In addition to the requirements of Clause 4.2.5 in ISO 13485 (incorporated by reference, see § 820.7), Control of Records, the manufacturer must include the following information in certain records:

(a) Records of complaints. In addition to Clause 8.2.2 in ISO 13485, Complaint Handling, the manufacturer shall maintain records of the review, evaluation, and investigation for any complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications. If an investigation has already been performed for a similar complaint, another investigation is not necessary, and the manufacturer shall maintain records documenting justification for not performing such investigation. For complaints that must be reported to FDA under part 803 of this chapter, complaints that a manufacturer determines must be investigated, and complaints that the manufacturer investigated regardless of those requirements, the manufacturer must record the following information:

(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);

(4) The name, address, and phone number of the complainant;

(5) The nature and details of the complaint;

(6) Any correction or corrective action taken; and

(7) Any reply to the complainant.

(b) Records of servicing activities. In adhering to Clause 7.5.4 in ISO 13485, Servicing Activities, the manufacturer must record the following information, at a minimum, for servicing activities:

(1) The name of the device serviced;

(2) Any UDI or UPC, and any other device identification(s);

(3) The date of service;

(4) The individual(s) who serviced the device;

(5) The service performed; and

(6) Any test and inspection data.

(c) Unique Device Identification. In addition to the requirements of Clauses 7.5.1, 7.5.8, and 7.5.9 in ISO 13485, the UDI must be recorded for each medical device or batch of medical devices.

(d) Confidentiality. Records deemed confidential by the manufacturer may be marked to aid FDA in determining whether information may be disclosed under the public information regulation in part 20 of this chapter.

In addition to the requirements of Clause 7.5.1 of ISO 13485 (incorporated by reference, see § 820.7), Control of production and service provision, each manufacturer must document and maintain procedures that provide a detailed description of the activities to ensure the integrity, inspection, storage, and operations for labeling and packaging, during the customary conditions of processing, storage, handling, distribution, and, as appropriate, use of the device.

(a) The manufacturer must ensure labeling and packaging has been examined for accuracy prior to release or storage where applicable, to include the following:

(1) The correct unique device identifier (UDI) or universal product code (UPC), or any other device identification(s);

(2) Expiration date;

(3) Storage instructions;

(4) Handling instructions; and

(5) Any additional processing instructions.

(b) The release of the labeling for use must be documented in accordance with Clause 4.2.5 of ISO 13485.

(c) The manufacturer must ensure labeling and packaging operations have been established and maintained to prevent mixups, including, but not limited to, inspection of the labeling and packaging before use to assure that all devices have correct labeling and packaging, as specified in the medical device file. Results of such labeling inspection must be documented in accordance with Clause 4.2.5 of ISO 13485.