Part 820 – QUALITY MANAGEMENT SYSTEM REGULATION (Draft) Table of Contents
Subpart A – General Provisions
820.1 Scope of Application.
820.3 Terminology
820.5 [Reserved]
820.7 Built-in by Reference
820.10 Quality Management System Requirements
820.15 Conceptual Clarification.
Subpart B – Supplementary provisions
820.20-820.30 [Reserved]
820.35 [Reserved]
820.40 [Reserved]
820.45 Control of equipment labeling and packaging
Subpart C-O- [Reserved].
Part 820 – QUALITY MANAGEMENT SYSTEM REGULATION (Draft) Text
Subpart A – General Provisions
§820.1 Scope of application
（a）applicability
The requirements of the current Good Manufacturing Practices (CGMP) are set forth in this Quality Management System Regulation (QMSR). The requirements of this Part cover methods, equipment and controls used in the following operations The requirements of this Part cover methods, equipment, and controls used in the design, manufacture, packaging, labeling, storage, installation, and ancillary services of all finished devices intended for use on the human body. The purpose of the requirements of this Part is to ensure that finished devices are safe and effective and otherwise comply with the Federal Food, Drug, and Cosmetic Act. Manufacturers engaged in the design, manufacture, packaging, labeling, storage, installation, or servicing of finished devices are required to establish and maintain a quality management system compatible with the specific device. Manufacturers covered by this Part include, but are not limited to, manufacturers performing contract sterilization, installation, relabeling, remanufacturing, repackaging, or specification development functions, and foreign initial distributors performing these functions. If a manufacturer engages in only some of the functions covered by the requirements of this Part and not others, the manufacturer need only comply with the requirements applicable to the functions in which it engages.
（1）Completed equipment
The provisions of this Part apply to finished devices intended for the human body as defined in this Part that are manufactured or imported, and offered for importation, in any state or protectorate of the United States, the District of Columbia, or the Commonwealth of Puerto Rico.
（2）Component or part
The provisions of this Part do not apply to manufacturers of components or parts of complete equipment, but such manufacturers are encouraged to review the provisions of this provision as necessary.
（3）Blood and blood components
The provisions of this Part do not apply to manufacturers of blood and blood components used for transfusion or production. Such manufacturers are subject to Subchapter F of this Chapter.
（4）HCT / Ps
The provisions of this Part apply to manufacturers of human cells, tissues, or cellular or tissue-based products (HCT/P) that are devices, as defined in § 1271.3(d) of this chapter (subject to premarket approval or notice, or excluded from notice under an application relying on the device provisions of federal law or under an application for a biological product license under Public Health Service Act § 351 (those exempted from notice) applies to manufacturers of human cells, tissues, or products based on cells or tissues (HCT/P). HCT/Ps regulated as devices are subject to the donor eligibility requirements in subpart C of this chapter, Part 1271, and the applicable current GTP (good tissue practice) requirements in subpart D of this chapter, Part 1271. In the event of any inconsistency between the regulations applicable in and other parts of this chapter, the regulations applicable specifically to the device in question shall take precedence over other generally applicable regulations.
（b）Conflicts with other requirements under the Federal Food, Drug, and Cosmetic Act
The QMSRs for equipment in this Part shall, unless otherwise specified, supersede any other generally applicable regulations in the event of a conflict between the regulations applicable in this Part and the other Parts of this Chapter that supplement the regulations in the other Parts of this Chapter, the regulations applicable specifically to the equipment in question shall supersede the other generally applicable regulations. In addition, ISO 13485 (incorporated by reference. See § 820.7), to the extent that the provisions of the Federal Food, Drug, and Cosmetic Act and/or other implementing regulations, the Federal Food, Drug, and Cosmetic Act and/or other implementing regulations, shall control.
（c）Foreign manufacturer
If the owner, operator, or agent of a factory, warehouse, or facility providing equipment for importation into the United States forbids, refuses, restricts, or refuses to permit entry into or inspection of a foreign facility by any method of inspection or use for the purpose of determining compliance with this Part, or the manufacture, packaging, storage, installation If the equipment and controls used to maintain the plant, warehouse, or facility provided for the manufacture, packaging, storage, installation, processing, or importation into the United States do not comply with the requirements of section 520(f) of the Federal Food, Drug, and Cosmetic Act and this Part, equipment manufactured at that facility shall be subject to section 501(h) or (j) of the Federal Food, Drug, and Cosmetic Act ) or (j) of the Federal Food, Drug, and Cosmetic Act, and denied entry into the United States under section 801(a) of the Federal Food, Drug, and Cosmetic Act.
