cfr_sections
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44 rows where part_number = 830 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 10:10:5.0.2.5.28.0.16.1 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | § 830.1 Scope. | DOE | This part governs the conduct of DOE contractors, DOE personnel, and other persons conducting activities (including providing items and services) that affect, or may affect, the safety of DOE nuclear facilities. | |||||||
| 10:10:5.0.2.5.28.0.16.2 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | § 830.2 Exclusions. | DOE | This part does not apply to: (a) Activities that are regulated through a license by the Nuclear Regulatory Commission (NRC) or a State under an Agreement with the NRC, including activities certified by the NRC under section 1701 of the Atomic Energy Act (Act); (b) Activities conducted under the authority of the Director, Naval Nuclear Propulsion, pursuant to Executive Order 12344, as set forth in Public Law 106- 65; (c) Transportation activities which are regulated by the Department of Transportation; (d) Activities conducted under the Nuclear Waste Policy Act of 1982, as amended, and any facility identified under section 202(5) of the Energy Reorganization Act of 1974, as amended; and (e) Activities related to the launch approval and actual launch of nuclear energy systems into space. | |||||||
| 10:10:5.0.2.5.28.0.16.3 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | § 830.3 Definitions. | DOE | (a) The following definitions apply to this part: Administrative controls means the provisions relating to organization and management, procedures, recordkeeping, assessment, and reporting necessary to ensure safe operation of a facility. Bases appendix means an appendix that describes the basis of the limits and other requirements in technical safety requirements. Critical assembly means special nuclear devices designed and used to sustain nuclear reactions, which may be subject to frequent core and lattice configuration change and which frequently may be used as mockups of reactor configurations. Criticality means the condition in which a nuclear fission chain reaction becomes self-sustaining. Design features means the design features of a nuclear facility specified in the technical safety requirements that, if altered or modified, would have a significant effect on safe operation. Document means recorded information that describes, specifies, reports, certifies, requires, or provides data or results. Documented safety analysis means a documented analysis of the extent to which a nuclear facility can be operated safely with respect to workers, the public, and the environment, including a description of the conditions, safe boundaries, and hazard controls that provide the basis for ensuring safety. Environmental restoration activities means the process(es) by which contaminated sites and facilities are identified and characterized and by which contamination is contained, treated, or removed and disposed. Fissionable materials means a nuclide capable of sustaining a neutron-induced chain reaction ( e.g., uranium-233, uranium-235, plutonium-238, plutonium-239, plutonium-241, neptunium-237, americium-241, and curium-244). Graded approach means the process of ensuring that the level of analysis, documentation, and actions used to comply with a requirement in this part are commensurate with: (1) The relative importance to safety, safeguards, and security; (2) The magnitude of any hazard involve… | |||||||
| 10:10:5.0.2.5.28.0.16.4 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | § 830.4 General requirements. | DOE | (a) No person may take or cause to be taken any action inconsistent with the requirements of this part. (b) A contractor responsible for a nuclear facility must ensure implementation of, and compliance with, the requirements of this part. (c) The requirements of this part must be implemented in a manner that provides reasonable assurance of adequate protection of workers, the public, and the environment from adverse consequences, taking into account the work to be performed and the associated hazards. (d) If there is no contractor for a DOE nuclear facility, DOE must ensure implementation of, and compliance with, the requirements of this part. | |||||||
| 10:10:5.0.2.5.28.0.16.5 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | § 830.5 Enforcement. | DOE | The requirements in this part are DOE Nuclear Safety Requirements and are subject to enforcement by all appropriate means, including the imposition of civil and criminal penalties in accordance with the provisions of 10 CFR part 820. | |||||||
| 10:10:5.0.2.5.28.0.16.6 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | § 830.6 Recordkeeping. | DOE | A contractor must maintain complete and accurate records as necessary to substantiate compliance with the requirements of this part. | |||||||
| 10:10:5.0.2.5.28.0.16.7 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | § 830.7 Graded approach. | DOE | Where appropriate, a contractor must use a graded approach to implement the requirements of this part, document the basis of the graded approach used, and submit that documentation to DOE. The graded approach may not be used in implementing the unreviewed safety question (USQ) process or in implementing technical safety requirements. | |||||||
| 10:10:5.0.2.5.28.1.16.1 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | A | Subpart A—Quality Assurance Requirements | § 830.120 Scope. | DOE | This subpart establishes quality assurance requirements for contractors conducting activities, including providing items or services that affect, or may affect, nuclear safety of DOE nuclear facilities. | |||||
| 10:10:5.0.2.5.28.1.16.2 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | A | Subpart A—Quality Assurance Requirements | § 830.121 Quality Assurance Program (QAP). | DOE | (a) Contractors conducting activities, including providing items or services, that affect, or may affect, the nuclear safety of DOE nuclear facilities must conduct work in accordance with the Quality Assurance criteria in § 830.122. (b) The contractor responsible for a DOE nuclear facility must: (1) Submit a QAP to DOE for approval and regard the QAP as approved 90 days after submittal, unless it is approved or rejected by DOE at an earlier date. (2) Modify the QAP as directed by DOE. (3) Annually submit any changes to the DOE-approved QAP to DOE for approval. Justify in the submittal why the changes continue to satisfy the quality assurance requirements. (4) Conduct work in accordance with the QAP. (c) The QAP must: (1) Describe how the quality assurance criteria of § 830.122 are satisfied. (2) Integrate the quality assurance criteria with the Safety Management System, or describe how the quality assurance criteria apply to the Safety Management System. (3) Use voluntary consensus standards in its development and implementation, where practicable and consistent with contractual and regulatory requirements, and identify the standards used. (4) Describe how the contractor responsible for the nuclear facility ensures that subcontractors and suppliers satisfy the criteria of § 830.122. | |||||
