cfr_sections
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32 rows where part_number = 803 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 |
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| 21:21:8.0.1.1.3.1.1.1 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | A | Subpart A—General Provisions | § 803.1 What does this part cover? | FDA | (a) 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. (b) This part supplements and does not supersede other provisions of this chapter, including the provisions of part 820 of this chapter. (c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. | ||||
| 21:21:8.0.1.1.3.1.1.10 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | A | Subpart A—General Provisions | § 803.17 What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me? | FDA | If you are a user facility, importer, or manufacturer, you must develop, maintain, and implement written MDR procedures for the following: (a) Internal systems that provide for: (1) Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements; (2) A standardized review process or procedure for determining when an event meets the criteria for reporting under this part; and (3) Timely transmission of complete medical device reports to manufacturers or to us, or to both if required. (b) Documentation and recordkeeping requirements for: (1) Information that was evaluated to determine if an event was reportable; (2) All medical device reports and information submitted to manufacturers and/or us; (3) Any information that was evaluated for the purpose of preparing the submission of annual reports; and (4) Systems that ensure access to information that facilitates timely followup and inspection by us. | ||||
| 21:21:8.0.1.1.3.1.1.11 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | A | Subpart A—General Provisions | § 803.18 What are the requirements for establishing and maintaining MDR files or records that apply to me? | FDA | [79 FR 8846, Feb. 14, 2014, as amended at 90 FR 55979, Dec. 4, 2025] | (a) If you are a user facility, importer, or manufacturer, you must establish and maintain MDR event files. You must clearly identify all MDR event files and maintain them to facilitate timely access. (b)(1) For purposes of this part, “MDR event files” are written or electronic files maintained by user facilities, importers, and manufacturers. MDR event files may incorporate references to other information (e.g., medical records, patient files, engineering reports), in lieu of copying and maintaining duplicates in this file. Your MDR event files must contain: (i) Information in your possession or references to information related to the adverse event, including all documentation of your deliberations and decision making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable under this part; (ii) Copies of all reports submitted under this part (whether paper or electronic), and of all other information related to the event that you submitted to us or other entities such as an importer, distributor, or manufacturer; and (iii) Copies of all electronic acknowledgments FDA sends you in response to electronic MDR submissions. (2) If you are a user facility, importer, or manufacturer, you must permit any authorized FDA employee, at all reasonable times, to access, to copy, and to verify the records required by this part. (c) If you are a user facility, you must retain an MDR event file relating to an adverse event for a period of 2 years from the date of the event. If you are a manufacturer or importer, you must retain an MDR event file relating to an adverse event for a period of 2 years from the date of the event or a period of time equivalent to the expected life of the device, whichever is greater. If the device is no longer distributed, you still must maintain MDR event files for the time periods described in this paragraph (c). (d)(1) If you are a device distributor, you must establish and maintain device complaint records (files). Your records must c… | |||
| 21:21:8.0.1.1.3.1.1.12 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | A | Subpart A—General Provisions | § 803.19 Are there exemptions, variances, or alternative forms of adverse event reporting requirements? | FDA | [79 FR 8846, Feb. 14, 2014, as amended at 85 FR 18441, Apr. 2, 2020; 88 FR 16879, Mar. 21, 2023] | (a) We exempt the following persons from the adverse event reporting requirements in this part: (1) A licensed practitioner who prescribes or administers devices intended for use in humans and manufactures or imports devices solely for use in diagnosing and treating persons with whom the practitioner has a “physician-patient” relationship; (2) An individual who manufactures devices intended for use in humans solely for this person's use in research or teaching and not for sale. This includes any person who is subject to alternative reporting requirements under the investigational device exemption regulations (described in part 812 of this chapter), which require reporting of all adverse device effects; and (3) Dental laboratories or optical laboratories. (b) If you are a manufacturer, importer, or user facility, you may request an exemption or variance from any or all of the reporting requirements in this part, including the requirements of § 803.12. You must submit the request to the Center for Devices and Radiological Health (CDRH) in writing at MDRPolicy@fda.hhs.gov . Your request must include information necessary to identify you and the device; a complete statement of the request for exemption, variance, or alternative reporting; and an explanation why your request is justified. If you are requesting an exemption from the requirement to submit reports to FDA in electronic format under § 803.12(a), your request should indicate for how long you will require this exemption. (c) If you are a manufacturer, importer, or user facility, we may grant in writing an exemption or variance from, or alternative to, any or all of the reporting requirements in this part, and may change the frequency of reporting to quarterly, semiannually, annually or other appropriate time period. We may grant these modifications in response to your request, as described in paragraph (b) of this section, or at our discretion. When we grant modifications to the reporting requirements, we may impose other reporting requirements to ensu… | |||