（d）Exemptions and variations
（1）A manufacturer subject to requirements under section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act may apply for a waiver and variation of such requirements pursuant to section 520(f)(2) of the Federal Food, Drug, and Cosmetic Act, including requirements under this Part 520(f)(2) of the Federal Food, Drug, and Cosmetic Act. Applications for waivers or variations shall be submitted in accordance with the procedures described in § 10.30 of this chapter.
（2）The FDA may initiate and grant a deviation from the requirements of this Part if it determines that such deviation is in the best interest of public health. Such a deviation is valid only if the public health need for the device persists and the device would not be readily available without the deviation.
§820.3 Definitions of terms
The definitions in ISO 13485 (incorporated by reference. See § 820.7) applies to this PART and does not affect the meaning of similar terms defined in this title, except as specified in paragraph (b) of this section.
（a）The following terms are necessary for the purposes of this Part and do not appear in ISO 13485.
Components
A raw material, substance, part, component, software, firmware, labeling or assembly that is intended to be included as part of a finished, packaged and labeled device.
client
A person or organization, including the user, who is entitled to the intended or requested product or service. A customer can be internal or external to the organization.
Design validation
It refers to establishing by objective evidence that equipment specifications are compatible with user needs and intended use.
Federal Food, Drug and Cosmetic Act
See Federal Food, Drug, and Cosmetic Act, as amended, 21 U.S.C. 321.
Completed equipment
A device or accessory of a device that is fit for use and capable of functioning. It may or may not be packaged, labeled, or sterilized.
A human cell, tissue, or cell or tissue-based product (HCT/P) that is regulated as a medical devicemeans an HCT / P as defined in § 1271.3(d) of this chapter that does not meet the criteria of § 1271.10(a) of this chapter and is also regulated as a device Means an HCT / P as defined in § 1271.3(d) of this chapter.
incompatible
Failure to meet regulatory requirements.
process agent
Means a material or substance used in or to facilitate a manufacturing process, an incidental component, or a component of a byproduct produced during the manufacturing process, which is not of the manufacturer’s design or intent and is present in or on the finished equipment as a residue or impurity.
Process Validation
The establishment by objective evidence that a process consistently produces a result or product that meets predetermined specifications.
Reclamation
A person who processes, adjusts, renovates, repackages, repairs, or otherwise materially alters the performance or safety specifications or intended use of the Finished Equipment.
rework
Actions taken to meet specified requirements for nonconforming products before they are released for distribution.
senior management
A senior employee of a manufacturer who has the authority to establish or modify the manufacturer’s quality policy and quality management system.
verification
It refers to confirming that regulatory requirements are being met by examining and submitting objective evidence.
（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 relevant terms and definitions in ISO 13485 (e.g., device and label definitions in Section 201). (h) and (m) of the Federal Food, Drug, and Cosmetic Act apply to this PART and supersede the definitions of relevant terms in ISO 13485 (labeling and medical devices). In addition, the following terms and definitions supersede the correlative terms and definitions in ISO 13485.
manufacturer
A person who designs, manufactures, fabricates, assembles, or processes finished equipment. Manufacturers include, but are not limited to. A manufacturer includes, but is not limited to, those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repackaging, or specification, as well as primary distributors of foreign organizations that perform these functions.
Product
Refers to components, process agents, in-process equipment, finished equipment, and returned equipment.
§820.5
[Reserved]§820.7
Built-in by Reference
Certain materials are incorporated by reference in this part with the approval of the Director of the Federal Register pursuant to 5 U.S.C. 552(a) and 1 CFR Part 51. All approved materials are available from the Food and Drug Administration, Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, and the National Archives and Records Administration ( For availability of this material at NARA, call 202-741-6030, send to あるいは電子メールでfr.inspection@nara.gov, or or by visiting
www.archives.gov/ federal-register / cfr /ibr-locations.html
Available from the following sources
（a）International Organization for Standardization (ISO)
BIBC II、Chemin de Blandonnet 8、CP 401、1214 Vernier、Geneva, Switzerland; + 41-22-749-01-11; customerservice @ iso.org、https：//www.iso.org/store.html
（1）ISO 13485, “Medical devices – Quality management systems – Requirements for regulatory purposes,” 3rd ed. dated March 2016; IBR approved §§ 820.1; 820.3; 820.10; 820.15; 820.35; 820.45.
（2）[Reserved]
（b）[Reserved]
§820.10 Quality management system requirements.
As stated in §820.1(a), manufacturers subject to this PART are required to
（a）documentation
ISO 13485 (incorporated by reference. See § 820.7) and document a quality management system that complies with the requirements of this part.
（b）Applicable regulatory requirements
Comply with other applicable regulatory requirements of this title as required. Including but not limited to the following ISO 13485 clauses
（1）ISO 13485, Clause 7.5.8 For identification, manufacturers need to document a system for assigning unique device identifiers to medical devices in accordance with the requirements of Part 830.
