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  • CFR - Code of Federal Regulations Title 21

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    Atul Gaikwad
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    The document outlines FDA regulations for medical device complaint files as outlined in the Code of Federal Regulations Title 21. It states that manufacturers must establish procedures to receive, review, evaluate, and investigate complaints in a timely and uniform manner. All complaints must be documented and evaluated to determine if they require reporting to the FDA. Records of complaints and any investigations must be maintained.

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    CFR - Code of Federal Regulations Title 21

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    The document outlines FDA regulations for medical device complaint files as outlined in the Code of Federal Regulations Title 21. It states that manufacturers must establish procedures to receive, review, evaluate, and investigate complaints in a timely and uniform manner. All complaints must be documented and evaluated to determine if they require reporting to the FDA. Records of complaints and any investigations must be maintained.

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    9 views3 pages

    CFR - Code of Federal Regulations Title 21

    Uploaded by

    Atul Gaikwad
    The document outlines FDA regulations for medical device complaint files as outlined in the Code of Federal Regulations Title 21. It states that manufacturers must establish procedures to receive, review, evaluate, and investigate complaints in a timely and uniform manner. All complaints must be documented and evaluated to determine if they require reporting to the FDA. Records of complaints and any investigations must be maintained.

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    FDA Home3 Medical Devices4 Databases5

    CFR - Code of Federal Regulations Title 21


    The information on this page is current as of Oct 17, 2023.
    For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).6

    New Search Help7 | More About 21CFR 8


    [Code of Federal Regulations]
    [Title 21, Volume 8] 9
    [CITE: 21CFR820.198]

    TITLE 21--FOOD AND DRUGS


    CHAPTER I--FOOD AND DRUG ADMINISTRATION
    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    SUBCHAPTER H - MEDICAL DEVICES
    PART 820 -- QUALITY SYSTEM REGULATION
    Subpart M - Records
    Sec. 820.198 Complaint files.

    (a) Each manufacturer shall maintain complaint files. Each manufacturer shall
    establish and maintain procedures for receiving, reviewing, and evaluating
    complaints by a formally designated unit. Such procedures shall ensure that:
    (1) All complaints are processed in a uniform and timely manner;
    (2) Oral complaints are documented upon receipt; and
    (3) Complaints are evaluated to determine whether the complaint represents an
    event which is required to be reported to FDA under part 803 of this chapter,
    Medical Device Reporting.
    (b) Each manufacturer shall review and evaluate all complaints to determine
    whether an investigation is necessary. When no investigation is made, the
    manufacturer shall maintain a record that includes the reason no investigation
    was made and the name of the individual responsible for the decision not to
    investigate.
    (c) Any complaint involving the possible failure of a device, labeling, or
    packaging to meet any of its specifications shall be reviewed, evaluated, and
    investigated, unless such investigation has already been performed for a similar
    complaint and another investigation is not necessary.
    (d) Any complaint that represents an event which must be reported to FDA under
    part 803 of this chapter shall be promptly reviewed, evaluated, and investigated
    by a designated individual(s) and shall be maintained in a separate portion of
    the complaint files or otherwise clearly identified. In addition to the
    information required by § 820.198(e), records of investigation under this
    paragraph shall include a determination of:
    (1) Whether the device failed to meet specifications;
    (2) Whether the device was being used for treatment or diagnosis; and
    (3) The relationship, if any, of the device to the reported incident or adverse
    event.
    (e) When an investigation is made under this section, a record of the
    investigation shall be maintained by the formally designated unit identified in
    paragraph (a) of this section. The record of investigation shall include:
    (1) The name of the device;
    (2) The date the complaint was received;
    (3) Any unique device identifier (UDI) or universal product code (UPC), and any
    other device identification(s) and control number(s) used;
    (4) The name, address, and phone number of the complainant;
    (5) The nature and details of the complaint;
    (6) The dates and results of the investigation;
    (7) Any corrective action taken; and
    (8) Any reply to the complainant.
    (f) When the manufacturer's formally designated complaint unit is located at a
    site separate from the manufacturing establishment, the investigated
    complaint(s) and the record(s) of investigation shall be reasonably accessible
    to the manufacturing establishment.
    (g) If a manufacturer's formally designated complaint unit is located outside of
    the United States, records required by this section shall be reasonably
    accessible in the United States at either:
    (1) A location in the United States where the manufacturer's records are
    regularly kept; or
    (2) The location of the initial distributor.
    [61 FR 52654, Oct. 7, 1996, as amended at 69 FR 11313, Mar. 10, 2004; 71 FR
    16228, Mar. 31, 2006; 78 FR 58822, Sept. 24, 2013]

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    3. https://www.fda.gov/
    4. https://www.fda.gov/Medical-Devices
    5. https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
    assistance/medical-device-databases
    6. https://www.ecfr.gov
    7. /scripts/cdrh/cfdocs/search/default.cfm?FAQ=true
    8. https://www.fda.gov/medical-devices/medical-device-databases/code-federal-regulations-title-21-
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    9. /scripts/cdrh/devicesatfda/index.cfm?Search_Term=Complaint%20files%2E

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    3. https://www.fda.gov/
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