| 21:21:8.0.1.1.3.1.1.2 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | A | Subpart A—General Provisions | § 803.3 How does FDA define the terms used in this part? | FDA | [79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015] | Some of the terms we use in this part are specific to medical device reporting and reflect the language used in the statute (law). Other terms are more general and reflect our interpretation of the law. This section defines the following terms as used in this part: (a) Ambulatory surgical facility (ASF) means a distinct entity that operates for the primary purpose of furnishing same day outpatient surgical services to patients. An ASF may be either an independent entity (i.e., not a part of a provider of services or any other facility) or operated by another medical entity (e.g., under the common ownership, licensure, or control of an entity). An ASF is subject to this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or regardless of whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the ASF must report that event regardless of the nature or location of the medical service provided by the ASF. (b) Become aware means that an employee of the entity required to report has acquired information that reasonably suggests a reportable adverse event has occurred. (1) If you are a device user facility, you are considered to have “become aware” when medical personnel, as defined in this section, who are employed by or otherwise formally affiliated with your facility, obtain information about a reportable event. (2) If you are a manufacturer, you are considered to have become aware of an event when any of your employees becomes aware of a reportable event that is required to be reported within 30 calendar days or that is required to be reported within 5 work days because we had requested reports in accordance with § 803.53(b). You are also considered to have become aware of an event when any of your employees with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or whose duties relate to the collection and reporting of adverse eve… | |||
| 21:21:8.0.1.1.3.1.1.3 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | A | Subpart A—General Provisions | § 803.9 What information from the reports do we disclose to the public? | FDA | (a) We may disclose to the public any report, including any FDA record of a telephone report, submitted under this part. Our disclosures are governed by part 20 of this chapter. (b) Before we disclose a report to the public, we will delete the following: (1) Any information that constitutes trade secret or confidential commercial or financial information under § 20.61 of this chapter; (2) Any personal, medical, and similar information, including the serial number of implanted devices, which would constitute an invasion of personal privacy under § 20.63 of this chapter. However, if a patient requests a report, we will disclose to that patient all the information in the report concerning that patient, as provided in § 20.61 of this chapter; and (3) Any names and other identifying information of a third party that voluntarily submitted an adverse event report. (c) We may not disclose the identity of a device user facility that makes a report under this part except in connection with: (1) An action brought to enforce section 301(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)), including the failure or refusal to furnish material or information required by section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i)); (2) A communication to a manufacturer of a device that is the subject of a report required to be submitted by a user facility under § 803.30; or (3) A disclosure to employees of the Department of Health and Human Services, to the Department of Justice, or to the duly authorized committees and subcommittees of the Congress. | ||||
| 21:21:8.0.1.1.3.1.1.4 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | A | Subpart A—General Provisions | § 803.10 Generally, what are the reporting requirements that apply to me? | FDA | (a) If you are a device user facility, you must submit reports (described in subpart C of this part), as follows: (1) Submit reports of individual adverse events no later than 10 work days after the day that you become aware of a reportable event: (i) Submit reports of device-related deaths to us and to the manufacturer, if known, or (ii) Submit reports of device-related serious injuries to the manufacturers or, if the manufacturer is unknown, submit reports to us. (2) Submit annual reports (described in § 803.33) to us. (b) If you are an importer, you must submit reports (described in subpart D of this part), as follows: (1) Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable event: (i) Submit reports of device-related deaths or serious injuries to us and to the manufacturer or (ii) Submit reports of device-related malfunctions to the manufacturer. (2) [Reserved] (c) If you are a manufacturer, you must submit reports (described in subpart E of this part) to us, as follows: (1) Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable death, serious injury, or malfunction. (2) Submit reports of individual adverse events no later than 5 work days after the day that you become aware of: (i) A reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health or (ii) A reportable event for which we made a written request. (3) Submit supplemental reports if you obtain information that you did not submit in an initial report. | ||||
