The FDA published a final rule on Feb. 14, 2014, requiring manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive. 21, 2023]. (2) Submit annual reports (described in 803.33) to us. the hierarchy of the document. Importantly, mandatory submission of individual reports of death or serious injury events continues to be required, under sections 803.50 and 803.52, or 803.53, as applicable. 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; (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., 123456789020110001 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. 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. Where there was a high level of uncertainty regarding device risk. site when drafting amendatory language for Federal regulations: (Key terms are defined in 21 CFR 803.3.) As the frontline system for vaccine safety . You may also obtain information regarding voluntary reporting from the MedWatch office at 800FDA1088. You must report information required by 803.32. Search & Navigation If it is a followup report, you must include the report number of your initial report; (10) Event problem codespatient code and device code (refer to FDA MedWatch Medical Device Reporting Code Instructions); (13) Whether a report was sent to the manufacturer and the date it was sent (month, day, year); and. The site is secure. (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. Reports to manufacturers may be made in accordance with 803.11(b). The eCFR is displayed with paragraphs split and indented to follow (bb) Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of 830.20 of this chapter. In the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under 211.137, such written records shall be maintained for 3 years after distribution of the drug product. FDA Inspections-Complaint Investigation Requirements-Part I (1) Any information, including professional, scientific, or medical facts, observations, or opinions, may reasonably suggest that a device has caused or may have caused or contributed to an MDR reportable event. You must clearly identify the records as device incident records and file these records by device name. (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. You must submit the information required by 803.32. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Generally Applicable Requirements for Individual Adverse Event Reports. https://www.accessdata.fda.gov/scripts/medwatch/index.cfm, http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm, https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/mdr-adverse-event-codes, http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm. (1) The written record shall include the following information, where known: the name and strength of the drug product, lot number, name of complainant, nature of complaint, and reply to. Healthcare professionals within a user facility should familiarize themselves with their institution's procedures for reporting adverse events to the FDA. It is not an official legal edition of the CFR. The FDA published a final rule on Feb. 14, 2014, requiring manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive. The U.S. designated agent accepts responsibility for the duties that such designation entails. This content is from the eCFR and may include recent changes applied to the CFR. (3) If you are a manufacturer, you must submit MDR reports to us: (i) No later than 30 calendar days after the day that you become aware of information that reasonably suggests that a device may have caused or contributed to a death or serious injury or, (ii) No later than 30 calendar days after the day that you become aware of information that reasonably suggests a device 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; or. (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. VMSR Eligibility: Devices, manufacturers, or specific kinds of reportable device malfunctions are not eligible for VMSR in the following situations, as stated in the Federal Register on August 17, 2018 (83 FR 40973): In addition, as stated in the Federal Register notice, the FDA does not intend to consider devices under product codes in existence for less than 2 years to be eligible for the program, unless the new product code was issued solely for administrative reasons. (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. For instructions for medical device reporting for devices regulated as biological products by CBER, see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products. When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event? eCFR :: 21 CFR 820.198 -- Complaint files. (1) For purposes of this part, MDR event files are written or electronic files maintained by user facilities, importers, and manufacturers. Visit Mandatory Reporting Requirements: Manufacturers, Importers and Device User Facilities for specifics on requirements and associated processes. (c) If you are a user facility, you must submit reports of individual adverse events in accordance with 803.12(b) and 803.20. (b) You must clearly identify your annual report as such. The FDA's analysis of MDRs evaluates the totality of information provided in the initial MDR as well as any MDR supplemental reports subsequently provided. (vi) Where the report was submitted, i.e., to the manufacturer, importer, or us. Reports sent to the Agency must be submitted in accordance with the requirements of 803.12 (b). An outpatient treatment facility is covered by this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or whether it is accredited by a recognized accreditation organization. (m) Manufacturer or importer report number. (2) To submit a mandatory report in written form, a user facility must use Form FDA 3500A. CFR - Code of Federal Regulations Title 21 - Food and Drug Administration (e) If you are a manufacturer, you may maintain MDR event files as part of your complaint file, under part 820 of this chapter, if you prominently identify these records as MDR reportable events. (4) Systems that ensure access to information that facilitates timely followup and inspection by us. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Instructions for Downloading Viewers and Players. 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. (For example, the complete number will appear as follows: 1234567201100001.). (a) Each manufacturer shall maintain complaint files. Where can I find the reporting codes for adverse events that I use with medical device reports? 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. The importer must report only to the manufacturer if their imported devices have malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. You must submit the following: (2) Patient age at the time of event, or date of birth; (b) Adverse event or product problem (Form FDA 3500A, Block B). (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. Comments or questions about document content can not be answered by OFR staff. user convenience only and is not intended to alter agency intent [61 FR 52654, Oct. 7, 1996, as amended at 69 FR 11313, Mar. 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. You must keep in your MDR event files (described in 803.18) the information that the qualified person used to determine whether or not a device-related event was reportable. (c) Device information (Form FDA 3500A, Block D). FDA's Safety Reporting Requirements: Developing a Compliant - FDAnews If you are a medical device distributor, you must maintain records (files) of incidents, but you are not required to report these incidents. A user facility is not required to report a device malfunction, but can voluntarily advise the FDA of such product problems using the voluntary MedWatch Form FDA 3500 under theFDA's Safety Information and Adverse Event Reporting Program. Importers: Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury. For live medical advice, call the Poison Control Center: 1-800-222-1222. (1) The written record shall include the following information, where known: the name and strength of the drug product, lot number, name of complainant, nature of complaint, and reply to complainant. Find information and instructions for mandatory device reporting at: For Questions about Medical Device Reporting, including interpretation of MDR policy: Patients, healthcare professionals and consumers who find a problem related to a medical device are encouraged to report medical device adverse events or product problems to the FDA through MedWatch, the FDA Safety Information and Adverse Event Reporting Program. 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). (1) Name, address, and telephone number of the reporter who initially provided information to the manufacturer, user facility, or distributor; (e) Importer information (Form FDA 3500A, Block F). If the manufacturer is not known, you must submit the report to us. PART 211 -- CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS. Complaint files are linked to MDR event files because a complaint must be evaluated to determine if it is a reportable adverse event. Title 21 was last amended 6/22/2023. Outpatient treatment facilities include ambulance providers, rescue services, and home health care groups. WO Bldg. [79 FR 8846, Feb. 14, 2014, as amended at 85 FR 18441, Apr. 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. or existing codification. 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. The Medical Device Reporting (MDR) regulation ( 21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related. View the most recent official publication: These links go to the official, published CFR, which is updated annually. At 79 FR 8855, Feb. 14, 2014, 803.58 was stayed indefinitely. 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. (4) Is the U.S. agent of a foreign manufacturer. If I am an importer, what information must I submit in my individual adverse event reports? (d) You may submit a voluntary telephone report to the MedWatch office at 800FDA1088. (2) You are a manufacturer or importer and you did not manufacture or import the device about which you have adverse event information. (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. Medical Device Reports for Devices Licensed as Biological Products: For instructions for mandatory medical device reporting for licensed medical devices regulated as biological products by the Center for Biologics Evaluation and Research (CBER), see Submitting Medical Device Reports (MDRs) to CBER for Devices Licensed as Biological Products. If you did not perform an evaluation, you must explain why you did not perform an evaluation; (4) Device manufacture date (month, day, year); (5) Whether the device was labeled for single use; (6) Evaluation codes (including event codes, method of evaluation, result, and conclusion codes) (refer to FDA MedWatch Medical Device Reporting Code Instructions); (7) Whether remedial action was taken and the type of action; (8) Whether the use of the device was initial, reuse, or unknown; (9) Whether remedial action was reported as a removal or correction under section 519(f) of the Federal Food, Drug, and Cosmetic Act, and if it was, provide the correction/removal report number; and. The .gov means its official.Federal government websites often end in .gov or .mil. You must include the following information in your report, if reasonably known to you, as described in 803.30(b). 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. Language Assistance Available: Espaol | | Ting Vit | | Tagalog | | | Kreyl Ayisyen | Franais | Polski | Portugus | Italiano | Deutsch | | | English, The information on this page is current as of. 1 CFR 1.1 You may maintain these records in written or electronic format.