eCFR Reference Browser

---

title: "21 CFR §820.200"

source: "https://www.ecfr.gov/current/title-21/section-820.200"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "820"

part_subject: "QUALITY SYSTEM REGULATION"

subpart_code: "N"

subpart_subject: "Servicing"

section_number: "820.200"

section_subject: "Servicing."

cfr_reference: "21 CFR 820.200"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)Where servicing is a specified requirement, each manufacturer shall establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements.

(b)Each manufacturer shall analyze service reports with appropriate statistical methodology in accordance with § 820.100.

(c)Each manufacturer who receives a service report that represents an event which must be reported to FDA under part 803 of this chapter shall automatically consider the report a complaint and shall process it in accordance with the requirements of § 820.198.

(d)Service reports shall be documented and shall include:

(1)The name of the device serviced;

(2)Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used;

(3)The date of service;

(4)The individual(s) servicing the device;

(5)The service performed; and

(6)The test and inspection data.

§820.200 - Servicing.