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means

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and distribution of a unit, lot, or batch of finished devices can be determined.

(e) Design history file (DHF) means a compilation of records which describes the design history of a finished device.

(f) Design input means the physical and performance requirements of a device that are used as a basis for device design.

(g) Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total finished design output consists of the device, its packaging and labeling, and the device master record. (h) Design review

documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.

(i) Device history record (DHR) means a compilation of records containing the production history of a finished device.

(j) Device master record (DMR) means a compilation of records containing the procedures and specifications for a finished device.

(k) Establish means define, document (in writing or electronically), and implement.

(1) Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

(m) Lot or batch means one or more components or finished devices that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

(n) Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer's quality policy and quality system.

(0) Manufacturer means any person who designs, manufactures, fabricates, assembles, or processes a finished device. Manufacturer includes but is not limited to those who perform the functions of contract sterilization, installa

tion, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.

(p) Manufacturing material means any material or substance used in or used to facilitate the manufacturing process, a concomitant constituent, or a byproduct constituent produced during the manufacturing process, which is present in or on the finished device as a residue or impurity not by design or intent of the manufacturer.

(q) Nonconformity means the nonfulfillment of a specified requirement.

(r) Product means components, manufacturing materials, in- process devices, finished devices, and returned devices.

(8) Quality means the totality of features and characteristics that bear on the ability of a device to satisfy fitness-for-use, including safety and performance.

(t) Quality audit means a systematic, independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.

(u) Quality policy means the overall intentions and direction of an organization with respect to quality, as established by management with executive responsibility.

(v) Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.

(w) Remanufacturer means any person who processes, conditions, renovates, repackages, restores, or does any other act to a finished device that significantly changes the finished device's performance or safety specifications, or intended use.

(x) Rework means action taken on a nonconforming product so that it will fulfill the specified DMR requirements before it is released for distribution.

(y) Specification means any requirement with which a product, process, service, or other activity must conform.

(2) Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.

(1) Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

(2) Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).

(aa) Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled. 8820.5 Quality system.

Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(8) designed or manufactured, and that meets the requirements of this part.

Subpart B-Quality System

Requirements $820.20 Management responsibility.

(a) Quality policy. Management with executive responsibility shall establish its policy and objectives for, and commitment to, quality. Management with executive responsibility shall ensure that the quality policy is understood, implemented, and maintained at all levels of the organization.

(b) Organization. Each manufacturer shall establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with the requirements of this part.

(1) Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.

(2) Resources. Each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance

of work, and assessment activities, including internal quality audits, to meet the requirements of this part.

(3) Management representative. Management with executive responsibility shall appoint, and document such appointment of, a member of management who, irrespective of other responsibilities, shall have established authority over and responsibility for:

(i) Ensuring that quality system requirements are effectively established and effectively maintained in accord,ance with this part; and

(ii) Reporting on the performance of the quality system to management with executive responsibility for review.

(c) Management review. Management with executive responsibility shall review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented.

(d) Quality planning. Each manufacturer shall establish a quality plan which defines the quality practices, resources, and activities relevant to devices that are designed and manufactured. The manufacturer shall establish how the requirements for quality will be met.

(e) Quality system procedures. Each manufacturer shall establish quality system procedures and instructions. An outline of the structure of the documentation used in the quality system shall be established where appropriate. 8820.22 Quality audit.

Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited. Corrective action(s), including reaudit of deficient matters, shall be taken when necessary. A report of the results of each quality audit, and reaudit(s) where taken, shall be made and such reports shall be reviewed by management having responsibility for the matters audited. The dates and results of quality audits and reaudits shall be documented.

$ 820.25 Personnel.

(a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.

(b) Training. Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.

(1) As part of their training, personnel shall be made aware of device defects which may occur from the improper performance of their specific jobs.

(2) Personnel who perform verification and validation activities shall be made aware of defects and errors that may be encountered as part of their job functions.

erence the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.

(c) Design input. Each manufacturer shall establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient. The procedures shall include a mechanism for addressing incomplete, ambiguous, or conflicting requirements. The design input requirements shall be documented and shall be reviewed and approved by a designated individual(s). The approval, including the date and signature of the individual(s) approving the requirements, shall be documented.