| 10:10:5.0.2.5.28.1.16.3 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | A | Subpart A—Quality Assurance Requirements | § 830.122 Quality assurance criteria. | DOE | The QAP must address the following management, performance, and assessment criteria: (a) Criterion 1—Management/Program. (1) Establish an organizational structure, functional responsibilities, levels of authority, and interfaces for those managing, performing, and assessing the work. (2) Establish management processes, including planning, scheduling, and providing resources for the work. (b) Criterion 2—Management/Personnel Training and Qualification. (1) Train and qualify personnel to be capable of performing their assigned work. (2) Provide continuing training to personnel to maintain their job proficiency. (c) Criterion 3—Management/Quality Improvement. (1) Establish and implement processes to detect and prevent quality problems. (2) Identify, control, and correct items, services, and processes that do not meet established requirements. (3) Identify the causes of problems and work to prevent recurrence as a part of correcting the problem. (4) Review item characteristics, process implementation, and other quality-related information to identify items, services, and processes needing improvement. (d) Criterion 4—Management/Documents and Records. (1) Prepare, review, approve, issue, use, and revise documents to prescribe processes, specify requirements, or establish design. (2) Specify, prepare, review, approve, and maintain records. (e) Criterion 5—Performance/Work Processes. (1) Perform work consistent with technical standards, administrative controls, and other hazard controls adopted to meet regulatory or contract requirements, using approved instructions, procedures, or other appropriate means. (2) Identify and control items to ensure their proper use. (3) Maintain items to prevent their damage, loss, or deterioration. (4) Calibrate and maintain equipment used for process monitoring or data collection. (f) Criterion 6—Performance/Design. (1) Design items and processes using sound engineering/scientific principles and appropriate standards. (2) Incorporate applicable requirements a… | |||||
| 10:10:5.0.2.5.28.2.16.1 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | B | Subpart B—Safety Basis Requirements | § 830.200 Scope. | DOE | This Subpart establishes safety basis requirements for Hazard Category 1, 2, and 3 DOE nuclear facilities. | |||||
| 10:10:5.0.2.5.28.2.16.2 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | B | Subpart B—Safety Basis Requirements | § 830.201 Performance of work. | DOE | A contractor must perform work in accordance with the DOE-approved safety basis for a Hazard Category 1, 2, or 3 DOE nuclear facility and, in particular, with the hazard controls that ensure adequate protection of workers, the public, and the environment. | |||||
| 10:10:5.0.2.5.28.2.16.3 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | B | Subpart B—Safety Basis Requirements | § 830.202 Safety basis. | DOE | (a) The contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must establish and maintain the safety basis for the facility. (b) In establishing the safety basis for a Hazard Category 1, 2, or 3 DOE nuclear facility, the contractor responsible for the facility must: (1) Define the scope of the work to be performed; (2) Identify and analyze the hazards associated with the work; (3) Categorize the facility consistent with DOE-STD-1027-92 (“Hazard Categorization and Accident Analysis Techniques for compliance with DOE Order 5480.23, Nuclear Safety Analysis Reports,” Change Notice 1, September 1997); (4) Prepare a documented safety analysis for the facility; and (5) Establish the hazard controls upon which the contractor will rely to ensure adequate protection of workers, the public, and the environment. (c) In maintaining the safety basis for a Hazard Category 1, 2, or 3 DOE nuclear facility, the contractor responsible for the facility must: (1) Update the safety basis to keep it current and to reflect changes in the facility, the work and the hazards as they are analyzed in the documented safety analysis; (2) Annually provide DOE the current documented safety analysis or a letter stating that there have been no changes in the documented safety analysis since the prior submittal; and (3) Incorporate in the safety basis any changes, conditions, or hazard controls directed by DOE. | |||||
| 10:10:5.0.2.5.28.2.16.4 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | B | Subpart B—Safety Basis Requirements | § 830.203 Unreviewed safety question process. | DOE | (a) The contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must establish, implement, and take actions consistent with a DOE-approved USQ procedure that meets the requirements of this section. (b) The contractor responsible for a new Hazard Category 1, 2, or 3 DOE nuclear facility must submit for DOE approval a procedure for its USQ process on a schedule that allows DOE approval in a safety evaluation report issued pursuant to § 830. 207(a) of this part. (c) The contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must implement the DOE-approved USQ procedure in situations where there is a: (1) Temporary or permanent change in the facility as described in the existing documented safety analysis; (2) Temporary or permanent change in the procedures as described in the existing documented safety analysis; (3) Test or experiment not described in the existing documented safety analysis; or (4) Potential inadequacy of the documented safety analysis because the analysis potentially may not be bounding or may be otherwise inadequate. (d) A contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must obtain DOE approval prior to taking any action determined to involve a USQ. (e) The contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must annually provide to DOE a summary of the USQ determinations performed since the prior submittal. (f) If a contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility discovers or is made aware of a potential inadequacy of the documented safety analysis, it must: (1) Take action, as appropriate, to place or maintain the facility in a safe condition until an evaluation of the safety of the situation is completed; (2) Notify DOE of the situation; (3) Perform a USQ determination and notify DOE promptly of the results; and (4) Submit the evaluation of the safety of the situation to DOE prior to removing any operational restrictions initiated to meet paragraph (f)(1) of… | |||||
