The Ultimate Primer on FDA 21 CFR

  FDA

What is FDA 21 CFR - Code of Federal Regulations?

The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. Title 21 of the CFR is reserved for rules of the Food and Drug Administration. Each title (or volume) of the CFR is revised once each calendar year. A revised Title 21 is issued on approximately April 1st of each year.

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act).  Under section 520(f) of the act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for medical devices. This regulation became effective on December 18, 1978, and was codified under part 820. The CFR is divided into 50 titles that represent broad areas subject to federal regulation.

FDA 21 CFR Part 820 (QUALITY SYSTEM REGULATION)

FOOD AND DRUG ADMINISTRATION ⇒ DEPARTMENT OF HEALTH AND HUMAN SERVICES ⇒ MEDICAL DEVICES ⇒ QUALITY SYSTEM REGULATION

Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, that manufacturer need only comply with those requirements applicable to the operations in which it is engaged.

FDA 21 CFR Part 820.30 (QUALITY SYSTEM REGULATION – DESIGN CONTROLS)

FOOD AND DRUG ADMINISTRATION ⇒ DEPARTMENT OF HEALTH AND HUMAN SERVICES ⇒ MEDICAL DEVICES ⇒ QUALITY SYSTEM REGULATION ⇒ DESIGN CONTROLS

Each manufacturer of any class III or class II device, and the class I devices listed in paragraph of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.

The following class I devices are subject to design controls:

(i) Devices automated with computer software; and

(ii) The devices listed in the following chart.

Design and development planning: Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.

FDA 21 CFR Part 812 (INVESTIGATIONAL DEVICE EXEMPTIONS)

FOOD AND DRUG ADMINISTRATION ⇒ DEPARTMENT OF HEALTH AND HUMAN SERVICES ⇒ MEDICAL DEVICES ⇒ INVESTIGATIONAL DEVICE EXEMPTIONS

The purpose of this part is to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose. This part provides procedures for the conduct of clinical investigations of devices. An approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device. An IDE approved under 812.30 or considered approved under 812.2(b) exempts a device from the requirements of the following sections of the Federal Food, Drug, and Cosmetic Act (the act) and regulations issued thereunder: Misbranding under section 502 of the act, registration, listing, and premarket notification under section 510, performance standards under section 514, premarket approval under section 515, a banned device regulation under section 516, records and reports under section 519, restricted device requirements under section 520(e), good manufacturing practice requirements under section 520(f) except for the requirements found in 820.30, if applicable (unless the sponsor states an intention to comply with these requirements under 812.20(b)(3) or 812.140(b)(4)(v)) and color additive requirements under section 721.

FDA 21 CFR Part 803 (MEDICAL DEVICE REPORTING)

FOOD AND DRUG ADMINISTRATION ⇒ DEPARTMENT OF HEALTH AND HUMAN SERVICES ⇒ MEDICAL DEVICES ⇒ MEDICAL DEVICE REPORTING

This part establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified followup. These reports help us to protect the public health by helping to ensure that devices are not adulterated or misbranded and are safe and effective for their intended use. If you are a medical device distributor, you must maintain records (files) of incidents, but you are not required to report these incidents.

This part supplements and does not supersede other provisions of this chapter, including the provisions of part 820 of this chapter.

References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

49 CFR Part 40 (Procedures for Transportation Workplace Drug and Alcohol Testing Programs)

The Department of Transportation’s (DOT) rule, 49 CFR Part 40, describes required procedures for conducting workplace drug and alcohol testing for the Federally regulated transportation industry. 

Who does this regulation cover?

This part tells all parties who conduct drug and alcohol tests required by Department of Transportation (DOT) agency regulations how to conduct these tests and what procedures to use. This part concerns the activities of transportation employers, safety-sensitive transportation employees (including self-employed individuals, contractors and volunteers as covered by DOT agency regulations), and service agents. Nothing in this part is intended to supersede or conflict with the implementation of the Federal Railroad Administration’s post-accident testing program (see 49 CFR 219.200).

