[Code of Federal Regulations]
[Title 21, Volume 8, Parts 800 to 1299]
[Revised as of April 1, 1998]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR820]
[Page 143-156]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued)
PART 820--QUALITY SYSTEM REGULATION
Subpart A--General Provisions
Sec.
820.1 Scope.
820.3 Definitions.
820.5 Quality system.
Subpart B--Quality System Requirements
820.20 Management responsibility.
820.22 Quality audit.
820.25 Personnel.
Subpart C--Design Controls
820.30 Design controls.
Subpart D--Document Controls
820.40 Document controls.
Subpart E--Purchasing Controls
820.50 Purchasing controls.
Subpart F--Identification and Traceability
820.60 Identification.
820.65 Traceability.
Subpart G--Production and Process Controls
820.70 Production and process controls.
820.72 Inspection, measuring, and test equipment.
820.75 Process validation.
Subpart H--Acceptance Activities
820.80 Receiving, in-process, and finished device acceptance.
820.86 Acceptance status.
Subpart I--Nonconforming Product
820.90 Nonconforming product.
Subpart J--Corrective and Preventive Action
820.100 Corrective and preventive action.
Subpart K--Labeling and Packaging Control
820.120 Device labeling.
820.130 Device packaging.
Subpart L--Handling, Storage, Distribution, and Installation
820.140 Handling.
820.150 Storage.
820.160 Distribution.
820.170 Installation.
Subpart M--Records
820.180 General requirements.
820.181 Device master record.
820.184 Device history record.
820.186 Quality system record.
820.198 Complaint files.
Subpart N--Servicing
820.200 Servicing.
Subpart O--Statistical Techniques
820.250 Statistical techniques.
Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i,
360j, 360l, 371, 374, 381, 383.
Source: 61 FR 52654, Oct. 7, 1996, unless otherwise noted.
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Subpart A--General Provisions
Sec. 820.1 Scope.
(a) Applicability. (1) Current good manufacturing practice (CGMP)
requirements are set forth in this quality system regulation. The
requirements in this part govern the methods used in, and the facilities
and controls used for, the design, manufacture, packaging, labeling,
storage, installation, and servicing of all finished devices intended
for human use. The requirements in this part are intended to ensure that
finished devices will be safe and effective and otherwise in compliance
with the Federal Food, Drug, and Cosmetic Act (the act). This part
establishes basic requirements applicable to manufacturers of finished
medical devices. If a manufacturer engages in only some operations
subject to the requirements in this part, and not in others, that
manufacturer need only comply with those requirements applicable to the
operations in which it is engaged. With respect to class I devices,
design controls apply only to those devices listed in Sec. 820.30(a)(2).
This regulation does not apply to manufacturers of components or parts
of finished devices, but such manufacturers are encouraged to use
appropriate provisions of this regulation as guidance. Manufacturers of
human blood and blood components are not subject to this part, but are
subject to part 606 of this chapter.
(2) The provisions of this part shall be applicable to any finished
device as defined in this part, intended for human use, that is
manufactured, imported, or offered for import in any State or Territory
of the United States, the District of Columbia, or the Commonwealth of
Puerto Rico.
(3) In this regulation the term ``where appropriate'' is used
several times. When a requirement is qualified by ``where appropriate,''
it is deemed to be ``appropriate'' unless the manufacturer can document
justification otherwise. A requirement is ``appropriate'' if
nonimplementation could reasonably be expected to result in the product
not meeting its specified requirements or the manufacturer not being
able to carry out any necessary corrective action.
(b) Limitations. The quality system regulation in this part
supplements regulations in other parts of this chapter except where
explicitly stated otherwise. In the event that it is impossible to
comply with all applicable regulations, both in this part and in other
parts of this chapter, the regulations specifically applicable to the
device in question shall supersede any other generally applicable
requirements.
(c) Authority. Part 820 is established and issued under authority of
sections 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704,
801, 803 of the act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h,
360i, 360j, 360l, 371, 374, 381, 383). The failure to comply with any
applicable provision in this part renders a device adulterated under
section 501(h) of the act. Such a device, as well as any person
responsible for the failure to comply, is subject to regulatory action.