| 10:10:5.0.2.5.28.2.16.5 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | B | Subpart B—Safety Basis Requirements | § 830.204 Documented safety analysis. | DOE | (a) The contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must obtain approval from DOE for the methodology used to prepare the documented safety analysis for the facility unless the contractor uses a methodology set forth in Table 1 of Appendix A to this part. (b) The documented safety analysis for a Hazard Category 1, 2, or 3 DOE nuclear facility must, as appropriate for the complexities and hazards associated with the facility: (1) Describe the facility (including the design of safety structures, systems and components) and the work to be performed; (2) Provide a systematic identification of both natural and man-made hazards associated with the facility; (3) Evaluate normal, abnormal, and accident conditions, including consideration of natural and man-made external events, identification of energy sources or processes that might contribute to the generation or uncontrolled release of radioactive and other hazardous materials, and consideration of the need for analysis of accidents which may be beyond the design basis of the facility; (4) Derive the hazard controls necessary to ensure adequate protection of workers, the public, and the environment, demonstrate the adequacy of these controls to eliminate, limit, or mitigate identified hazards, and define the process for maintaining the hazard controls current at all times and controlling their use; (5) Define the characteristics of the safety management programs necessary to ensure the safe operation of the facility, including (where applicable) quality assurance, procedures, maintenance, personnel training, conduct of operations, emergency preparedness, fire protection, waste management, and radiation protection; and (6) With respect to a nonreactor nuclear facility with fissionable material in a form and amount sufficient to pose a potential for criticality, define a criticality safety program that: (i) Ensures that operations with fissionable material remain subcritical under all normal and credible abnormal conditions; (ii… | |||||
| 10:10:5.0.2.5.28.2.16.6 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | B | Subpart B—Safety Basis Requirements | § 830.205 Technical safety requirements. | DOE | (a) A contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must: (1) Develop technical safety requirements that are derived from the documented safety analysis; (2) Prior to use, obtain DOE approval of technical safety requirements and any change to technical safety requirements; and (3) Notify DOE of any violation of a technical safety requirement. (b) A contractor may take emergency actions that depart from an approved technical safety requirement when no actions consistent with the technical safety requirement are immediately apparent, and when these actions are needed to protect workers, the public or the environment from imminent and significant harm. Such actions must be approved by a certified operator for a reactor or by a person in authority as designated in the technical safety requirements for nonreactor nuclear facilities. The contractor must report the emergency actions to DOE as soon as practicable. (c) A contractor for an environmental restoration activity may follow the provisions of 29 CFR 1910.120 or 29 CFR 1926.65 to develop the appropriate hazard controls (rather than the provisions for technical safety requirements in paragraph (a) of this section), provided the activity involves either: (1) Work not done within a permanent structure, or (2) The decommissioning of a facility with only low-level residual fixed radioactivity. | |||||
| 10:10:5.0.2.5.28.2.16.7 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | B | Subpart B—Safety Basis Requirements | § 830.206 Preliminary documented safety analysis. | DOE | Prior to construction of a new Hazard Category 1, 2, or 3 DOE nuclear facility or a major modification to an existing Hazard Category 1, 2, or 3 DOE nuclear facility, the contractor responsible for the design and construction of the new facility or major modification must: (a) Prepare a preliminary documented safety analysis for the facility, and (b) Obtain DOE approval of: (1) The nuclear safety design criteria to be used in preparing the preliminary documented safety analysis unless the contractor uses the design criteria in DOE Order 420.1, Facility Safety, or successor document; and (2) The preliminary documented safety analysis before the contractor can procure materials or components or begin construction; provided that DOE may authorize the contractor to perform limited procurement and construction activities without approval of a preliminary documented safety analysis if DOE determines that the activities are not detrimental to public health and safety and are in the best interests of DOE. | |||||
| 10:10:5.0.2.5.28.2.16.8 | 10 | Energy | III | 830 | PART 830—NUCLEAR SAFETY MANAGEMENT | B | Subpart B—Safety Basis Requirements | § 830.207 DOE approval of safety basis. | DOE | (a) With respect to a new Hazard Category 1, 2, or 3 DOE nuclear facility or a major modification to an existing Hazard Category 1, 2, or 3 DOE nuclear facility, a contractor may not begin operation of the facility or modification prior to the issuance of a safety evaluation report in which DOE approves the safety basis for the facility or modification. (b) Pending issuance of a safety evaluation report in which DOE approves an updated or amended safety basis for an existing Hazard Category 1, 2, or 3 DOE nuclear facility, the contractor responsible for the facility must continue to perform work in accordance with the DOE-approved safety basis for the facility and maintain the existing safety basis consistent with the requirements of this Subpart. | |||||