（2）ISO 13485, Section 7.5.9.1, Traceability – In general, manufacturers should document traceability procedures in accordance with the requirements of Part 821, if applicable.
（3）For ISO 13485 Clause 8.2.3, Reporting to Regulatory Authorities, manufacturers are required to notify the FDA of complaints that meet the reporting criteria in Part 803 of this chapter.
（4）For Sections 7.2.3, 8.2.3, and 8.3.3, notices shall be processed in accordance with the requirements of Part 806.
（c） Design and Development
Manufacturers of Class II, Class III, and Class I equipment listed below must comply with the requirements of Design and Development, Clause 7.3, and its sub-clauses of ISO 13485. Class I equipment is as follows
（1）Equipment automated by computer software
（2）Equipment listed below:
Paragraph (c)(2) from Table 1
| section | machinery and tools |
| 868.6810 | Catheter, tracheobronchial suction. |
| 878.4460 | Handbags, surgical medical. |
| 880.6760 | For fixing apparatus and protection. |
| 892.5650 | System, applicator, radionuclide, led. |
| 892.5740 | Radiation sources, radionuclides, and telemedicine. |
（d）life-support system
Manufacturers of life support devices may reasonably expect that failure to function when used properly in accordance with the instructions for use on the label will result in serious injury, and therefore, as necessary, in addition to all other requirements of this part, the ISO 13485, Section 7.5.9.2, Implantable Devices Traceability requirements for implantable devices in ISO 13485, in addition to all other requirements of this part, should be complied with, if necessary.
（e）execution
Failure to comply with the applicable requirements of this PART will render the equipment adulterated under Section 501(h) of the Federal Food, Drug, and Cosmetic Act. Both such equipment and the responsible party for failure to comply will be subject to regulatory action.
§820.15 Conceptual Clarification
Manufacturers covered by this Part are required to interpret the following terms in ISO 13485 (incorporated by reference. See § 820.7) should interpret the following terms in ISO 13485 (incorporated by reference) as follows
（a）organization
Manufacturer” as defined in this Part shall have the meaning given to it.
（b）Safety and Performance
For the purposes of this Part, “safety and effectiveness” shall have the meaning given to it. The phrase “safety and performance” shall not relieve the manufacturer from the obligation to implement controls or other measures that provide reasonable assurance of safety and effectiveness.
（c）Process Validation
shall have the meaning of “process validation” as defined in this Part.
Subpart B – Supplementary provisions
§820.20-§820.30
[Pending]§ 820.35 Maintenance of records.
In addition to the requirements of Clause 4.2.5 Management of Records in ISO 13485 (incorporated by reference, see § 820.7), the manufacturer must obtain the signature of each individual who has approved or re-approved a record, and the date of that approval, and include in that record the following information for the specific record as follows
（a）Record of Complaints
In addition to the ISO 13485 complaint handling provision 8.2.2, manufacturers shall, for complaints that must be reported to the FDA under Part 803 of this chapter, for complaints that the manufacturer determines need to be investigated, and for complaints that the manufacturer investigates, regardless of those requirements, at least the following The following information must be recorded. :
（1）Equipment Name
（2）Date complaint received
（3）Unique Device Identifier (UDI) or Universal Product Code (UPC) and other device IDs
（4）Name, address, and telephone number of the complainant
（5）Nature and details of the complaint
（6）Corrective actions taken
（7）Response to the petitioner
（b）Records of ancillary service activities
When complying with ISO 13485 Clause 7.5.4, Ancillary services activities, the manufacturer shall record at least the following information for ancillary services activities
（1）Name of equipment to be serviced
（2）Unique Device Identifier (UDI) or Universal Product Code (UPC), and other device IDs
（3）Date of Service
（4）Individuals who have had equipment repaired
（5）Services performed
（6）Test and Inspection Data
（c）Unique device identifier
In addition to the requirements of ISO 13485 clauses 7.5.1, 7.5.8, and 7.5.9, the UDI must record for each medical device or batch of medical devices.
（d）duty of confidentiality
Records deemed confidential by the manufacturer may be marked to assist the FDA in determining whether the information may be disclosed under the public information regulations in Part 20 of this chapter.
§820.40
[Reserved]§820.45 Control of equipment labeling and packaging
In addition to the requirements of ISO 13485 (incorporated by reference, see § 820.7) Clause 7.5.1 Management of manufacture and service provision, each manufacturer shall establish and maintain procedures that provide a detailed description of activities to assure the integrity, inspection, storage, and operation for labeling and packaging, processing, storage, handling, distribution under normal conditions, and, where applicable In addition to the requirements for control of manufacturing and servicing, each manufacturer should establish and maintain procedures that provide a detailed description of activities to ensure the integrity, inspection, storage, and operation for labeling and packaging, handling, storage, handling, distribution, and use of equipment, if applicable.