FDA 21 CFR Part 312 (INVESTIGATIONAL NEW DRUG APPLICATION)

FOOD AND DRUG ADMINISTRATION ⇒ DEPARTMENT OF HEALTH AND HUMAN SERVICES ⇒ INVESTIGATIONAL NEW DRUG APPLICATION

This part contains procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND’s). An investigational new drug for which an IND is in effect in accordance with this part is exempt from the premarketing approval requirements that are otherwise applicable and may be shipped lawfully for the purpose of conducting clinical investigations of this drug. References in this part to regulations in the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

FDA 29 CFR Part 1910.134 (Personal Protective Equipment – Respiratory Protection)

OCCUPATIONAL SAFETY AND HEALTH STANDARDS ⇒ PERSONAL PROTECTIVE EQUIPMENT ⇒ RESPIRATORY PROTECTION

In the control of those occupational diseases caused by breathing air contaminated with harmful dusts, fogs, fumes, mists, gases, smokes, sprays, or vapors, the primary objective shall be to prevent atmospheric contamination. This shall be accomplished as far as feasible by accepted engineering control measures (for example, enclosure or confinement of the operation, general and local ventilation, and substitution of less toxic materials). When effective engineering controls are not feasible, or while they are being instituted, appropriate respirators shall be used pursuant to this section.

FDA 29 CFR Part 1910.119 (Process Safety Management of Highly Hazardous Chemicals)

OCCUPATIONAL SAFETY AND HEALTH STANDARDS ⇒ HAZARDOUS MATERIALS ⇒ PROCESS SAFETY MANAGEMENT OF HIGHLY HAZARDOUS CHEMICALS

This section contains requirements for preventing or minimizing the consequences of catastrophic releases of toxic, reactive, flammable, or explosive chemicals. These releases may result in toxic, fire or explosion hazards. A process which involves a chemical at or above the specified threshold quantities listed in this section:

1910.119(a)(1)(ii)

A process which involves a Category 1 flammable gas (as defined in 1910.1200(c)) or a flammable liquid with a flashpoint below 100 °F (37.8 °C) on site in one location, in a quantity of 10,000 pounds (4535.9 kg) or more.

1910.119(a)(1)(ii)(A)

Hydrocarbon fuels used solely for workplace consumption as a fuel (e.g., propane used for comfort heating, gasoline for vehicle refueling), if such fuels are not a part of a process containing another highly hazardous chemical covered by this standard.

1910.119(a)(1)(ii)(B)

Flammable liquids with a flashpoint below 100 °F (37.8 °C) stored in atmospheric tanks or transferred which are kept below their normal boiling point without benefit of chilling or refrigeration.

1910.119(a)(2)(i)

Retail facilities.

1910.119(a)(2)(ii)

Oil or gas well drilling or servicing operations.

1910.119(a)(2)(iii)

Normally unoccupied remote facilities.

FDA 29 CFR Part 1910.146 (Permit Required confined spaces)

OCCUPATIONAL SAFETY AND HEALTH STANDARDS ⇒ HAZARDOUS MATERIAL GENERAL ENVIRONMENTAL CONTROLS ⇒ PERMIT-REQUIRED CONFINED SPACES

This section contains requirements for practices and procedures to protect employees in general industry from the hazards of entry into permit-required confined spaces. This section does not apply to agriculture, to construction, or to shipyard employment (Parts 1928, 1926, and 1915 of this chapter, respectively).

The conditions that must exist in a permit space to allow entry and to ensure that employees involved with a permit-required confined space entry can safely enter into and work within the space. An individual stationed outside one or more permit spaces who monitors the authorized entrants and who performs all attendant’s duties assigned in the employer’s permit space program. The absolute closure of a pipe, line, or duct by the fastening of a solid plate (such as a spectacle blind or a skillet blind) that completely covers the bore and that is capable of withstanding the maximum pressure of the pipe, line, or duct with no leakage beyond the plate.

Confined space is a space that:

(1) Is large enough and so configured that an employee can bodily enter and perform assigned work.

(2) Has limited or restricted means for entry or exit (for example, tanks, vessels, silos, storage bins, hoppers, vaults, and pits are spaces that may have limited means of entry.)

(3) Is not designed for continuous employee occupancy.