| 21:21:8.0.1.1.15.1.1.1 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | A | Subpart A—General Provisions | § 830.3 Definitions. | FDA | As used in this part: Automatic identification and data capture (AIDC) means any technology that conveys the unique device identifier or the device identifier of a device in a form that can be entered into an electronic patient record or other computer system via an automated process. Center Director means the Director of the Center for Devices and Radiological Health or the Director of the Center for Biologics Evaluation and Research, depending on which Center has been assigned lead responsibility for the device. Device package means a package that contains a fixed quantity of a particular version or model of a device. Expiration date means the date by which the label of a device states the device must or should be used. FDA, we, or us means the Food and Drug Administration. Federal Food, Drug, and Cosmetic Act means 21 U.S.C. 321 et seq., as amended. Finished device means any device or accessory to any device that is suitable for use or capable of functioning. Global Unique Device Identification Database (GUDID) means the database that serves as a repository of information to facilitate the identification of medical devices through their distribution and use. Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device means an HCT/P as defined in § 1271.3(d) of this chapter that does not meet the criteria in § 1271.10(a) and that is also regulated as a device. Issuing agency means an organization accredited by FDA to operate a system for the issuance of unique device identifiers. Label has the meaning set forth in section 201(k) of the Federal Food, Drug, and Cosmetic Act. Labeler means: (1) Any person who causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label; and (2) Any person who causes the label of a device to be replaced or modified with the intent that the device will be commercially distributed without any subsequent replacement or mod… | ||||
| 21:21:8.0.1.1.15.2.1.1 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | B | Subpart B—Requirements for a Unique Device Identifier | § 830.10 Incorporation by reference. | FDA | [78 FR 58823, Sept. 24, 2013, as amended at 88 FR 45067, July 14, 2023] | (a) Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, the Food and Drug Administration must publish notice of change in the Federal Register and the material must be available to the public. All approved material is available for inspection at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 301-827-6860, and is available from the source listed in paragraph (b) of this section. Copies are also available for purchase from the American National Standards Institute (ANSI), mailing address: ANSI, Attn: Customer Service Department, 25 West 43rd St., 4th floor, New York, NY 10036, phone: 212-642-4980, and may be ordered online at http://webstore.ansi.org/. The material is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (b) International Organization for Standardization (ISO), mailing address: ISO, Attn: ISO Central Secretariat, 1, ch. de la Voie-Creuse, Case postale 56, CH-1211 Geneva 20, Switzerland, phone (dialing from the United States): 011-41-22-749-0111, and may be ordered online at http://www.standardsinfo.net. (1) ISO/IEC 646:1991(E), Information technology—ISO 7-bit coded character set for information interchange (third edition; December 15, 1991), into §§ 830.20(c) and 830.100(b); (2) ISO/IEC 15459-2:2006(E), Information technology—Unique identifiers—Part 2: Registration procedures (second edition; March 1, 2006), into §§ 830.20(b) and 830.100(b); (3) ISO/IEC 15459-4:2008(E), Information technology—Unique identifiers—Part 4: Individual items (second edition; July 15, 2008), into §§ 830.20(b) and 830.100(b); (4) ISO/IEC 15459-6… | |||
| 21:21:8.0.1.1.15.2.1.2 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | B | Subpart B—Requirements for a Unique Device Identifier | § 830.20 Requirements for a unique device identifier. | FDA | [78 FR 58825, Sept. 24, 2013] | A unique device identifier (UDI) must: (a) Be issued under a system operated by FDA or an FDA-accredited issuing agency; (b) Conform to each of the following international standards: (1) ISO/IEC 15459-2, which is incorporated by reference at § 830.10; (2) ISO/IEC 15459-4, which is incorporated by reference at § 830.10; and (3) ISO/IEC 15459-6, which is incorporated by reference at § 830.10. (c) Use only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at § 830.10. | |||
| 21:21:8.0.1.1.15.2.1.3 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | B | Subpart B—Requirements for a Unique Device Identifier | § 830.40 Use and discontinuation of a device identifier. | FDA | [78 FR 58825, Sept. 24, 2013] | (a) Only one device identifier from any particular system for the issuance of unique device identifiers (UDIs) may be used to identify a particular version or model of a device. A particular version or model may be identified by UDIs from two or more systems for the issuance of UDIs. (b) A device identifier shall be used to identify only one version or model. (c) In the event that a version or model of a device is discontinued, its device identifier may not be reassigned to another device. If a discontinued version or model is re-introduced and no changes have been made that would require the use of a new device identifier, the device identifier that was previously in use may be used to identify the device. (d) In the event that an issuing agency relinquishes or does not renew its accreditation, you may continue to use a previously issued UDI until such time as § 830.50 requires you to assign a new device identifier. | |||
| 21:21:8.0.1.1.15.2.1.4 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | B | Subpart B—Requirements for a Unique Device Identifier | § 830.50 Changes that require use of a new device identifier. | FDA | [78 FR 58825, Sept. 24, 2013] | (a) Whenever you make a change to a device that is required to bear a unique device identifier (UDI) on its label, and the change results in a new version or model, you must assign a new device identifier to the new version or model. (b) Whenever you create a new device package, you must assign a new device identifier to the new device package. | |||
| 21:21:8.0.1.1.15.2.1.5 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | B | Subpart B—Requirements for a Unique Device Identifier | § 830.60 Relabeling of a device that is required to bear a unique device identifier. | FDA | [78 FR 58825, Sept. 24, 2013] | If you relabel a device that is required to bear a unique device identifier (UDI), you must: (a) Assign a new device identifier to the device, and (b) Keep a record showing the relationship of the prior device identifier to your new device identifier. | |||