(d) Foreign manufacturers. If a manufacturer who offers devices for
import into the United States refuses to permit or allow the completion
of a Food and Drug Administration (FDA) inspection of the foreign
facility for the purpose of determining compliance with this part, it
shall appear for purposes of section 801(a) of the act, that the methods
used in, and the facilities and controls used for, the design,
manufacture, packaging, labeling, storage, installation, or servicing of
any devices produced at such facility that are offered for import into
the United States do not conform to the requirements of section 520(f)
of the act and this part and that the devices manufactured at that
facility are adulterated under section 501(h) of the act.
(e) Exemptions or variances. (1) Any person who wishes to petition
for an exemption or variance from any device quality system requirement
is subject to the requirements of section 520(f)(2) of the act.
Petitions for an exemption or variance shall be submitted according to
the procedures set forth in Sec. 10.30 of this chapter, the FDA's
administrative procedures. Guidance is available from the Center for
Devices and Radiological Health, Division of Small Manufacturers
Assistance, (HFZ-220), 1350 Piccard Dr., Rockville, MD 20850, U.S.A.,
telephone 1-800-638-2041 or 1-301-443-6597, FAX 301-443-8818.
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(2) FDA may initiate and grant a variance from any device quality
system requirement when the agency determines that such variance is in
the best interest of the public health. 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.
(f) This part does not apply to distributors of cigarettes or
smokeless tobacco as defined in part 897 of this chapter.
Sec. 820.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act, as amended
(secs. 201-903, 52 Stat. 1040 et seq., as amended (21 U.S.C. 321-394)).
All definitions in section 201 of the act shall apply to the regulations
in this part.
(b) Complaint means any written, electronic, or oral communication
that alleges deficiencies related to the identity, quality, durability,
reliability, safety, effectiveness, or performance of a device after it
is released for distribution.
(c) Component means any raw material, substance, piece, part,
software, firmware, labeling, or assembly which is intended to be
included as part of the finished, packaged, and labeled device.
(d) Control number means any distinctive symbols, such as a
distinctive combination of letters or numbers, or both, from which the
history of the manufacturing, packaging, labeling, 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 means a 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.
(l) 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.
(o) 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, installation, 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.
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(s) 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.
(z) 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.
Sec. 820.5 Quality system.
Each manufacturer shall establish and maintain a quality system that
is appropriate for the specific medical device(s) designed or
manufactured, and that meets the requirements of this part.
Subpart B--Quality System Requirements
Sec. 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 accordance with this part; and
(ii) Reporting on the performance of the quality system to
management with executive responsibility for review.
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(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.
Sec. 820.22 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 a 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.
Sec. 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.
Subpart C--Design Controls
Sec. 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.
------------------------------------------------------------------------
Section Device
------------------------------------------------------------------------
868.6810.......................... Catheter, Tracheobronchial Suction.
878.4460.......................... Glove, Surgeon's.
880.6760.......................... Restraint, Protective.
892.5650.......................... System, Applicator, Radionuclide,
Manual.
892.5740.......................... Source, Radionuclide Teletherapy.
------------------------------------------------------------------------
(b) Design and development planning. Each manufacturer shall
establish and maintain plans that describe or reference 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
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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 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.
Subpart D--Document Controls
Sec. 820.40 Document controls.
Each manufacturer shall establish and maintain procedures to control
all documents that are required by this 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
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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
Sec. 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, services, suppliers, contractors, and consultants, based on the
evaluation results.
(3) Establish and maintain records of acceptable suppliers,
contractors, and consultants.
(b) Purchasing data. Each manufacturer shall establish and maintain
data that clearly describe or reference the specified requirements,
including quality requirements, for purchased or otherwise received
product and services. Purchasing documents shall include, where
possible, an agreement that the suppliers, contractors, and consultants
agree to notify the manufacturer of changes in the product or service so
that manufacturers may determine whether the changes may affect the
quality of a finished device. Purchasing data shall be approved in
accordance with Sec. 820.40.
Subpart F--Identification and Traceability
Sec. 820.60 Identification.