FDA 29 CFR Part 1910.147 (Inspection Procedures and Interpretive Guidance)

OSHA INSTRUCTION ⇒ THE CONTROL OF HAZARDOUS ENERGY (LOCKOUT/TAGOUT) ⇒ INSPECTION PROCEDURES AND INTERPRETIVE GUIDANCE

Purpose: This instruction establishes policies and provides clarification to ensure uniform enforcement of the Lockout/Tagout Standards.

Scope: This instruction applies OSHA-wide.

References:

1. General Industry Standards, 29 CFR 1910, Subpart O, Subpart S, and other specific subparts.

2. OSHA Instruction CPL 2.45B, June 15, 1989, the Revised Field Operations Manual (FOM).

D. Effective Date of Requirements. All requirements of 29 CFR 1910.147 have an effective date of January 2, 1990. The information collection requirements contained in this section have been approved by the Office of Management and Budget (OMB) and listed under OMB control number 1218-0150, as announced at Federal Register, Volume 54, No. 199, October 17, 1989.

Action: Regional Administrators and Area Directors shall ensure that the guidelines and interpretive guidance in this instruction are followed and that compliance officers are familiar with the contents of the standard.

FDA 21 CFR Part 117 (CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD)

FOOD AND DRUG ADMINISTRATION ⇒ DEPARTMENT OF HEALTH AND HUMAN SERVICES ⇒ FOOD FOR HUMAN CONSUMPTION ⇒ CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

The criteria and definitions in this part apply in determining whether a food is:

(1) Adulterated within the meaning of:

Section 402(a)(3) of the Federal Food, Drug, and Cosmetic Act in that the food has been manufactured under such conditions that it is unfit for food or Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act in that the food has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.

(2) In violation of section 361 of the Public Health Service Act (42 U.S.C. 264).

The operation of a facility that manufactures, processes, packs, or holds food for sale in the United States if the owner, operator, or agent in charge of such facility is required to comply with, and is not in compliance with, section 418 of the Federal Food, Drug, and Cosmetic Act or subpart C, D, E, F, or G of this part is a prohibited act under section 301(uu) of the Federal Food, Drug, and Cosmetic Act. Food covered by specific current good manufacturing practice regulations also is subject to the requirements of those regulations.

FDA 21 CFR Part 210 (CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS)

FOOD AND DRUG ADMINISTRATION ⇒ DEPARTMENT OF HEALTH AND HUMAN SERVICES ⇒ CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS

The regulations set forth in this part and in parts 211, 225, and 226 of this chapter contains the minimum current good manufacturing practice for methods to be used in, and the facilities or controls to be used for, the manufacture, processing, packing, or holding of a drug to assure that such drug meets the requirements of the act as to safety, and has the identity and strength and meets the quality and purity characteristics that it purports or is represented to possess.

The failure to comply with any regulation set forth in this part and in parts 211, 225, and 226 of this chapter in the manufacture, processing, packing, or holding of a drug shall render such drug to be adulterated under section 501(a)(2)(B) of the act and such drug, as well as the person who is responsible for the failure to comply, shall be subject to regulatory action.

Owners and operators of establishments engaged in the recovery, donor screening, testing (including donor testing), processing, storage, labeling, packaging, or distribution of human cells, tissues, and cellular and tissue-based products (HCT/Ps), as defined in 1271.3(d) of this chapter, that are drugs (subject to review under an application submitted under section 505 of the act or under a biological product license application under section 351 of the Public Health Service Act), are subject to the donor-eligibility and applicable current good tissue practice procedures set forth in part 1271 subparts C and D of this chapter, in addition to the regulations in this part and in parts 211, 225, and 226 of this chapter. Failure to comply with any applicable regulation set forth in this part, in parts 211, 225, and 226 of this chapter, in part 1271 subpart C of this chapter, or in part 1271 subpart D of this chapter with respect to the manufacture, processing, packing or holding of a drug, renders an HCT/P adulterated under section 501(a)(2)(B) of the act. Such HCT/P, as well as the person who is responsible for the failure to comply, is subject to regulatory action.