（a）Prior to release or storage, the manufacturer must ensure that labeling and packaging is inspected for accuracy, including, if applicable
（1）Correct Unique Device Identifier (UDI) or Universal Product Code (UPC) or other device ID
（2）effective date
（3）custody instruction
（4）handling instructions
（5）Additional processing steps
（b）The release of labeling for use should be documented according to ISO 13485, section 4.2.5.
（c）Manufacturers need to ensure that labeling and packaging practices are established and maintained to prevent errors. This includes, but is not limited to, inspections of labeling and packaging immediately prior to use to ensure that all devices are properly labeled and packaged as specified in the medical device file. The results of such labeling inspections should be documented in accordance with ISO 13485, Section 4.2.5.
Subpart C-O- [Reserved].
Date of promulgation of the proposal: February 8, 2022.
related product
[blogcard url=”https://ecompliance.co.jp/SHOP/O094.html” title=”【VOD】QMSRセミナー (Quality Management System Regulation)”content=”2022年2月23日、FDAは現行のQSR（品質システム規制：21CFR Part 820 Quality System Regulations）をISO 13485:2016に整合させる改正案を公表しました。
QSRは1996年10月7日に現行の規則が発効されて以降、20年以上に渡り米国における医療機器品質システム規制として機能してきたものです。
これまでの間、QSRは軽微な修正はあったものの、改定は一度も実施されてきませんでした。
FDAがQSRによる規制を実施する一方で、品質システム規制に対する当局の期待は時代とともに変化し続けてきました。
日本や欧州、カナダといった多くの国の規制当局は、医療機器の品質システムに関するマネジメント規格であるISO 13485を品質システム規制として取り入れています。
FDAも、他国の規制当局との調和の利点を認識しており、MDSAPへの参加等、規制のハーモナイゼーション活動に取り組んできました。
そして今般、医療機器品質システム規制の国際整合を目指し、QSRのISO13485:2016への調和を目指すこととなりました。
QSRをISO 13485:2016と整合させる規制は「Quality Management System Regulations / QMSR」（品質マネジメントシステム規制）と呼ばれます。
QMSRはISO 13485:2016の要求事項を組み込むことにより、ISO 13485:2016と多くの要求を整合さる予定です。
その一方で、苦情ファイル等の記録の保持に関してISO 13485:2016に追加的要求事項を上乗せしています。
本セミナーでは、QMSRにおける改正点のみではなく、QMSR全般について詳しくわかりやすく解説します。
また、QMSRの要求事項およびISO 13485:2016との差異、QMSRの要求事項を満たすQMS構築について解説します。”]
QSRは1996年10月7日に現行の規則が発効されて以降、20年以上に渡り米国における医療機器品質システム規制として機能してきたものです。
これまでの間、QSRは軽微な修正はあったものの、改定は一度も実施されてきませんでした。
FDAがQSRによる規制を実施する一方で、品質システム規制に対する当局の期待は時代とともに変化し続けてきました。
日本や欧州、カナダといった多くの国の規制当局は、医療機器の品質システムに関するマネジメント規格であるISO 13485を品質システム規制として取り入れています。
FDAも、他国の規制当局との調和の利点を認識しており、MDSAPへの参加等、規制のハーモナイゼーション活動に取り組んできました。
そして今般、医療機器品質システム規制の国際整合を目指し、QSRのISO13485:2016への調和を目指すこととなりました。
QSRをISO 13485:2016と整合させる規制は「Quality Management System Regulations / QMSR」（品質マネジメントシステム規制）と呼ばれます。
QMSRはISO 13485:2016の要求事項を組み込むことにより、ISO 13485:2016と多くの要求を整合さる予定です。
その一方で、苦情ファイル等の記録の保持に関してISO 13485:2016に追加的要求事項を上乗せしています。
本セミナーでは、QMSRにおける改正点のみではなく、QMSR全般について詳しくわかりやすく解説します。
また、QMSRの要求事項およびISO 13485:2016との差異、QMSRの要求事項を満たすQMS構築について解説します。”]
content=”ISO-13485:2016に沿った形の品質マニュアル（ひな形）です。
多くの医療機器企業では、ISO-9001やISO-13485に沿った品質マニュアルを作成していますが、ISO-13485認証審査対応のためには、QSR（品質システム規則：21 CFR 820）に従った品質マニュアルを作成し、説明しなければなりません。
これから作成する医療機器企業様およびISO-13485認証審査を予定している企業様、認証機関から改善指示を受けた企業様向けに、サンプルをご用意いたしました。
MS-Word形式ですので、貴社でご自由に加筆・修正を行っていただけます。”]
]]>
Comment