Each manufacturer shall establish and maintain procedures for
identifying product during all stages of receipt, production,
distribution, and installation to prevent mixups.
Sec. 820.65 Traceability.
Each manufacturer of a device that is intended for surgical implant
into the body or to support or sustain life and whose failure to perform
when properly used in accordance with instructions for use provided in
the labeling can be reasonably expected to result in a significant
injury to the user shall establish and maintain procedures for
identifying with a control number each unit, lot, or batch of finished
devices and where appropriate components. The procedures shall
facilitate corrective action. Such identification shall be documented in
the DHR.
Subpart G--Production and Process Controls
Sec. 820.70 Production and process controls.
(a) General. Each manufacturer shall develop, conduct, control, and
monitor production processes to ensure that a device conforms to its
specifications. Where deviations from device specifications could occur
as a result of the manufacturing process, the manufacturer shall
establish and maintain process control procedures that describe any
process controls necessary to ensure conformance to specifications.
Where process controls are needed they shall include:
(1) Documented instructions, standard operating procedures (SOP's),
and methods that define and control the manner of production;
(2) Monitoring and control of process parameters and component and
device characteristics during production;
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(3) Compliance with specified reference standards or codes;
(4) The approval of processes and process equipment; and
(5) Criteria for workmanship which shall be expressed in documented
standards or by means of identified and approved representative samples.
(b) Production and process changes. Each manufacturer shall
establish and maintain procedures for changes to a specification,
method, process, or procedure. Such changes shall be verified or where
appropriate validated according to Sec. 820.75, before implementation
and these activities shall be documented. Changes shall be approved in
accordance with Sec. 820.40.
(c) Environmental control. Where environmental conditions could
reasonably be expected to have an adverse effect on product quality, the
manufacturer shall establish and maintain procedures to adequately
control these environmental conditions. Environmental control system(s)
shall be periodically inspected to verify that the system, including
necessary equipment, is adequate and functioning properly. These
activities shall be documented and reviewed.
(d) Personnel. Each manufacturer shall establish and maintain
requirements for the health, cleanliness, personal practices, and
clothing of personnel if contact between such personnel and product or
environment could reasonably be expected to have an adverse effect on
product quality. The manufacturer shall ensure that maintenance and
other personnel who are required to work temporarily under special
environmental conditions are appropriately trained or supervised by a
trained individual.
(e) Contamination control. Each manufacturer shall establish and
maintain procedures to prevent contamination of equipment or product by
substances that could reasonably be expected to have an adverse effect
on product quality.
(f) Buildings. Buildings shall be of suitable design and contain
sufficient space to perform necessary operations, prevent mixups, and
assure orderly handling.
(g) Equipment. Each manufacturer shall ensure that all equipment
used in the manufacturing process meets specified requirements and is
appropriately designed, constructed, placed, and installed to facilitate
maintenance, adjustment, cleaning, and use.
(1) Maintenance schedule. Each manufacturer shall establish and
maintain schedules for the adjustment, cleaning, and other maintenance
of equipment to ensure that manufacturing specifications are met.
Maintenance activities, including the date and individual(s) performing
the maintenance activities, shall be documented.
(2) Inspection. Each manufacturer shall conduct periodic inspections
in accordance with established procedures to ensure adherence to
applicable equipment maintenance schedules. The inspections, including
the date and individual(s) conducting the inspections, shall be
documented.
(3) Adjustment. Each manufacturer shall ensure that any inherent
limitations or allowable tolerances are visibly posted on or near
equipment requiring periodic adjustments or are readily available to
personnel performing these adjustments.
(h) Manufacturing material. Where a manufacturing material could
reasonably be expected to have an adverse effect on product quality, the
manufacturer shall establish and maintain procedures for the use and
removal of such manufacturing material to ensure that it is removed or
limited to an amount that does not adversely affect the device's
quality. The removal or reduction of such manufacturing material shall
be documented.
(i) Automated processes. When computers or automated data processing
systems are used as part of production or the quality system, the
manufacturer shall validate computer software for its intended use
according to an established protocol. All software changes shall be
validated before approval and issuance. These validation activities and
results shall be documented.