| 21:21:8.0.1.1.15.3.1.1 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | C | Subpart C—FDA Accreditation of an Issuing Agency | § 830.100 FDA accreditation of an issuing agency. | FDA | (a) Eligibility. A private organization may apply for accreditation as an issuing agency. (b) Accreditation criteria. FDA may accredit an organization as an issuing agency, if the system it will operate: (1) Will employ unique device identifiers (UDIs) that meet the requirements of this part to adequately identify a device through its distribution and use; (2) Conforms to each of the following international standards: (i) ISO/IEC 15459-2, which is incorporated by reference at § 830.10; (ii) ISO/IEC 15459-4, which is incorporated by reference at § 830.10; (iii) ISO/IEC 15459-6, which is incorporated by reference at § 830.10. (3) Uses only characters and numbers from the invariant character set of ISO/IEC 646, which is incorporated by reference at § 830.10. (4) Will be available to all users according to a single set of consistent, fair, and reasonable terms and conditions. (5) Will protect against conflicts of interest between the issuing agency (and its officers, employees, and other agents) and labelers (and their officers, employees, and other agents) seeking to use UDIs that may impede the applicant's ability to independently operate a fair and neutral identifier system. | ||||
| 21:21:8.0.1.1.15.3.1.2 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | C | Subpart C—FDA Accreditation of an Issuing Agency | § 830.110 Application for accreditation as an issuing agency. | FDA | [78 FR 58825, Sept. 24, 2013, as amended at 81 FR 11429, Mar. 4, 2016; 85 FR 18443, Apr. 2, 2020] | (a) Application for initial accreditation. (1) An applicant seeking initial FDA accreditation as an issuing agency shall notify FDA of its desire to be accredited by sending a notification by email to: GUDIDSupport@fda.hhs.gov, or by correspondence to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002. (2) FDA will provide the applicant with additional information to aid in submission of an application for approval as an issuing agency, together with an email address for submission of an application. (3) The applicant shall furnish to FDA, via email to the email address provided in paragraph (a)(1) of this section, an application containing the following information, materials, and supporting documentation: (i) Name, address, and phone number of the applicant; (ii) Detailed descriptions of any standards or criteria the applicant will apply to participating labelers; (iii) A detailed description of the guidelines that govern assignment of a unique device identifier (UDI) to a device; (iv) A detailed description of the review and decisionmaking process the applicant will apply when determining whether a particular labeler may use the applicant's UDI system, including: (A) Copies of the application forms, guidelines, instructions, and other materials the applicant will send to medical device labelers who wish to use the applicant's unique device identification system; (B) Policies and procedures for notifying a labeler of deficiencies in its use of UDIs; (C) Procedures for monitoring a labeler's correction of deficiencies in its use of UDIs; (D) Policies and procedures for suspending or revoking a labeler's use of the applicant's UDI system, including any appeals process. (v) Description of the applicant's electronic data management system with respect to its review and decision processes and the applicant's ability to provide electronic data in a format compatible with FDA… | |||
| 21:21:8.0.1.1.15.3.1.3 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | C | Subpart C—FDA Accreditation of an Issuing Agency | § 830.120 Responsibilities of an FDA-accredited issuing agency. | FDA | To maintain its accreditation, an issuing agency must: (a) Operate a system for assignment of unique device identifiers (UDIs) that meets the requirements of § 830.20; (b) Make available information concerning its system for the assignment of UDIs; (c) Maintain a list of labelers that use its system for the assignment of UDIs and provide FDA a copy of such list in electronic form by December 31 of each year; (d) Upon request, provide FDA with information concerning a labeler that is employing the issuing agency's system for assignment of UDIs; and (e) Remain in compliance with the eligibility and accreditation criteria set forth in § 830.100. | ||||
| 21:21:8.0.1.1.15.3.1.4 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | C | Subpart C—FDA Accreditation of an Issuing Agency | § 830.130 Suspension or revocation of the accreditation of an issuing agency. | FDA | FDA may suspend or revoke the accreditation of an issuing agency if FDA finds, after providing the issuing agency with notice and opportunity for an informal hearing in accordance with part 16 of this chapter, that the issuing agency or any officer, employee, or other agent of the issuing agency: (a) Has been guilty of misrepresentation or failure to disclose required information in obtaining accreditation; (b) Has failed to fulfill the responsibilities outlined in § 830.120; (c) Has failed to protect against conflicts of interest that may impede the issuing agency's ability to independently operate a fair and neutral identifier system; (d) In the operation of the issuing agency, has engaged in any anticompetitive activity to restrain trade; or (e) Has violated or aided and abetted in the violation of any regulation issued under section 510(e) or section 519(f) of the Federal Food, Drug, and Cosmetic Act. | ||||
| 21:21:8.0.1.1.15.4.1.1 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | D | Subpart D—FDA as an Issuing Agency | § 830.200 When FDA will act as an issuing agency. | FDA | (a) During any period where there is no accredited issuing agency, FDA will act as an issuing agency. (b) If FDA determines that a significant number of small businesses would be substantially and adversely affected by the fees required by all accredited issuing agencies, FDA will act as an issuing agency. (c) FDA may, in its discretion, act as an issuing agency if we determine it is necessary for us to do so to ensure the continuity or the effectiveness of the system for the identification of medical devices. (d) FDA may, in its discretion, act as an issuing agency if we determine it is appropriate for us to do so in order to facilitate or implement an alternative granted under § 801.55 of this chapter. | ||||
| 21:21:8.0.1.1.15.4.1.2 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | D | Subpart D—FDA as an Issuing Agency | § 830.210 Eligibility for use of FDA as an issuing agency. | FDA | When FDA acts as an issuing agency, any labeler will be permitted to use FDA's unique device identification system, regardless of whether the labeler is considered a small business. | ||||
| 21:21:8.0.1.1.15.4.1.3 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | D | Subpart D—FDA as an Issuing Agency | § 830.220 Termination of FDA service as an issuing agency. | FDA | (a) FDA may end our services as an issuing agency if we determine that the conditions that prompted us to act no longer exist and that ending our services would not be likely to lead to a return of the conditions that prompted us to act. (b) If FDA has ended our services as an issuing agency, a labeler may continue to use a device identifier assigned under FDA's unique device identification system until such time as § 830.50 requires the use of a new device identifier. | ||||
