PART 820—QUALITY MANAGEMENT SYSTEM REGULATION Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264. Source: 89 FR 7523, Feb. 2, 2024, unless otherwise noted. Subpart A—General Provisions § 820.1 Scope. (a) Applicability. (1) Finished devices. (2) Components or parts. (3) Blood and blood components. (4) HCT/Ps. (b) Conflicts with other requirements under the Federal Food, Drug, and Cosmetic Act. (c) Foreign manufacturers. (d) Exemptions or variances. (2) FDA may initiate and grant a variance from any requirement(s) in this part when the Agency determines that such variance is in the best interest of the public health, including that there is a public health need for the device and the device would not likely be made sufficiently available without the variance. Such variance will remain in effect only so long as there remains a public health need for the device and the device would not likely be made sufficiently available without the variance. § 820.3 Definitions. The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see § 820.7) apply to this part, except as specified in paragraph (b) of this section, and do not affect the meaning of similar terms defined in this title. (a) The following terms, which are either not used or not defined in ISO 13485 or in Clause 3 of ISO 9000, also apply for the purposes of this part: Batch lot Component Federal Food, Drug, and Cosmetic Act et seq., Finished device Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device Remanufacturer (b) All definitions in section 201 of the Federal Food, Drug, and Cosmetic Act shall apply to the regulation of quality management systems under this part and shall supersede the correlating terms and definitions in ISO 13485 ( e.g., Implantable medical device Manufacturer Organization Rework Safety and Performance [89 FR 7523, Feb. 2, 2024; 89 FR 82945, Oct. 15, 2024] § 820.5 [Reserved] § 820.7 Incorporation by reference. Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Food and Drug Administration, and at the National Archives and Records Administration (NARA). Contact FDA at: Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852; 240-402-7500; https://www.regulations.gov/document/FDA-2013-S-0610-0003. www.archives.gov/federal-register/cfr/ibr-locations [email protected]. [email protected], https://www.iso.org/store.html. (a) ISO 9000:2015(E) (“ISO 9000”), Quality Management systems—Fundamentals and vocabulary, Terms and definitions, (b) ISO 13485:2016(E) (“ISO 13485”), Medical devices—Quality management systems—Requirements for regulatory purposes, § 820.10 Requirements for a quality management system. A manufacturer subject to this part as described by § 820.1(a) must: (a) Document. (b) Applicable regulatory requirements. (1) For Clause 7.5.8 in ISO 13485, Identification, the manufacturer must document a system to assign unique device identification to the medical device in accordance with the requirements of part 830 of this chapter. (2) For Clause 7.5.9.1 in ISO 13485, Traceability—General, the manufacturer must document procedures for traceability in accordance with the requirements of part 821 of this chapter, if applicable. (3) For Clause 8.2.3 in ISO 13485, Reporting to regulatory authorities, the manufacturer must notify FDA of complaints that meet the reporting criteria of part 803 of this chapter. (4) For Clauses 7.2.3, 8.2.3, and 8.3.3, advisory notices shall be handled in accordance with the requirements of part 806 of this chapter. (c) Design and development. (1) Devices automated with computer software; and (2) The devices listed in the following table: Table 1 to Paragraph ( c Section Device 868.6810 Catheter, Tracheobronchial Suction. 878.4460 Glove, Non-powdered Surgeon's. 880.6760 Restraint, Protective. 892.5650 System, Applicator, Radionuclide, Manual. 892.5740 Source, Radionuclide Teletherapy. (d) Devices that support or sustain life. (e) Enforcement. Subpart B—Supplemental Provisions §§ 820.20-820.30 [Reserved] § 820.35 Control of records. 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. (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. (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. (d) Confidentiality. § 820.40 [Reserved] § 820.45 Device labeling and packaging controls. 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. Subparts C-O [Reserved]