FDA 21 CFR Part 211 (CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS)

FOOD AND DRUG ADMINISTRATION ⇒ DEPARTMENT OF HEALTH AND HUMAN SERVICES ⇒ CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

The regulations in this part contain the minimum current good manufacturing practice for preparation of drug products (excluding positron emission tomography drugs) for administration to humans or animals. The current good manufacturing practice regulations in this chapter as they pertain to drug products; in parts 600 through 680 of this chapter, as they pertain to drugs that are also biological products for human use; and in part 1271 of this chapter, as they are applicable to drugs that are also human cells, tissues, and cellular and tissue-based products (HCT/Ps) and that are drugs (subject to review under an application submitted under section 505 of the act or under a biological product license application under section 351 of the Public Health Service Act); supplement and do not supersede the regulations in this part unless the regulations explicitly provide otherwise.

In the event of a conflict between applicable regulations in this part and in other parts of this chapter, or in parts 600 through 680 of this chapter, or in part 1271 of this chapter, the regulation specifically applicable to the drug product in question shall supersede the more general.

FDA 21 CFR Part 111 (Current Good Manufacturing Practice In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements) 

FOOD AND DRUG ADMINISTRATION ⇒ DEPARTMENT OF HEALTH AND HUMAN SERVICES ⇒ FOOD FOR HUMAN CONSUMPTION ⇒ CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

You are subject to this part if you manufacture, package, label, or hold dietary supplements, including:

(1) A dietary supplement you manufacture but that is packaged or labeled by another person; and

(2) A dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.

(b) The requirements pertaining to holding dietary supplements do not apply to you if you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sales to individual consumers. A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers.

FDA 21 CFR Part 110 (Current Good Manufacturing Practice In Manufacturing, Packing, Or Holding Human Food)

FOOD AND DRUG ADMINISTRATION ⇒ DEPARTMENT OF HEALTH AND HUMAN SERVICES ⇒ FOOD FOR HUMAN CONSUMPTION ⇒ CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) are applicable to such terms when used in this part. Acid foods or acidified foods that have an equilibrium pH of 4.6 or below. Adequate that which is needed to accomplish the intended purpose in keeping with good public health practice. Batter a semifluid substance, usually composed of flour and other ingredients, into which principal components of food are dipped or with which they are coated, or which may be used directly to form bakery foods.

Blanching, except for tree nuts and peanuts pre-packaging heat treatment of foodstuffs for a sufficient time and at a sufficient temperature to partially or completely inactivate the naturally occurring enzymes and to effect other physical or biochemical changes in the food. Critical control point in a food process where there is a high probability that improper control may cause, allow, or contribute to a hazard or to filth in the final food or decomposition of the final food.

FDA 21 CFR Part 806 (Reports Of Corrections And Removals)

FOOD AND DRUG ADMINISTRATION ⇒ DEPARTMENT OF HEALTH AND HUMAN SERVICES ⇒ MEDICAL DEVICES ⇒ REPORTS OF CORRECTIONS AND REMOVALS

This part implements the provisions of section 519(g) of the Federal Food, Drug, and Cosmetic Act (the act) requiring device manufacturers and importers to report promptly to the Food and Drug Administration (FDA) certain actions concerning device corrections and removals, and to maintain records of all corrections and removals regardless of whether such corrections and removals are required to be reported to FDA.

The following actions are exempt from the reporting requirements of this part:

(1) Actions taken by device manufacturers or importers to improve the performance or quality of a device but that do not reduce a risk to health posed by the device or remedy a violation of the act caused by the device.

(2) Market withdrawal as defined in 806.2

(3) Routine servicing as defined in 806.2

(4) Stock recovery as defined in 806.2

[62 FR 27191, May 19, 1997, as amended at 63 FR 42232, Aug. 7, 1998; 84 FR 12083, Apr. 1, 2019]

FDA 21 CFR Part 807 (Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices)

FOOD AND DRUG ADMINISTRATION ⇒ DEPARTMENT OF HEALTH AND HUMAN SERVICES ⇒ MEDICAL DEVICES ⇒ ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

Federal Food, Drug, and Cosmetic Act for any distribution of a device intended for human use which is held or offered for sale. A place of business under one management at one general physical location at which a device is manufactured, assembled, or otherwise processed. Manufacture, preparation, propagation, compounding, assembly, or processing of a device means the making by chemical, physical, biological, or other procedures of any article that meets the definition of device in section 201(h) of the act.