Sec. 820.72 Inspection, measuring, and test equipment.
(a) Control of inspection, measuring, and test equipment. Each
manufacturer shall ensure that all inspection, measuring, and test
equipment, including mechanical, automated, or electronic
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inspection and test equipment, is suitable for its intended purposes and
is capable of producing valid results. Each manufacturer shall establish
and maintain procedures to ensure that equipment is routinely
calibrated, inspected, checked, and maintained. The procedures shall
include provisions for handling, preservation, and storage of equipment,
so that its accuracy and fitness for use are maintained. These
activities shall be documented.
(b) Calibration. Calibration procedures shall include specific
directions and limits for accuracy and precision. When accuracy and
precision limits are not met, there shall be provisions for remedial
action to reestablish the limits and to evaluate whether there was any
adverse effect on the device's quality. These activities shall be
documented.
(1) Calibration standards. Calibration standards used for
inspection, measuring, and test equipment shall be traceable to national
or international standards. If national or international standards are
not practical or available, the manufacturer shall use an independent
reproducible standard. If no applicable standard exists, the
manufacturer shall establish and maintain an in-house standard.
(2) Calibration records. The equipment identification, calibration
dates, the individual performing each calibration, and the next
calibration date shall be documented. These records shall be displayed
on or near each piece of equipment or shall be readily available to the
personnel using such equipment and to the individuals responsible for
calibrating the equipment.
Sec. 820.75 Process validation.
(a) Where the results of a process cannot be fully verified by
subsequent inspection and test, the process shall be validated with a
high degree of assurance and approved according to established
procedures. The validation activities and results, including the date
and signature of the individual(s) approving the validation and where
appropriate the major equipment validated, shall be documented.
(b) Each manufacturer shall establish and maintain procedures for
monitoring and control of process parameters for validated processes to
ensure that the specified requirements continue to be met.
(1) Each manufacturer shall ensure that validated processes are
performed by qualified individual(s).
(2) For validated processes, the monitoring and control methods and
data, the date performed, and, where appropriate, the individual(s)
performing the process or the major equipment used shall be documented.
(c) When changes or process deviations occur, the manufacturer shall
review and evaluate the process and perform revalidation where
appropriate. These activities shall be documented.
Subpart H--Acceptance Activities
Sec. 820.80 Receiving, in-process, and finished device acceptance.
(a) General. Each manufacturer shall establish and maintain
procedures for acceptance activities. Acceptance activities include
inspections, tests, or other verification activities.
(b) Receiving acceptance activities. Each manufacturer shall
establish and maintain procedures for acceptance of incoming product.
Incoming product shall be inspected, tested, or otherwise verified as
conforming to specified requirements. Acceptance or rejection shall be
documented.
(c) In-process acceptance activities. Each manufacturer shall
establish and maintain acceptance procedures, where appropriate, to
ensure that specified requirements for in-process product are met. Such
procedures shall ensure that in-process product is controlled until the
required inspection and tests or other verification activities have been
completed, or necessary approvals are received, and are documented.
(d) Final acceptance activities. Each manufacturer shall establish
and maintain procedures for finished device acceptance to ensure that
each production run, lot, or batch of finished devices meets acceptance
criteria. Finished devices shall be held in quarantine or otherwise
adequately controlled until released. Finished devices shall not be
released for distribution until:
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(1) The activities required in the DMR are completed;
(2) the associated data and documentation is reviewed;
(3) the release is authorized by the signature of a designated
individual(s); and
(4) the authorization is dated.
(e) Acceptance records. Each manufacturer shall document acceptance
activities required by this part. These records shall include:
(1) The acceptance activities performed;
(2) the dates acceptance activities are performed;
(3) the results;
(4) the signature of the individual(s) conducting the acceptance
activities; and
(5) where appropriate the equipment used. These records shall be
part of the DHR.
Sec. 820.86 Acceptance status.