| 21:21:8.0.1.1.3.1.1.5 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | A | Subpart A—General Provisions | § 803.11 What form should I use to submit reports of individual adverse events and where do I obtain these forms? | FDA | [79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015; 85 FR 18441, Apr. 2, 2020] | (a) If you are a manufacturer or importer, you must submit reports of individual adverse events to FDA in an electronic format in accordance with § 803.12(a) and § 803.20, unless granted an exemption under § 803.19. (b) Importer reports submitted to device manufacturers may be in paper format or an electronic format that includes all required data fields to ensure that the manufacturer has all required information. (c) If you are a user facility, you must submit reports of individual adverse events in accordance with § 803.12(b) and § 803.20. (d) Form FDA 3500A is available on the internet at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm. | |||
| 21:21:8.0.1.1.3.1.1.6 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | A | Subpart A—General Provisions | § 803.12 How do I submit initial and supplemental or followup reports? | FDA | (a) Manufacturers and importers must submit initial and supplemental or followup reports to FDA in an electronic format that FDA can process, review, and archive. (b) User facilities that submit their reports and additional information to FDA electronically must use an electronic format that FDA can process, review, and archive. User facilities that submit their reports to FDA on paper must submit any written report or additional information required under this part to FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002, using Form FDA 3500A. Each report must be identified (e.g., “User Facility Report” or “Annual Report”). (c) If you are confronted with a public health emergency, this can be brought to FDA's attention by contacting FDA's Office of Crisis Management, Emergency Operations Center by telephone, 24-hours a day, at 301-796-8240 or toll free at 866-300-4374, followed by the submission of an email to: emergency.operations@fda.hhs.gov . This action does not satisfy your obligation to report under part 803. (d) You may submit a voluntary telephone report to the MedWatch office at 800-FDA-1088. You may also obtain information regarding voluntary reporting from the MedWatch office at 800-FDA-1088. You may also find the voluntary Form FDA 3500 and instructions to complete it at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm. | ||||
| 21:21:8.0.1.1.3.1.1.7 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | A | Subpart A—General Provisions | § 803.13 Do I need to submit reports in English? | FDA | Yes. You must submit all reports required by this part in English. | ||||
| 21:21:8.0.1.1.3.1.1.8 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | A | Subpart A—General Provisions | § 803.15 How will I know if you require more information about my medical device report? | FDA | (a) We will notify you in writing if we require additional information and will tell you what information we need. We will require additional information if we determine that protection of the public health requires additional or clarifying information for medical device reports submitted to us and in cases when the additional information is beyond the scope of FDA reporting forms or is not readily accessible to us. (b) In any request under this section, we will state the reason or purpose for the information request, specify the due date for submitting the information, and clearly identify the reported event(s) related to our request. If we verbally request additional information, we will confirm the request in writing. | ||||
| 21:21:8.0.1.1.3.1.1.9 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | A | Subpart A—General Provisions | § 803.16 When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event? | FDA | No. A report or other information submitted by you, and our release of that report or information, is not necessarily an admission that the device, or you or your employees, caused or contributed to the reportable event. You do not have to admit and may deny that the report or information submitted under this part constitutes an admission that the device, you, or your employees, caused or contributed to a reportable event. | ||||
| 21:21:8.0.1.1.3.2.1.1 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | B | Subpart B—Generally Applicable Requirements for Individual Adverse Event Reports | § 803.20 How do I complete and submit an individual adverse event report? | FDA | (a) What form must I complete and submit ? (1) If you are a health professional or consumer or other entity, you may submit voluntary reports to FDA regarding devices or other FDA-regulated products using the Form FDA 3500. (2) To submit a mandatory report in written form, a user facility must use Form FDA 3500A. (3) An electronic submission of a mandatory report from a user facility, importer, or manufacturer must contain the information from the applicable blocks of Form FDA 3500A. All electronic submissions must include information about the patient, the event, the device, and the “initial reporter.” An electronic submission from a user facility or importer must include the information from block F. An electronic submission from a manufacturer must include the information from blocks G and H. If you are a manufacturer and you receive a report from a user facility or importer, you must incorporate that information in your electronic submission and include any corrected or missing information. (b) To whom must I submit reports and when ? (1) If you are a user facility, you must submit MDR reports to: (i) The manufacturer and to us no later than 10 work days after the day that you become aware of information that reasonably suggests that a device has or may have caused or contributed to a death or (ii) The manufacturer no later than 10 work days after the day that you become aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury. If the manufacturer is not known, you must submit this report to us. (2) If you are an importer, you must submit MDR reports to: (i) The manufacturer and to us, no later than 30 calendar days after the day that you become aware of information that reasonably suggests that a device has or may have caused or contributed to a death or serious injury or (ii) The manufacturer, no later than 30 calendar days after receiving information that a device you market has malfunctioned and that this device or a similar device t… | ||||
