exemptions from adequate directions for use. Examples of this type of exemption include, but are not limited to, in vitro diagnostic products, prescription devices, and devices for which adequate directions for use are commonly known.

 

Subpart E: Other exemptions

There are some situations where the FDA issues further exemptions to labeling, of which are outlined in Subpart E. For example, where a product is packaged and shipped in a location different from where it will be processed, repacked and labeled.

 

Subpart H: Special Requirements for Specific Devices

This section covers specific types of devices, such as dentures, eyeglasses, hearing aids, devices with Ozone and devices with CFCs. 

 

How to apply 21 CFR 801 when designing my device labeling

The concept of “designing device labeling” is an important one to consider early on, bearing the applicable 21 CFR 801 regulations in mind when doing so. What is it that you want your labeling to say? How do you want it advertised?

Depending on your regulatory plan, device labeling design will vary. For example, if you’re going down the 510(k) submission route, your medical device labeling will be limited to what’s found on your predicate device.

If you’re prepared to take the De Novo route, you may not have the same labeling limitations as you would with a 510(k), but you will assume a larger regulatory burden upfront in meeting requirements that would have otherwise been satisfied by a predicate device, such as testing.

Your device labeling should take into account whichever regulatory pathway you choose to pursue as well as any exemptions (such as wellness) that apply. Importantly, your labeling is part of your design outputs and should reflect what you have documented for those.

In compliance with 21 CFR 801, remember that any written, printed or graphic material on packaging or accompanying the device also falls under the “labeling” regulations. Address labeling early on in your planning so that you will be prepared when it is needed.

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Your labeling needs to comply with 21 CFR 801 and to achieve this, you need well-organized design controls to inform your labeling. Keep your documentation up-to-date and easily located with a purpose-built eQMS solution.

Greenlight Guru is the only eQMS built exclusively for medical devices. Our platform is built and kept up to date with the latest industry regulations and standards in mind to keep medical device companies compliant with 21 CFR 801 as well as other regulatory requirements.

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Sours: https://www.greenlight.guru/blog/21-cfr-801

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