| 21:21:8.0.1.1.15.5.1.1 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | E | Subpart E—Global Unique Device Identification Database | § 830.300 Devices subject to device identification data submission requirements. | FDA | (a) In general. The labeler of a device must provide the information required by this subpart for each version or model required to bear a unique device identifier (UDI). (b) Voluntary submission of information. If a labeler voluntarily includes a UDI on the label of a device under § 801.40, the labeler may also voluntarily submit information concerning that device under this part. (c) Exclusions. FDA may reject or remove any device identification data where: (1) The device identifier submitted does not conform to § 830.20; (2) The information concerns a device that is neither manufactured in the United States nor in interstate commerce in the United States, (3) The information concerns a product that FDA determines is not a device or a combination product that includes a device constituent part, (4) The information concerns a device or a combination product that requires, but does not have, FDA premarket approval, licensure, or clearance; (5) A device that FDA has banned under section 516 of the Federal Food, Drug, and Cosmetic Act; or (6) FDA has suspended the accreditation of the issuing agency that operates the system used by the labeler. | ||||
| 21:21:8.0.1.1.15.5.1.2 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | E | Subpart E—Global Unique Device Identification Database | § 830.310 Information required for unique device identification. | FDA | The contact for device identification designated under § 830.320(a) shall provide FDA with the following information concerning each version or model of a device required to bear a unique device identifier (UDI) on its label: (a) Concerning the labeler: (1) The name of the labeler; (2) A telephone number or email address that will allow FDA to communicate with the contact for device identification designated under § 830.320(a); and (3) The name of each issuing agency whose system is used by the labeler to assign UDIs used by the labeler. (b) Concerning each version or model of a device with a UDI on its label: (1) The device identifier portion of the UDI assigned to the version or model; (2) When reporting a substitution of a new device identifier that will be used in lieu of a previously reported identifier, the device identifier that was previously assigned to the version or model; (3) If § 801.45 of this chapter requires the device to bear a UDI as a permanent marking on the device itself, either: (i) A statement that the device identifier that appears as a permanent marking on the device is identical to that reported under paragraph (b)(1) of this section, or (ii) The device identifier portion of the UDI that appears as a permanent marking on the device; (4) The proprietary, trade, or brand name of the device as it appears on the label of the device; (5) Any version or model number or similar reference that appears on the label of the device; (6) If the device is labeled as sterile, a statement to that effect; (7) If the device is labeled as containing natural rubber latex that contacts humans, or is labeled as having packaging containing natural rubber latex that contacts humans, as described by §§ 801.437(b)(1), 801.437(b)(3), and 801.437(f) of this chapter, a statement to that effect; (8) Whether a patient may be safely exposed to magnetic resonance imaging, nuclear magnetic resonance imaging, or magnetic resonance tomography while using the device, or while the device is implanted in pati… | ||||
| 21:21:8.0.1.1.15.5.1.3 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | E | Subpart E—Global Unique Device Identification Database | § 830.320 Submission of unique device identification information. | FDA | [78 FR 58826, Sept. 24, 2013, as amended at 85 FR 18443, Apr. 2, 2020] | (a) Designation of contact for device identification. Each labeler must designate an individual to serve as the point of contact with FDA on matters relating to the identification of medical devices marketed by the labeler. The contact for device information is responsible for ensuring FDA is provided with all information required by this part. The contact for device information may authorize an issuing agency or any other person to provide information to FDA on behalf of the labeler. (b) Information shall be submitted via electronic means. All information required by this subpart shall be submitted electronically to FDA's Global Unique Device Identification Database (GUDID) in a format that we can process, review, and archive, unless the labeler has obtained a waiver from electronic submission of unique device identifier (UDI) data. (c) Waiver from electronic submission. (1) A labeler may request a waiver from electronic submission of UDI data by submitting a letter addressed to the appropriate Center Director explaining why electronic submission is not technologically feasible; send the request by email to: udi@fda.hhs.gov, or by correspondence to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3293, Silver Spring, MD 20993-0002. (2) If the establishment where the labeler is located has obtained a waiver from electronic submission of registration and listing information under section 510(p) of the Federal Food, Drug, and Cosmetic Act, the labeler is deemed to have a waiver from electronic submission of UDI data. (3) A labeler that has a waiver from electronic submission of UDI data must send a letter containing all of the information required by § 830.310, as well as any ancillary information permitted to be submitted under § 830.340 that the labeler wishes to submit, within the time permitted by § 830.330, addressed to: UDI Regulatory Policy Support, Center for Devices and Radiological Health, Food and… | |||
| 21:21:8.0.1.1.15.5.1.4 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | E | Subpart E—Global Unique Device Identification Database | § 830.330 Times for submission of unique device identification information. | FDA | (a) The labeler shall submit to FDA the information required by § 830.310 no later than the date the label of the device must bear a unique device identifier under § 801.20 of this chapter. (b) The labeler of a device shall submit to FDA an update to the information required by § 830.310 whenever the information changes. The updated information must be submitted no later than the date a device is first labeled with the changed information. If the information does not appear on the label of a device, the updated information must be submitted within 10 business days of the change. | ||||