| 21:21:8.0.1.1.3.2.1.2 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | B | Subpart B—Generally Applicable Requirements for Individual Adverse Event Reports | § 803.21 Where can I find the reporting codes for adverse events that I use with medical device reports? | FDA | [79 FR 8846, Feb. 14, 2014, as amended at 85 FR 18441, Apr. 2, 2020] | (a) The MedWatch Medical Device Reporting Code Instruction Manual contains adverse event codes for use with Form FDA 3500A. You may obtain the coding manual from FDA's website at: https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes. (b) We may sometimes use additional coding of information on the reporting forms or modify the existing codes. If we do make modifications, we will ensure that we make the new coding information available to all reporters. | |||
| 21:21:8.0.1.1.3.2.1.3 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | B | Subpart B—Generally Applicable Requirements for Individual Adverse Event Reports | § 803.22 What are the circumstances in which I am not required to file a report? | FDA | (a) If you become aware of information from multiple sources regarding the same patient and same reportable event, you may submit one medical device report. (b) You are not required to submit a medical device report if: (1) You are a user facility, importer, or manufacturer, and you determine that the information received is erroneous in that a device-related adverse event did not occur. You must retain documentation of these reports in your MDR files for the time periods specified in § 803.18. (2) You are a manufacturer or importer and you did not manufacture or import the device about which you have adverse event information. When you receive reportable event information in error, you must forward this information to us with a cover letter explaining that you did not manufacture or import the device in question. | ||||
| 21:21:8.0.1.1.3.2.1.4 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | B | Subpart B—Generally Applicable Requirements for Individual Adverse Event Reports | § 803.23 Where can I find information on how to prepare and submit an MDR in electronic format? | FDA | (a) You may obtain information on how to prepare and submit reports in an electronic format that FDA can process, review, and archive at: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm . (b) We may sometimes update information on how to prepare and submit reports electronically. If we do make modifications, we will ensure that we alert reporters by updating the eMDR Web page. | ||||
| 21:21:8.0.1.1.3.3.1.1 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | C | Subpart C—User Facility Reporting Requirements | § 803.30 If I am a user facility, what reporting requirements apply to me? | FDA | (a) You must submit reports to the manufacturer or to us, or both, as specified in paragraphs (a)(1) and (a)(2) of this section as follows: (1) Reports of death. You must submit a report to us as soon as practicable but no more than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility. You must also submit the report to the device manufacturer, if known. You must submit the information required by § 803.32. Reports sent to the Agency must be submitted in accordance with the requirements of § 803.12(b). (2) Reports of serious injury. You must submit a report to the manufacturer of the device no later than 10 work days after the day that you become aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of your facility. If the manufacturer is not known, you must submit the report to us. You must report information required by § 803.32. Reports sent to the Agency must be submitted in accordance with the requirements of § 803.12 (b). (b) What information does FDA consider “reasonably known” to me? You must submit all information required in this subpart C that is reasonably known to you. This information includes information found in documents that you possess and any information that becomes available as a result of reasonable followup within your facility. You are not required to evaluate or investigate the event by obtaining or evaluating information that you do not reasonably know. | ||||
| 21:21:8.0.1.1.3.3.1.2 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | C | Subpart C—User Facility Reporting Requirements | § 803.32 If I am a user facility, what information must I submit in my individual adverse event reports? | FDA | [79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015] | You must include the following information in your report, if reasonably known to you, as described in § 803.30(b). These types of information correspond generally to the elements of Form FDA 3500A: (a) Patient information (Form FDA 3500A, Block A). You must submit the following: (1) Patient name or other identifier; (2) Patient age at the time of event, or date of birth; (3) Patient gender; and (4) Patient weight. (b) Adverse event or product problem (Form FDA 3500A, Block B). You must submit the following: (1) Identification of adverse event or product problem; (2) Outcomes