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CFR - Code of Federal Regulations Title 21

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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28 views

CFR - Code of Federal Regulations Title 21

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.

Uploaded by

Atul Gaikwad
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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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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