| 21:21:8.0.1.1.15.5.1.5 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | E | Subpart E—Global Unique Device Identification Database | § 830.340 Voluntary submission of ancillary device identification information. | FDA | (a) You may not submit any information to the Global Unique Device Identification Database (GUDID) other than that specified by § 830.310, except where FDA acts to permit the submission of specified additional types of information, termed ancillary information. (b) FDA will provide information through the FDA Web site at http://www.fda.gov/udi/ concerning the types of ancillary information that may be submitted to the GUDID. (c) FDA may periodically change the types of ancillary information that may be submitted to the GUDID. We will announce any change on the FDA Web site at http://www.fda.gov/udi/ at least 60 days before making the change. | ||||
| 21:21:8.0.1.1.15.5.1.6 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | E | Subpart E—Global Unique Device Identification Database | § 830.350 Correction of information submitted to the Global Unique Device Identification Database. | FDA | (a) If FDA becomes aware that any information submitted to the Global Unique Device Identification Database (GUDID) appears to be incorrect or potentially misleading, we may notify the labeler of the specific information that appears to be incorrect, and request that the labeler provide corrected information or explain why the information is correct. The labeler must provide corrected information or provide a satisfactory explanation of why the information is correct within 30 days of receipt of FDA's notification. (b) If the labeler does not respond to FDA's notification within 30 days of receipt, or if FDA determines, at any time, that any information in the GUDID is incorrect or could be misleading, we may delete or correct the information. Any action taken by FDA under this paragraph does not relieve the labeler of its responsibility under paragraph (a) of this section to provide corrected information or an explanation of why the information previously submitted is correct. | ||||
| 21:21:8.0.1.1.15.5.1.7 | 21 | Food and Drugs | I | H | 830 | PART 830—UNIQUE DEVICE IDENTIFICATION | E | Subpart E—Global Unique Device Identification Database | § 830.360 Records to be maintained by the labeler. | FDA | (a) Each labeler shall retain, and submit to FDA upon specific request, records showing all unique device identifiers (UDIs) used to identify devices that must bear a UDI on their label, and the particular version or model associated with each device identifier. These records must be retained for 3 years from the date the labeler ceases to market the version or model. (b) Compliance with this section does not relieve the labeler of the need to comply with recordkeeping requirements of any other FDA regulation. | ||||
| 49:49:7.1.4.1.12.1.1.1 | 49 | Transportation | VIII | 830 | PART 830—NOTIFICATION AND REPORTING OF AIRCRAFT ACCIDENTS OR INCIDENTS AND OVERDUE AIRCRAFT, AND PRESERVATION OF AIRCRAFT WRECKAGE, MAIL, CARGO, AND RECORDS | A | Subpart A—General | § 830.1 Applicability. | NTSB | [60 FR 40112, Aug. 7, 1995] | This part contains rules pertaining to: (a) Initial notification and later reporting of aircraft incidents and accidents and certain other occurrences in the operation of aircraft, wherever they occur, when they involve civil aircraft of the United States; when they involve certain public aircraft, as specified in this part, wherever they occur; and when they involve foreign civil aircraft where the events occur in the United States, its territories, or its possessions. (b) Preservation of aircraft wreckage, mail, cargo, and records involving all civil and certain public aircraft accidents, as specified in this part, in the United States and its territories or possessions. | ||||
| 49:49:7.1.4.1.12.1.1.2 | 49 | Transportation | VIII | 830 | PART 830—NOTIFICATION AND REPORTING OF AIRCRAFT ACCIDENTS OR INCIDENTS AND OVERDUE AIRCRAFT, AND PRESERVATION OF AIRCRAFT WRECKAGE, MAIL, CARGO, AND RECORDS | A | Subpart A—General | § 830.2 Definitions. | NTSB | [53 FR 36982, Sept. 23, 1988, as amended at 60 FR 40112, Aug. 7, 1995; 75 FR 51955, Aug. 24, 2010; 87 FR 42104, July 14, 2022] | As used in this part the following words or phrases are defined as follows: Aircraft accident means an occurrence associated with the operation of an aircraft which takes place between the time any person boards the aircraft with the intention of flight and all such persons have disembarked, and in which any person suffers death or serious injury, or in which the aircraft receives substantial damage. For purposes of this part, the definition of “aircraft accident” includes “unmanned aircraft accident,” as defined herein. Civil aircraft means any aircraft other than a public aircraft. Fatal injury means any injury which results in death within 30 days of the accident. Incident means an occurrence other than an accident, associated with the operation of an aircraft, which affects or could affect the safety of operations. Operator means any person who causes or authorizes the operation of an aircraft, such as the owner, lessee, or bailee of an aircraft. Public aircraft means an aircraft used only for the United States Government, or an aircraft owned and operated (except for commercial purposes) or exclusively leased for at least 90 continuous days by a government other than the United States Government, including a State, the District of Columbia, a territory or possession of the United States, or a political subdivision of that government. “Public aircraft” does not include a government-owned aircraft transporting property for commercial purposes and does not include a government-owned aircraft transporting passengers other than: transporting (for other than commercial purposes) crewmembers or other persons aboard the aircraft whose presence is required to perform, or is associated with the performance of, a governmental function such as firefighting, search and rescue, law enforcement, aeronautical research, or biological or geological resource management; or transporting (for other than commercial purposes) persons aboard the aircraft if the aircraft is operated by the Armed Forces or an intelligence… | ||||