attributed to the adverse event (e.g., death or serious injury). An outcome is considered a serious injury if it is: (i) A life-threatening injury or illness; (ii) A disability resulting in permanent impairment of a body function or permanent damage to a body structure; or (iii) An injury or illness that requires intervention to prevent permanent impairment of a body structure or function; (3) Date of event; (4) Date of this report; (5) Description of event or problem, including a discussion of how the device was involved, nature of the problem, patient followup or required treatment, and any environmental conditions that may have influenced the event; (6) Description of relevant tests, including dates and laboratory data; and (7) Description of other relevant history, including preexisting medical conditions. (c) Device information (Form FDA 3500A, Block D). You must submit the following: (1) Brand name; (2) Product Code, if known, and Common Device Name; (3) Manufacturer name, city, and state; (4) Model number, catalog number, serial number, lot number, or other identifying number; expiration date; and unique device identifier (UDI) that appears on the device label or on the device package; (5) Operator of the device (health professional, lay user/patient, other); (6) Date of device implantation (month, day, year), if applicable; (7) Date of device explantation (month, day, year), if applicable; (8) Whether the dev… | |||
| 21:21:8.0.1.1.3.3.1.3 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | C | Subpart C—User Facility Reporting Requirements | § 803.33 If I am a user facility, what must I include when I submit an annual report? | FDA | [79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015; 85 FR 18442, Apr. 2, 2020] | (a) You must submit to us an annual report on Form FDA 3419. You must submit an annual report by January 1, of each year. You may obtain this form on the internet at: https://www.fda.gov/media/72292/download. (b) You must clearly identify your annual report as such. You must submit your annual report to FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002. Your annual report must include: (1) Your CMS provider number used for medical device reports, or the number assigned by us for reporting purposes in accordance with § 803.3; (2) Reporting year; (3) Your name and complete address; (4) Total number of reports attached or summarized; (5) Date of the annual report and report numbers identifying the range of medical device reports that you submitted during the report period (e.g., 1234567890-2011-0001 through 1000); (6) Name, position title, and complete address of the individual designated as your contact person responsible for reporting to us and whether that person is a new contact for you; and (7) Information for each reportable event that occurred during the annual reporting period including: (i) Report number; (ii) Name and address of the device manufacturer; (iii) Device brand name and common name; (iv) Product model, catalog, serial, and lot number and unique device identifier (UDI) that appears on the device label or on the device package; (v) A brief description of the event reported to the manufacturer and/or us; and (vi) Where the report was submitted, i.e., to the manufacturer, importer, or us. (c) In lieu of submitting the information in paragraph (b)(7) of this section, you may submit a copy of each medical device report that you submitted to the manufacturers and/or to us during the reporting period. (d) If you did not submit any medical device reports to manufacturers or us during the time period, you do not need to submit an annual report. | |||
| 21:21:8.0.1.1.3.4.1.1 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | D | Subpart D—Importer Reporting Requirements | § 803.40 If I am an importer, what reporting requirements apply to me? | FDA | (a) Reports of deaths or serious injuries. You must submit a report to us, and a copy of this report to the manufacturer, as soon as practicable, but no later than 30 calendar days after the day that you receive or otherwise become aware of information from any source, including user facilities, individuals, or medical or scientific literature, whether published or unpublished, that reasonably suggests that one of your marketed devices may have caused or contributed to a death or serious injury. You must submit the information required by § 803.42. Reports sent to the Agency must be submitted in accordance with the requirements of § 803.12(a). (b) Reports of malfunctions. You must submit a report to the manufacturer as soon as practicable but no later than 30 calendar days after the day that you receive or otherwise become aware of information from any source, including user facilities, individuals, or through your own research, testing, evaluation, servicing, or maintenance of one of your devices, that reasonably suggests that one of your devices has malfunctioned and that this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. You must submit the information required by § 803.42. Reports to manufacturers may be made in accordance with § 803.11(b). | ||||