(d) Design output. Each manufacturer shall establish and maintain procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. Design output shall be documented, reviewed, and approved before release. The approval, including the date and signature of the individual(s) approving the output, shall be documented.

(e) Design review. Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall

Subpart C-Design Controls

$ 820.30 Design controls.

(a) General. (1) Each manufacturer of any class III or class II device, and the class I devices listed in paragraph (a)(2) of this section, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.

(2) The following class I devices are subject to design controls:

(i) Devices automated with computer software; and

(ii) The devices listed in the following chart.

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be documented in the design history file (the DHF).

(f) Design verification. Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.

(g) Design validation. Each manufacturer shall establish and maintain procedures for validating the device design. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents. Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions. Design validation shall include software validation and risk analysis, where appropriate. The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the DHF.

(h) Design transfer. Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly translated into production specifications.

(i) Design changes. Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.

(j) Design history file. Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part.

part. The procedures shall provide for the following:

(a) Document approval and distribution. Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented. Documents established to meet the requirements of this part shall be available at all locations for which they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed from all points of use or otherwise prevented from unintended use.

(b) Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.

Subpart E-Purchasing Controls $ 820.50 Purchasing controls.

Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.

(a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:

(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.

(2) Define the type and extent of control to be exercised over the product,

Subpart D-Document Controls

$ 820.40 Document controls.

Each manufacturer shall establish and maintain procedures to control all documents that are required by this

services, suppliers, contractors, and device conforms to its specifications. consultants, based on the evaluation Where deviations from device specificaresults.

tions could occur as a result of the (3) Establish and maintain records of manufacturing process, the manufacacceptable suppliers, contractors, and turer shall establish and maintain consultants.

process control procedures that de(b) Purchasing data. Each manufac- scribe any process controls necessary turer shall establish and maintain data to ensure conformance to specificathat clearly describe or reference the tions. Where process controls are needspecified requirements, including qual- ed they shall include: ity requirements, for purchased or oth- (1) Documented instructions, standerwise received product and services. ard operating procedures (SOP's), and Purchasing documents shall include, methods that define and control the where possible, an agreement that the manner of production; suppliers, contractors, and consultants (2) Monitoring and control of process agree to notify the manufacturer of parameters and component and device changes in the product or service so characteristics during production; that manufacturers may determine (3) Compliance with specified refwhether the changes may affect the erence standards or codes; quality of a finished device. Purchasing (4) The approval of processes and data shall be approved in accordance process equipment; and with 8 820.40.

(5) Criteria for workmanship which

shall be expressed in documented Subpart F-Identification and standards or by means of identified and Traceability

approved representative samples.

(b) Production and process changes. 8820.60 Identification.

Each manufacturer shall establish and Each manufacturer shall establish

maintain procedures for changes to a

specification, method, process, or proand maintain procedures for identi

cedure. Such changes shall be verified fying product during all stages of re

or where appropriate validated accordceipt, production, distribution, and installation to prevent mixups.

ing to $820.75, before implementation

and these activities shall be docu8820.65 Traceability.

mented. Changes shall be approved in

accordance with $ 820.40. Each manufacturer of a device that is

(c) Environmental control. Where enviintended for surgical implant into the

ronmental conditions could reasonably body or to support or sustain life and

be expected to have an adverse effect whose failure to perform when properly

on product quality, the manufacturer used in accordance with instructions

shall establish and maintain procefor use provided in the labeling can be

dures to adequately control these envireasonably expected to result in a sig

ronmental conditions. Environmental nificant injury to the user shall estab

control system(s) shall be periodically lish and maintain procedures for iden

inspected to verify that the system, intifying with a control number each

cluding necessary equipment, is adeunit, lot, or batch of finished devices

quate and functioning properly. These and where appropriate components.

activities shall be documented and reThe procedures shall facilitate correc

viewed. tive action. Such identification shall

(d) Personnel. Each manufacturer be documented in the DHR.

shall establish and maintain require

ments for the health, cleanliness, perSubpart G-Production and

sonal practices, and clothing of perProcess Controls

sonnel if contact between such per

sonnel and product or environment 8820.70 Production and process con- could reasonably be expected to have trols.

an adverse effect on product quality. (a) General. Each manufacturer shall The manufacturer shall ensure that develop, conduct, control, and monitor maintenance and other personnel who production processes to ensure that a are required to work temporarily under

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