Each manufacturer shall identify by suitable means the acceptance
status of product, to indicate the conformance or nonconformance of
product with acceptance criteria. The identification of acceptance
status shall be maintained throughout manufacturing, packaging,
labeling, installation, and servicing of the product to ensure that only
product which has passed the required acceptance activities is
distributed, used, or installed.
Subpart I--Nonconforming Product
Sec. 820.90 Nonconforming product.
(a) Control of nonconforming product. Each manufacturer shall
establish and maintain procedures to control product that does not
conform to specified requirements. The procedures shall address the
identification, documentation, evaluation, segregation, and disposition
of nonconforming product. The evaluation of nonconformance shall include
a determination of the need for an investigation and notification of the
persons or organizations responsible for the nonconformance. The
evaluation and any investigation shall be documented.
(b) Nonconformity review and disposition. (1) Each manufacturer
shall establish and maintain procedures that define the responsibility
for review and the authority for the disposition of nonconforming
product. The procedures shall set forth the review and disposition
process. Disposition of nonconforming product shall be documented.
Documentation shall include the justification for use of nonconforming
product and the signature of the individual(s) authorizing the use.
(2) Each manufacturer shall establish and maintain procedures for
rework, to include retesting and reevaluation of the nonconforming
product after rework, to ensure that the product meets its current
approved specifications. Rework and reevaluation activities, including a
determination of any adverse effect from the rework upon the product,
shall be documented in the DHR.
Subpart J--Corrective and Preventive Action
Sec. 820.100 Corrective and preventive action.
(a) Each manufacturer shall establish and maintain procedures for
implementing corrective and preventive action. The procedures shall
include requirements for:
(1) Analyzing processes, work operations, concessions, quality audit
reports, quality records, service records, complaints, returned product,
and other sources of quality data to identify existing and potential
causes of nonconforming product, or other quality problems. Appropriate
statistical methodology shall be employed where necessary to detect
recurring quality problems;
(2) Investigating the cause of nonconformities relating to product,
processes, and the quality system;
(3) Identifying the action(s) needed to correct and prevent
recurrence of nonconforming product and other quality problems;
(4) Verifying or validating the corrective and preventive action to
ensure that such action is effective and does not adversely affect the
finished device;
(5) Implementing and recording changes in methods and procedures
needed to correct and prevent identified quality problems;
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(6) Ensuring that information related to quality problems or
nonconforming product is disseminated to those directly responsible for
assuring the quality of such product or the prevention of such problems;
and
(7) Submitting relevant information on identified quality problems,
as well as corrective and preventive actions, for management review.
(b) All activities required under this section, and their results,
shall be documented.
Subpart K--Labeling and Packaging Control
Sec. 820.120 Device labeling.
Each manufacturer shall establish and maintain procedures to control
labeling activities.
(a) Label integrity. Labels shall be printed and applied so as to
remain legible and affixed during the customary conditions of
processing, storage, handling, distribution, and where appropriate use.
(b) Labeling inspection. Labeling shall not be released for storage
or use until a designated individual(s) has examined the labeling for
accuracy including, where applicable, the correct expiration date,
control number, storage instructions, handling instructions, and any
additional processing instructions. The release, including the date and
signature of the individual(s) performing the examination, shall be
documented in the DHR.
(c) Labeling storage. Each manufacturer shall store labeling in a
manner that provides proper identification and is designed to prevent
mixups.
(d) Labeling operations. Each manufacturer shall control labeling
and packaging operations to prevent labeling mixups. The label and
labeling used for each production unit, lot, or batch shall be
documented in the DHR.
(e) Control number. Where a control number is required by
Sec. 820.65, that control number shall be on or shall accompany the
device through distribution.
Sec. 820.130 Device packaging.
Each manufacturer shall ensure that device packaging and shipping
containers are designed and constructed to protect the device from
alteration or damage during the customary conditions of processing,
storage, handling, and distribution.
Subpart L--Handling, Storage, Distribution, and Installation
Sec. 820.140 Handling.
Each manufacturer shall establish and maintain procedures to ensure
that mixups, damage, deterioration, contamination, or other adverse
effects to product do not occur during handling.
Sec. 820.150 Storage.