| 21:21:8.0.1.1.3.4.1.2 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | D | Subpart D—Importer Reporting Requirements | § 803.42 If I am an importer, what information must I submit in my individual adverse event reports? | FDA | [79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015] | You must include the following information in your report, if the information is known or should be known to you, as described in § 803.40. These types of information correspond generally to the format of Form FDA 3500A: (a) Patient information (Form FDA 3500A, Block A). You must submit the following: (1) Patient name or other identifier; (2) Patient age at the time of event, or date of birth; (3) Patient gender; and (4) Patient weight. (b) Adverse event or product problem (Form FDA 3500A, Block B). You must submit the following: (1) Identification of adverse event or product problem; (2) Outcomes attributed to the adverse event (e.g., death or serious injury). An outcome is considered a serious injury if it is: (i) A life-threatening injury or illness; (ii) A disability resulting in permanent impairment of a body function or permanent damage to a body structure; or (iii) An injury or illness that requires intervention to prevent permanent impairment of a body structure or function; (3) Date of event; (4) Date of this report; (5) Description of the event or problem, including a discussion of how the device was involved, nature of the problem, patient followup or required treatment, and any environmental conditions that may have influenced the event; (6) Description of relevant tests, including dates and laboratory data; and (7) Description of other relevant patient history, including preexisting medical conditions. (c) Device information (Form FDA 3500A, Block D). You must submit the following: (1) Brand name; (2) Product Code, if known, and Common Device Name; (3) Manufacturer name, city, and state; (4) Model number, catalog number, serial number, lot number, or other identifying number; expiration date; and unique device identifier (UDI) that appears on the device label or on the device package; (5) Operator of the device (health professional, lay user/patient, other); (6) Date of device implantation (month, day, year), if applicable; (7) Date of device explanation (month, day, year), if… | |||
| 21:21:8.0.1.1.3.5.1.1 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | E | Subpart E—Manufacturer Reporting Requirements | § 803.50 If I am a manufacturer, what reporting requirements apply to me? | FDA | (a) If you are a manufacturer, you must report to us the information required by § 803.52 in accordance with the requirements of § 803.12(a), no later than 30 calendar days after the day that you receive or otherwise become aware of information, from any source, that reasonably suggests that a device that you market: (1) May have caused or contributed to a death or serious injury or (2) Has malfunctioned and this device or a similar device that you market would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. (b) What information does FDA consider “reasonably known” to me? (1) You must submit all information required in this subpart E that is reasonably known to you. We consider the following information to be reasonably known to you: (i) Any information that you can obtain by contacting a user facility, importer, or other initial reporter; (ii) Any information in your possession; or (iii) Any information that you can obtain by analysis, testing, or other evaluation of the device. (2) You are responsible for obtaining and submitting to us information that is incomplete or missing from reports submitted by user facilities, importers, and other initial reporters. (3) You are also responsible for conducting an investigation of each event and evaluating the cause of the event. If you cannot submit complete information on a report, you must provide a statement explaining why this information was incomplete and the steps you took to obtain the information. If you later obtain any required information that was not available at the time you filed your initial report, you must submit this information in a supplemental report under § 803.56 in accordance with the requirements of § 803.12(a). | ||||
| 21:21:8.0.1.1.3.5.1.2 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | E | Subpart E—Manufacturer Reporting Requirements | § 803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports? | FDA | [79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015] | You must include the following information in your reports, if known or reasonably known to you, as described in § 803.50(b). These types of information correspond generally to the format of Form FDA 3500A: (a) Patient information (Form FDA 3500A, Block A). You must submit the following: (1) Patient name or other identifier; (2) Patient age at the time of event, or date of birth; (3) Patient gender; and (4) Patient weight. (b) Adverse event or product problem (Form FDA 3500A, Block B). You must submit the following: (1) Identification of adverse event or product problem; (2) Outcomes attributed to the adverse event (e.g., death or serious injury). An outcome is considered a serious injury if it is: (i) A life-threatening injury or illness; (ii) A disability resulting in permanent impairment of a body function or permanent damage to a body structure; or (iii) An injury or illness that requires intervention to prevent permanent impairment of a body structure or function; (3) Date of event; (4) Date of this report; (5) Description of the event or problem, including a discussion of how the device was involved, nature of the problem, patient followup or required treatment, and any environmental conditions that may have influenced the event; (6) Description of relevant tests, including dates and laboratory data; and (7) Other relevant patient history including preexisting medical conditions. (c) Device information (Form FDA 3500A, Block D). You must submit the following: (1) Brand name; (2) Product Code, if known, and Common Device Name; (3) Manufacturer name, city, and state; (4) Model number, catalog number, serial number, lot number, or other identifying number; expiration date; and unique device identifier (UDI) that appears on the device label or on the device package; (5) Operator of the device (health professional, lay user/patient, other); (6) Date of device implantation (month, day, year), if applicable; (7) Date of device explantation (month, day, year), if applicable; (8) Whether the… | |||
