21 CFR 820 and 801 pptx.pdf

QUALITY SYSTEM REQUIREMENT 21 CFR
PART 820
LABELING REQUIREMENT 21 CFR PART
801
BY:
BHAVIKA A. PATEL
ROLL NO. 29
MRA SEM II
K.B.I.P.E.R

BACKGROUND
SUBPARTS
REFERENCE
• SUBPART A General Provision
• SUBPART B Quality System Requirement
• SUBPART C Design Control
• SUBPART D Document Control
• SUBPART E Purchasing Control
• SUBPART F Identification and Traceability
• SUBPART G Production and Process control
• SUBPART H Acceptance Activities
• SUBPART I Nonconforming Product
• SUBPART J Corrective and Preventive Action
• SUBPART K Labelling And Packaging Control
• SUBPART L Handlin, Storage, distribution and Installation
• SUBPART M Records
• SUBPART N Servicing
• SUBPART O Statistical Techniques
C
O
N
T
E
N
T

•Eﬀec&ve June 1,1997, replacing the
1978 GMP for medical devices
•Preamble to the 1997 regula&on-
very Important
•Requirements are not prescrip&ve
•Provides frame work of basic
requirements for manufacturer to
manufacturers to follow
B
A
C
K
G
R
O
U
N
D

SUBPART K
LABELING AND PAKAGING
CONTROL
• 820.120 Device Labeling
• 820.130 Device Packaging
SUBPART L
HANDLING,STORAGE,DISTRIBUTI
ON AND INSTALLATION
• 820.140 Handling
• 820.150 storage
• 820.160 Distribution
• 820.170Installation
SUBPART M
RECORDS
• 820.180General requirement
• 820.181Device master record
• 820.184Device histrory record
• 820.186Quality system record
• 820.198Complaints file
SUBPART N
SERVICING
• 820.200Serrvicing
SUBPART O
STATISTICAL TECHNIQUES
• 820.250 Statistical Techniques
SUBPART F
IDENTIFICATION AND
TRACEABILITY
• 820.60 Identification
• 820.65 traceability
SUBPART G
PRODUCTION AND
PROCESS CONTROL
•820.70 production and
process
•820.72 Inspection
,measuring & test
equipment
•820.75 Process validation
SUBPART H
ACCEPTANCE
ACTIVITIES
•820.80 Scope
•820.86 Receiving, in
process and finished
device acceptance
SUBPART I
NON CONFORMING
PRODUCT
•820.90 Non-conforming
product
SUBPART J
CAPA
•820.100 CAPA
SUBPART A
GENERAL PROVISION
•820.1 Scope
•820.3 Definition
•820.5 Quality system
SUBPART B
QUALITY SYSTEM
REQUIREMENTS
•820.20 Management
responsibility
•820.22 Quality Audit
•820.25 Personnel
SUBPART C
DESIGN CONTROL
•820.30 Design control
SUBPART D
DOCUMENT CONTROL
•820.40 Document
control
SUBPART E
PURCHASING CONTROL
•820.50 Purchasing
Control

SUBPART A
GENERAL PROVISION
a) APPLICABILITY
• cGMP requirement in this part govern the method used in , and the facilities and
control used for ,the design, manufacture, packaging, Labeling ,storage, installation
,and servicing of all finished devices intended for human use
• Intended to ensure that finished device is safe and effective otherwise in
compliance with federal food , drug , and cosmetics Acts.
• Does not apply to manufacturer of components or parts of finished devices
• Does apply to contact manufacturer of medical devices – if you use contact
manufacturer, make sure they are registered with FDA
b) AUTHORITY
• The failure to comply with any applicable provision in this part renders advice
adulterated under section 505(h) of the act such a device as well as any personal
responsible for the failure to comply ,is subject to regulatory action
820.1
SCOPE

820.3 DEFINITION
SUBPART A
GENERAL PROVISION
• federal food, drug , cosmecHcs Acts
ACTS
• 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
COMPLAINTS
• means any raw material, substance, place, part, software, firmware, labeling, or
• assembly which is intended to be included as part of the finished, packaged, and
labeled device
COMPONENT
• 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
CONTROL NUMBER
• means a compilaHon of records which describes the design history of a ﬁnished
device
DESIGN HISTORY FILE (DHF)

• The physical performance requirement of a device that used as a basis for device
design.
DESIGN INPUT
• 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
DESIGN OUTPUT
• 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.
DESIGN REVIEW
• a compilation of records containing the production history of a finished device.
DEVICE HISTORY RECORD (DHR)
• document (in wriHng or electronically), and implement
ESTABLISH
• 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
FINISH DEVICE
• 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
LOT OR BATCH

• Those senior employees of a manufacturer who have me authority to establish or
make changes to the manufacturer's quality policy and quality system
MANAGEMENT WITH EXECUTIVE
RESPONSIBILITY
• any person who designs, manufactures: fabricates assembles or processes a
finished device Manufacturer includes but is not limited to those who perform the
funcHons of contract sterilizaHon, installaHon, relabeling remanufacturing
repacking, or specificaHon development and iniHal distributors of foreign enHHes
performing these funcHons
MANUFACTURER
• 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.
MANUFACTURING MATERIAL
• The non- fulfillment of a specified requirement. (r) Product means components,
manufacturing materials, in-process devices, finished devices and returned devices.
NON-CONFORMITY
• The totality of features and characteristics that bear on the ability of a device t
satisfy fitness-for-use, including safety and performance.
QUALITY
• a systemaHc, independent examinaHon of a manufacturer's quality system that is
performed at defined intervals and at sufficient frequency to determine whether
both quality system acHviHes and the results of such acHviHes comply with quality
system procedures, that these procedures are implemented effecHvely, and that
these procedures are suitable to achieve quality system objecHves.
QUALITY AUDIT