(a) Each manufacturer shall establish and maintain procedures for
the control of storage areas and stock rooms for product to prevent
mixups, damage, deterioration, contamination, or other adverse effects
pending use or distribution and to ensure that no obsolete, rejected, or
deteriorated product is used or distributed. When the quality of product
deteriorates over time, it shall be stored in a manner to facilitate
proper stock rotation, and its condition shall be assessed as
appropriate.
(b) Each manufacturer shall establish and maintain procedures that
describe the methods for authorizing receipt from and dispatch to
storage areas and stock rooms.
Sec. 820.160 Distribution.
(a) Each manufacturer shall establish and maintain procedures for
control and distribution of finished devices to ensure that only those
devices approved for release are distributed and that purchase orders
are reviewed to ensure that ambiguities and errors are resolved before
devices are released for distribution. Where a device's fitness for use
or quality deteriorates over time, the procedures shall ensure that
expired devices or devices deteriorated beyond acceptable fitness for
use are not distributed.
(b) Each manufacturer shall maintain distribution records which
include or refer to the location of:
(1) The name and address of the initial consignee;
(2) The identification and quantity of devices shipped;
(3) The date shipped; and
(4) Any control number(s) used.
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Sec. 820.170 Installation.
(a) Each manufacturer of a device requiring installation shall
establish and maintain adequate installation and inspection
instructions, and where appropriate test procedures. Instructions and
procedures shall include directions for ensuring proper installation so
that the device will perform as intended after installation. The
manufacturer shall distribute the instructions and procedures with the
device or otherwise make them available to the person(s) installing the
device.
(b) The person installing the device shall ensure that the
installation, inspection, and any required testing are performed in
accordance with the manufacturer's instructions and procedures and shall
document the inspection and any test results to demonstrate proper
installation.
Subpart M--Records
Sec. 820.180 General requirements.
All records required by this part shall be maintained at the
manufacturing establishment or other location that is reasonably
accessible to responsible officials of the manufacturer and to employees
of FDA designated to perform inspections. Such records, including those
not stored at the inspected establishment, shall be made readily
available for review and copying by FDA employee(s). Such records shall
be legible and shall be stored to minimize deterioration and to prevent
loss. Those records stored in automated data processing systems shall be
backed up.
(a) Confidentiality. Records deemed confidential by the manufacturer
may be marked to aid FDA in determining whether information may be
disclosed under the public information regulation in part 20 of this
chapter.
(b) Record retention period. All records required by this part shall
be retained for a period of time equivalent to the design and expected
life of the device, but in no case less than 2 years from the date of
release for commercial distribution by the manufacturer.
(c) Exceptions. This section does not apply to the reports required
by Sec. 820.20(c) Management review, Sec. 820.22 Quality audits, and
supplier audit reports used to meet the requirements of Sec. 820.50(a)
Evaluation of suppliers, contractors, and consultants, but does apply to
procedures established under these provisions. Upon request of a
designated employee of FDA, an employee in management with executive
responsibility shall certify in writing that the management reviews and
quality audits required under this part, and supplier audits where
applicable, have been performed and documented, the dates on which they
were performed, and that any required corrective action has been
undertaken.
Sec. 820.181 Device master record.
Each manufacturer shall maintain device master records (DMR's). Each
manufacturer shall ensure that each DMR is prepared and approved in
accordance with Sec. 820.40. The DMR for each type of device shall
include, or refer to the location of, the following information:
(a) Device specifications including appropriate drawings,
composition, formulation, component specifications, and software
specifications;
(b) Production process specifications including the appropriate
equipment specifications, production methods, production procedures, and
production environment specifications;
(c) Quality assurance procedures and specifications including
acceptance criteria and the quality assurance equipment to be used;
(d) Packaging and labeling specifications, including methods and
processes used; and
(e) Installation, maintenance, and servicing procedures and methods.
Sec. 820.184 Device history record.
Each manufacturer shall maintain device history records (DHR's).