| 21:21:8.0.1.1.3.5.1.3 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | E | Subpart E—Manufacturer Reporting Requirements | § 803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report? | FDA | You must submit a 5-day report to us with the information required by § 803.52 in accordance with the requirements of § 803.12(a) no later than 5 work days after the day that you become aware that: (a) An MDR reportable event necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health. You may become aware of the need for remedial action from any information, including any trend analysis or (b) We have made a written request for the submission of a 5-day report. If you receive such a written request from us, you must submit, without further requests, a 5-day report for all subsequent events of the same nature that involve substantially similar devices for the time period specified in the written request. We may extend the time period stated in the original written request if we determine it is in the interest of the public health. | ||||
| 21:21:8.0.1.1.3.5.1.4 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | E | Subpart E—Manufacturer Reporting Requirements | § 803.56 If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports? | FDA | If you are a manufacturer, when you obtain information required under this part that you did not provide because it was not known or was not available when you submitted the initial report, you must submit the supplemental information to us within 30 calendar days of the day that you receive this information. You must submit the supplemental or followup report in accordance with the requirements of § 803.12(a). On a supplemental or followup report, you must: (a) Indicate that the report being submitted is a supplemental or followup report; (b) Submit the appropriate identification numbers of the report that you are updating with the supplemental information (e.g., your original manufacturer report number and the user facility or importer report number of any report on which your report was based), if applicable; and (c) Include only the new, changed, or corrected information. | ||||
| 21:21:8.0.1.1.3.5.1.5 | 21 | Food and Drugs | I | H | 803 | PART 803—MEDICAL DEVICE REPORTING | E | Subpart E—Manufacturer Reporting Requirements | § 803.58 Foreign manufacturers. | FDA | (a) Every foreign manufacturer whose devices are distributed in the United States shall designate a U.S. agent to be responsible for reporting in accordance with § 807.40 of this chapter. The U.S. designated agent accepts responsibility for the duties that such designation entails. Upon the effective date of this regulation, foreign manufacturers shall inform FDA, by letter, of the name and address of the U.S. agent designated under this section and § 807.40 of this chapter, and shall update this information as necessary. Such updated information shall be submitted to FDA, within 5 days of a change in the designated agent information. (b) U.S.-designated agents of foreign manufacturers are required to: (1) Report to FDA in accordance with §§ 803.50, 803.52, 803.53, and 803.56; (2) Conduct, or obtain from the foreign manufacturer the necessary information regarding, the investigation and evaluation of the event to comport with the requirements of § 803.50; (3) Forward MDR complaints to the foreign manufacturer and maintain documentation of this requirement; (4) Maintain complaint files in accordance with § 803.18; and (5) Register, list, and submit premarket notifications in accordance with part 807 of this chapter. | ||||
| 28:28:2.0.6.5.4.0.127.1 | 28 | Judicial Administration | VIII | 803 | PART 803—AGENCY SEAL | § 803.1 Description. | CSOSA | [69 FR 21059, Apr. 20, 2004, as amended at 77 FR 59082, Sept. 26, 2012] | (a) The Agency seal of the Court Services and Offender Supervision Agency for the District of Columbia (CSOSA or Agency) is described as follows: General George Washington's coat of arms in red and white bounded by an outline of the District of Columbia and superimposed upon a blue field together with the dome of the United States Capitol building in gold; encircled by a banner with the words “Community, Accountability, and Justice” and gold laurel branches, with gold edges bearing the inscription “COURT SERVICES AND OFFENDER SUPERVISION AGENCY” above three stars at either side of the words “DISTRICT OF COLUMBIA” in smaller letters in the base; letters and stars in gold. A reproduction of the Agency seal in black and white appears as follows. (b) The Agency seal of the Pretrial Services Agency for the District of Columbia (PSA or Agency) is described as follows: Two crossed flags, the United States flag on the left and the District of Columbia flag on the right superimposed upon the United States Capitol dome and two laurel branches both in gold which appear on a blue field bearing a white banner edged and lettered in gold with the inscription “COMMUNITY, ACCOUNTABILITY, JUSTICE”; bearing the inscription “PRETRIAL SERVICES AGENCY” at the top, and “DISTRICT OF COLUMBIA” at the bottom surrounded by three gold stars on either side; letters and stars in gold. A reproduction of the Agency seal in black and white appears below. | ||||||
| 28:28:2.0.6.5.4.0.127.2 | 28 | Judicial Administration | VIII | 803 | PART 803—AGENCY SEAL | § 803.2 Authority to affix seal. | CSOSA | [77 FR 59082, Sept. 26, 2012] | The Director of CSOSA or PSA (as appropriate) and each Director's designees are authorized to affix their respective Agency seal (including replicas and reproductions) to appropriate documents, certifications, and other materials for all purposes authorized by this part. | ||||||