| 49:49:7.1.4.1.12.2.1.1 | 49 | Transportation | VIII | 830 | PART 830—NOTIFICATION AND REPORTING OF AIRCRAFT ACCIDENTS OR INCIDENTS AND OVERDUE AIRCRAFT, AND PRESERVATION OF AIRCRAFT WRECKAGE, MAIL, CARGO, AND RECORDS | B | Subpart B—Initial Notification of Aircraft Accidents, Incidents, and Overdue Aircraft | § 830.5 Immediate notification. | NTSB | [53 FR 36982, Sept. 23, 1988, as amended at 60 FR 40113, Aug. 7, 1995; 75 FR 927, Jan. 7, 2010; 75 FR 35330, June 22, 2010; 80 FR 77587, Dec. 15, 2015] | The operator of any civil aircraft, or any public aircraft not operated by the Armed Forces or an intelligence agency of the United States, or any foreign aircraft shall immediately, and by the most expeditious means available, notify the nearest National Transportation Safety Board (NTSB) office, 1 when: 1 NTSB headquarters is located at 490 L'Enfant Plaza SW., Washington, DC 20594. Contact information for the NTSB's regional offices is available at http://www.ntsb.gov. To report an accident or incident, you may call the NTSB Response Operations Center, at 844-373-9922 or 202-314-6290. (a) An aircraft accident or any of the following listed serious incidents occur: (1) Flight control system malfunction or failure; (2) Inability of any required flight crewmember to perform normal flight duties as a result of injury or illness; (3) Failure of any internal turbine engine component that results in the escape of debris other than out the exhaust path; (4) In-flight fire; (5) Aircraft collision in flight; (6) Damage to property, other than the aircraft, estimated to exceed $25,000 for repair (including materials and labor) or fair market value in the event of total loss, whichever is less. (7) For large multiengine aircraft (more than 12,500 pounds maximum certificated takeoff weight): (i) In-flight failure of electrical systems which requires the sustained use of an emergency bus powered by a back-up source such as a battery, auxiliary power unit, or air-driven generator to retain flight control or essential instruments; (ii) In-flight failure of hydraulic systems that results in sustained reliance on the sole remaining hydraulic or mechanical system for movement of flight control surfaces; (iii) Sustained loss of the power or thrust produced by two or more engines; and (iv) An evacuation of an aircraft in which an emergency egress system is utilized. (8) Release of all or a portion of a propeller blade from an aircraft, excluding release caused solely by ground contact; (9) A complete loss of … | ||||
| 49:49:7.1.4.1.12.2.1.2 | 49 | Transportation | VIII | 830 | PART 830—NOTIFICATION AND REPORTING OF AIRCRAFT ACCIDENTS OR INCIDENTS AND OVERDUE AIRCRAFT, AND PRESERVATION OF AIRCRAFT WRECKAGE, MAIL, CARGO, AND RECORDS | B | Subpart B—Initial Notification of Aircraft Accidents, Incidents, and Overdue Aircraft | § 830.6 Information to be given in notification. | NTSB | The notification required in § 830.5 shall contain the following information, if available: (a) Type, nationality, and registration marks of the aircraft; (b) Name of owner, and operator of the aircraft; (c) Name of the pilot-in-command; (d) Date and time of the accident; (e) Last point of departure and point of intended landing of the aircraft; (f) Position of the aircraft with reference to some easily defined geographical point; (g) Number of persons aboard, number killed, and number seriously injured; (h) Nature of the accident, the weather and the extent of damage to the aircraft, so far as is known; and (i) A description of any explosives, radioactive materials, or other dangerous articles carried. | |||||
| 49:49:7.1.4.1.12.3.1.1 | 49 | Transportation | VIII | 830 | PART 830—NOTIFICATION AND REPORTING OF AIRCRAFT ACCIDENTS OR INCIDENTS AND OVERDUE AIRCRAFT, AND PRESERVATION OF AIRCRAFT WRECKAGE, MAIL, CARGO, AND RECORDS | C | Subpart C—Preservation of Aircraft Wreckage, Mail, Cargo, and Records | § 830.10 Preservation of aircraft wreckage, mail, cargo, and records. | NTSB | (a) The operator of an aircraft involved in an accident or incident for which notification must be given is responsible for preserving to the extent possible any aircraft wreckage, cargo, and mail aboard the aircraft, and all records, including all recording mediums of flight, maintenance, and voice recorders, pertaining to the operation and maintenance of the aircraft and to the airmen until the Board takes custody thereof or a release is granted pursuant to § 831.12(b) of this chapter. (b) Prior to the time the Board or its authorized representative takes custody of aircraft wreckage, mail, or cargo, such wreckage, mail, or cargo may not be disturbed or moved except to the extent necessary: (1) To remove persons injured or trapped; (2) To protect the wreckage from further damage; or (3) To protect the public from injury. (c) Where it is necessary to move aircraft wreckage, mail or cargo, sketches, descriptive notes, and photographs shall be made, if possible, of the original positions and condition of the wreckage and any significant impact marks. (d) The operator of an aircraft involved in an accident or incident shall retain all records, reports, internal documents, and memoranda dealing with the accident or incident, until authorized by the Board to the contrary. | |||||
| 49:49:7.1.4.1.12.4.1.1 | 49 | Transportation | VIII | 830 | PART 830—NOTIFICATION AND REPORTING OF AIRCRAFT ACCIDENTS OR INCIDENTS AND OVERDUE AIRCRAFT, AND PRESERVATION OF AIRCRAFT WRECKAGE, MAIL, CARGO, AND RECORDS | D | Subpart D—Reporting of Aircraft Accidents, Incidents, and Overdue Aircraft | § 830.15 Reports and statements to be filed. | NTSB | [53 FR 36982, Sept. 23, 1988, as amended at 60 FR 40113, Aug. 7, 1995] | (a) Reports. The operator of a civil, public (as specified in § 830.5), or foreign aircraft shall file a report on Board Form 6120. 1/2 (OMB No. 3147-0001) 2 within 10 days after an accident, or after 7 days if an overdue aircraft is still missing. A report on an incident for which immediate notification is required by § 830.5(a) shall be filed only as requested by an authorized representative of the Board. 2 Forms are available from the Board field offices (see footnote 1), from Board headquarters in Washington, DC, and from the Federal Aviation Administration Flight Standards District Offices. (b) Crewmember statement. Each crewmember, if physically able at the time the report is submitted, shall attach a statement setting forth the facts, conditions, and circumstances relating to the accident or incident as they appear to him. If the crewmember is incapacitated, he shall submit the statement as soon as he is physically able. (c) Where to file the reports. The operator of an aircraft shall file any report with the field office of the Board nearest the accident or incident. |
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chapter TEXT,
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