Each manufacturer shall establish and maintain procedures to ensure that
DHR's for each batch, lot, or unit are maintained to demonstrate that
the device is manufactured in accordance with the DMR and the
requirements of this part. The DHR shall include, or refer to the
location of, the following information:
(a) The dates of manufacture;
(b) The quantity manufactured;
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(c) The quantity released for distribution;
(d) The acceptance records which demonstrate the device is
manufactured in accordance with the DMR;
(e) The primary identification label and labeling used for each
production unit; and
(f) Any device identification(s) and control number(s) used.
Sec. 820.186 Quality system record.
Each manufacturer shall maintain a quality system record (QSR). The
QSR shall include, or refer to the location of, procedures and the
documentation of activities required by this part that are not specific
to a particular type of device(s), including, but not limited to, the
records required by Sec. 820.20. Each manufacturer shall ensure that the
QSR is prepared and approved in accordance with Sec. 820.40.
Sec. 820.198 Complaint files.
(a) Each manufacturer shall maintain complaint files. Each
manufacturer shall establish and maintain procedures for receiving,
reviewing, and evaluating complaints by a formally designated unit. Such
procedures shall ensure that:
(1) All complaints are processed in a uniform and timely manner;
(2) Oral complaints are documented upon receipt; and
(3) Complaints are evaluated to determine whether the complaint
represents an event which is required to be reported to FDA under part
803 or 804 of this chapter, Medical Device Reporting.
(b) Each manufacturer shall review and evaluate all complaints to
determine whether an investigation is necessary. When no investigation
is made, the manufacturer shall maintain a record that includes the
reason no investigation was made and the name of the individual
responsible for the decision not to investigate.
(c) Any complaint involving the possible failure of a device,
labeling, or packaging to meet any of its specifications shall be
reviewed, evaluated, and investigated, unless such investigation has
already been performed for a similar complaint and another investigation
is not necessary.
(d) Any complaint that represents an event which must be reported to
FDA under part 803 or 804 of this chapter shall be promptly reviewed,
evaluated, and investigated by a designated individual(s) and shall be
maintained in a separate portion of the complaint files or otherwise
clearly identified. In addition to the information required by
Sec. 820.198(e), records of investigation under this paragraph shall
include a determination of:
(1) Whether the device failed to meet specifications;
(2) Whether the device was being used for treatment or diagnosis;
and
(3) The relationship, if any, of the device to the reported incident
or adverse event.
(e) When an investigation is made under this section, a record of
the investigation shall be maintained by the formally designated unit
identified in paragraph (a) of this section. The record of investigation
shall include:
(1) The name of the device;
(2) The date the complaint was received;
(3) Any device identification(s) and control number(s) used;
(4) The name, address, and phone number of the complainant;
(5) The nature and details of the complaint;
(6) The dates and results of the investigation;
(7) Any corrective action taken; and
(8) Any reply to the complainant.
(f) When the manufacturer's formally designated complaint unit is
located at a site separate from the manufacturing establishment, the
investigated complaint(s) and the record(s) of investigation shall be
reasonably accessible to the manufacturing establishment.
(g) If a manufacturer's formally designated complaint unit is
located outside of the United States, records required by this section
shall be reasonably accessible in the United States at either:
(1) A location in the United States where the manufacturer's records
are regularly kept; or
(2) The location of the initial distributor.
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Subpart N--Servicing
Sec. 820.200 Servicing.
(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 Sec. 820.100.
(c) Each manufacturer who receives a service report that represents
an event which must be reported to FDA under part 803 or 804 of this
chapter shall automatically consider the report a complaint and shall
process it in accordance with the requirements of Sec. 820.198.
(d) Service reports shall be documented and shall include:
(1) The name of the device serviced;
(2) Any 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.
Subpart O--Statistical Techniques
Sec. 820.250 Statistical techniques.
(a) Where appropriate, each manufacturer shall establish and
maintain procedures for identifying valid statistical techniques
required for establishing, controlling, and verifying the acceptability
of process capability and product characteristics.
(b) Sampling plans, when used, shall be written and based on a valid
statistical rationale. Each manufacturer shall establish and maintain
procedures to ensure that sampling methods are adequate for their
intended use and to ensure that when changes occur the sampling plans
are reviewed. These activities shall be documented.