QMSR Section 820.35 (Control of Records)

Adds record content the FDA requires beyond ISO 13485 clause 4.2.5: required content for complaint, servicing, and UDI records, and a way to mark confidential records to help the FDA decide on disclosure.

What each paragraph adds

820.35(a)

Complaint records. Keep records of the review, evaluation, and investigation of complaints about a possible failure to meet specifications. Three groups need seven recorded items: complaints reportable under Part 803, complaints the manufacturer determines must be investigated, and complaints it investigated anyway. The items: device name; date received; any UDI or UPC and other identification; the complainant's name, address, and phone number; nature of the complaint; any correction or corrective action; any reply to the complainant.

820.35(b)

Servicing records. At a minimum, record the device name, any UDI or UPC and other identification, the date of service, who serviced it, the service performed, and any test and inspection data.

820.35(c)

Unique device identification. Record the UDI for each device or batch of devices.

820.35(d)

Confidentiality. Records the manufacturer considers confidential may be marked to help the FDA decide whether they can be disclosed under Part 20.

Where it is written

21 CFR 820.35

Also called

21 CFR 820.35, 820.35

Related terms