21 CFR 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
(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;
(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.
(1) A location in the United States where the manufacturer's records are regularly kept; or
(2) The location of the initial distributor.
Title 21 published on 2015-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 820 after this date.
- 21 CFR 864.3250 — Specimen Transport and Storage Container.
- 21 CFR 874.3540 — Prosthesis Modification Instrument for Ossicular Replacement Surgery.
- 21 CFR 886.4750 — Ophthalmic Eye Shield.
- 21 CFR 886.1780 — Retinoscope.
- 21 CFR 864.3260 — OTC Test Sample Collection Systems for Drugs of Abuse Testing.
- 21 CFR 880.5270 — Neonatal Eye Pad.
- 21 CFR 882.1500 — Esthesiometer.
- 21 CFR 878.3910 — Noninflatable Extremity Splint.
- 21 CFR 874.1500 — Gustometer.
- 21 CFR 872.6300 — Rubber Dam and Accessories.
- 21 CFR 886.1350 — Keratoscope.
- 21 CFR 882.1200 — Two-Point Discriminator.
- 21 CFR 880.2930 — Apgar Timer.
- 21 CFR 876.5210 — Enema Kit.
- 21 CFR 862.2270 — Thin-Layer Chromatography System for Clinical Use.