| 28:28:2.0.6.5.4.0.127.3 | 28 | Judicial Administration | VIII | 803 | PART 803—AGENCY SEAL | § 803.3 Use of the seal. | CSOSA | [69 FR 21059, Apr. 20, 2004, as amended at 77 FR 59082, Sept. 26, 2012] | (a) Each Agency's seal is used by that Agency's staff for official Agency business as approved by the appropriate Director or designee in accordance with all subparts of 28 CFR 803.3. (b) Use of the Agency seal by any person or organization outside of the Agency may be made only with the appropriate prior written approval. (1) Any request for such use must be made in writing to the Office of the General Counsel, Court Services and Offender Supervision Agency for the District of Columbia, 633 Indiana Avenue, NW., Washington, DC 20004, and must specify, in detail, the exact use to be made. Any permission granted by the appropriate Director or designee applies only to the specific use for which it was granted and is not to be construed as permission for any other use. (2) The decision whether to grant such a request is made on a case-by-case basis, with consideration of all relevant factors, which may include: the benefit or cost to the government of granting the request; the unintended appearance of endorsement or authentication by the Agency; the potential for misuse; the effect upon Agency security; the reputability of the use; the extent of the control by the Agency over the ultimate use; and the extent of control by the Agency over distribution of any products or publications bearing the Agency seal. (c) Falsely making, forging, counterfeiting, mutilating, or altering the Agency seal or reproduction, or knowingly using or possessing with fraudulent intent an altered Agency seal or reproduction is punishable under 28 U.S.C. 506. (d) Any person using the Agency seal or reproduction in a manner inconsistent with the provisions of this part is subject to the provisions of 18 U.S.C. 1017, which states penalties for the wrongful use of an Agency seal, and other provisions of law as applicable. | ||||||
| 49:49:7.1.4.1.4.0.1.1 | 49 | Transportation | VIII | 803 | PART 803—OFFICIAL SEAL | § 803.1 Description. | NTSB | [88 FR 69044, Oct. 5, 2023] | The official seal of the National Transportation Safety Board (NTSB) is described as follows: An American bald eagle with wings displayed, holding an olive branch in its right talon and a bundle of 13 arrows in its left talon. Above the eagle's head is a white scroll inscribed “E Pluribus Unum” in black. The eagle bears a shield that resembles the United States flag with vertical stripes of alternating white and red and a blue top; all are within an encircling inscription, “National Transportation Safety Board”. The eagle's wings, body, and upper portion of the legs are shades of brown. The head, neck, and tail are white. The beak, lower portion of the legs, feet, arrows, olive branch, and encircling inscription are gold. When the full color seal is illustrated on print or digital media, the background of the seal must be white. When the full color seal is embroidered on official NTSB uniform items, the seal's background must be the color of the material. When the monochrome seal is used on print or digital media, the seal can be displayed in black, blue, or in white on contrasting background. When used on official NTSB uniform items, the monochrome seal can be illustrated in yellow-gold on navy blue material. The monochrome version of the NTSB's official seal appears in Figure 1. | ||||||
| 49:49:7.1.4.1.4.0.1.2 | 49 | Transportation | VIII | 803 | PART 803—OFFICIAL SEAL | § 803.3 Authority to affix Seal. | NTSB | [40 FR 30238, July 17, 1975, as amended at 41 FR 39758, Sept. 16, 1976; 81 FR 75731, Nov. 1, 2016; 88 FR 69045, Oct. 5, 2023] | (a) The Seal shall be in the custody and control of the Chief Human Capital Officer of the Board. (b) The Chief Human Capital Officer may delegate and authorize redelegations of this authority. | ||||||
| 49:49:7.1.4.1.4.0.1.3 | 49 | Transportation | VIII | 803 | PART 803—OFFICIAL SEAL | § 803.5 Use of the Seal. | NTSB | [40 FR 30238, July 17, 1975, as amended at 41 FR 39758, Sept. 16, 1976; 81 FR 775731, Nov. 1, 2016; 88 FR 69045, Oct. 5, 2023] | (a) The Seal is the official emblem of the Board and its use is therefore permitted only as provided in this part. (b) Use by any person or organization outside of the Board may be made only with the Board's prior written approval. (c) Requests by any person or organization outside of the Board for permission to use the Seal must be made in writing to Chief Human Capital Officer, National Transportation Safety Board, 490 L'Enfant Plaza, SW., Washington, DC 20594. The request must specify in detail the exact use to be made. Any permission granted shall apply only to the specific use for which it was granted. (d) Use of the Seal shall be essentially for informational purposes. The Seal may not be used on any article or in any manner which may discredit the Seal or reflect unfavorably upon the Board, or which implies Board endorsement of commercial products or services, or of the user's or users' policies or activities. Specifically, permission may not be granted under this section for nonofficial use— (1) On souvenir or novelty items of an expendable nature; (2) On toys, gifts, or premiums; (3) As a letterhead design; (4) On menus, matchbook covers, calendars, or similar items; (5) To adorn civilian clothing; or (6) On athletic clothing or equipment. (e) Where necessary to avoid any prohibited implication or confusion as to the Board's association with the user or users, an appropriate legend will be prescribed by the Board for prominent display in connection with the permitted use. (f) Falsely making, forging, counterfeiting, mutilating, or altering the Seal, or knowingly using or possessing with fraudulent intent any altered Seal is punishable under section 506 of Title 18, U.S.C. |
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CREATE TABLE cfr_sections (
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title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
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CREATE INDEX idx_cfr_agency ON cfr_sections(agency);