The person designated by the owner or operator of an establishment as responsible for the following:

  • The annual registration of the establishment;
  • Contact with the Food and Drug Administration for device listing;
  • Maintenance and submission of a current list of officers and directors to the Food and Drug Administration upon the request of the Commissioner; and
  • The receipt of pertinent correspondence from the Food and Drug Administration directed to and involving the owner or operator and/or any of the firm’s establishments.

FDA 21 CFR Part 11 Compliance Checklist

FOOD AND DRUG ADMINISTRATION ⇒ DEPARTMENT OF HEALTH AND HUMAN SERVICES ⇒ ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under the requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means.

The following checklist of terms apply to this part:

(1) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-903 (21 U.S.C. 321-393)).

(2) Agency means the Food and Drug Administration.

(3) Biometrics means a method of verifying an individual’s identity based on measurement of the individual’s physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable.

(4) Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

(5) Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified.

(6) Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.

(7) Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.

(8) Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.

(9) Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system.

FDA 21 CFR Part 1271 (HUMAN CELLS, TISSUES, CELLULAR AND TISSUE-BASED PRODUCTS)

FOOD AND DRUG ADMINISTRATION ⇒ DEPARTMENT OF HEALTH AND HUMAN SERVICES ⇒ REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION ⇒ HUMAN CELLS, TISSUES, CELLULAR AND TISSUE-BASED PRODUCTS

The purpose of this part, in conjunction with 207.9(a)(5), 210.1(c), 210.2, 807.20(d), and 820.1(a) of this chapter, is to create an electronic registration and listing system for establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/P’s) and to establish donor-eligibility, current good tissue practice, and other procedures to prevent the introduction, transmission, and spread of communicable diseases by HCT/P’s.

If you are an establishment that manufactures HCT/P’s that are regulated solely under the authority of section 361 of the Public Health Service Act (the PHS Act), this part requires you to register and list your HCT/P’s with the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research and to comply with the other requirements contained in this part, whether or not the HCT/P enters into interstate commerce. Those HCT/P’s that are regulated solely under the authority of section 361 of the PHS Act are described in 1271.10.

If you are an establishment that manufactures HCT/P’s that are regulated as drugs, devices and/or biological products under section 351 of the PHS Act and/or the Federal Food, Drug, and Cosmetic Act, 207.9(a)(5) and 807.20(d) of this chapter require you to register and list your HCT/P’s following the procedures in part 207 (if a drug and/or biological product) of this chapter or part 807 (if a device) of this chapter. Sections 210.1(c), 210.2, 211.1(b), and 820.1(a) of this chapter require you to comply with the donor-eligibility procedures in subpart C of this part and the current good tissue practice procedures in subpart D of this part, in addition to all other applicable regulations.

45 CFR Part 46

HHS regulations at 45 CFR part 46 stipulate substantive and procedural requirements for investigators and institutions engaged in HHS-supported or -conducted research. Specifically, providing definitions and information about the application of the regulations, specific sections of the regulations.

The HHS regulations, 45 CFR part 46, include four subparts: 

  1. Known as the Federal Policy or the “Common Rule”
  2. Additional protections for pregnant women, human fetuses, and neonates
  3. Additional protections for prisoners
  4. Additional protections for children.

The regulations found at 45 CFR part 46 are based in large part on the Belmont Report and were written to offer basic protections to human subjects involved in both biomedical and behavioral research conducted or supported by HHS. In 1991, 14 other Federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects, identical to subpart A of 45 CFR part 46 of the HHS regulations. This uniform set of regulations is the Federal Policy for the Protection of Human Subjects, informally known as the “Common Rule.” In 1995 the Central Intelligence Agency was required by Executive Order to comply with all subparts of the HHS regulations.

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The Ultimate Primer on FDA 21 CFR
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The Ultimate Primer on FDA 21 CFR
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The Code of Federal Regulations (CFR) is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. Title 21 of the CFR is reserved for rules of the Food and Drug Administration. Each title (or volume) of the CFR is revised once each calendar year. A revised Title 21 is issued on approximately April 1st of each year.
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