• the overall intentions and direction of an organization with respect to quality, as
established by management with executive responsibility
Quality policy
• 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 specified
Quality system
• many 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
Remanufacturer
• action taken on a nonconforming product so that it will fulfill the DMR
requirements before it is released for distribution
Rework
• any requirement with which a product, process, service, or other activity must
conform.
Specification
• Confirmation by examination and provision of objective evidence that the particular
requirements for a specific intended use can be consistently fulfilled
ValidaNon

SUBPART B
QUALITY SYSTEM
REQUIREMENT
820.20 MANAGEMENT RESPONSIBILITY
A. QUALITY POLICY:
Ø Quality policy is established by management with executive
responsibility and it should addresses the quality.
Ø Management 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

SUBPART B
QUALITY SYSTEM
REQUIREMENT
3. Management representative- Management with executive responsibility
shall appoint and document such appointment of a member of management
who, irrespective of responsibilities, shall have established authority over and
responsibility.
I Ensuring that quality system requirements are effectively established and
effectively maintained
II Reporting on the performance of the quality system to management.
4. Management review-
Ø Management shall review the effectiveness of the quality system.
Ø The dates and results of quality system reviews shall be documented.
5. 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.
6. 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.

SUBPART B
QUALITY SYSTEM
REQUIREMENT
820.22 QUALITY AUDIT
Ø To assure that the quality system.
Ø Compliance with requirements.
Ø Conducted by individuals- do not have direct responsibility.
Ø Corrective action(s), including a re-audit of deficient matters.
Ø The dates are recorded.
820.25. PERSONNEL
• General- Every Personnel should be educated, trained, and experience to assure
that all activities required by this part are correctly performed
• 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 acti vities shall be made
aware of defects and errors that may be encountered as part of their job
functions

DESCRIBES THE DESIGN
PLANNING
DESIGN REQUIREMENTS
CONFORMANCE TO
DESIGN INPUT
CONDUCTED AT
APPROPRIATE STAGES
OUTPUT MEET
INPUTS
VALIDATE THE OUTPUT
PRODUCTION
SPECIFICATION
DESIGN CHANGE
BEFORE
IMPLEMENTATION
DEMONSTRATE THE
HISTORY OF DEVICES

SUBPART C
DESIGN CONTROL
820.30 DESIGN CONTROL
q FDA requires design control for all:
• Class II and Class III devices
• Class I devices that contains software and
• ‘listed’ devices :
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 Tele-therapy.
Design Controls are not "one and done". Meant to be iterative process and living documents
1. Design History File (DHF):
Ø Establish and maintain a design history file
Ø Contain or reference the records necessary to demonstrate that the design was
developed in accordance with the approved design plan, and with the Quality System Regulation
Ø Objective evidence "proof of what was done
2. Design Planning
Ø Establish and maintain plans for activities
Ø Define responsibilities
Ø Describe interfaces between groups/activities Review, approve, and update as design evolves

SUBPART C
DESIGN CONTROL
3. Design Inputs
Ø Establish and maintain procedures
Ø Ensure design requirements are appropriate and address the intended use of the device, including the
needs of the user and patient
Ø Mechanism for addressing incomplete, ambiguous or conflicting requirements
Ø Requirements are documented, reviewed, and approved
Ø Approval includes signature and date
4. Design Outputs:
Ø Establish and maintain procedures for defining and documenting output in terms that allow an adequate
evaluation of conformance to design input requirements.
Ø Procedure contains (or refers to) acceptance criteria
Ø Procedure ensures that outputs essential for the proper functioning of the device are identified Design
outputs are documented, reviewed and approved before release
Ø Approval includes signature and date
5. Design Verification:
Ø Confirm that the design outputs meet the design input requirements.
Ø Results of verification are documented in the design history file, including
o Identification of the design
o Methods
o Date
o Individuals performing verification
6. Clarification:
Ø Design verification-verify that outputs meet inputs (bench-top)
Ø Design validation-verify that design meets user needs and the intended use (actual or simulated conditions of
use)

SUBPART C
DESIGN CONTROL
7. Design Validation:
Ø Performed "under defined operating conditions on initial production units, lots, or batches, or their
equivalents".
Ø Ensures that devices conform to the defined user needs and Intended uses
Ø Includes testing of production units under actual or simulated uses conditions
Ø Includes software validation, where appropriate
Ø Includes risk analysis, where appropriate Results of review are documented in the design history file,
including:
o Identification of the design
o Methods
o Date
o Individuals performing review
8. Design Transfer:
Ø Each manufacturer shall establish and maintain procedures to ensure that the device design is correctly
translated to production specifications
Ø Identify and define production processes, procedures and controls
Ø Device is consistently manufacturable to established specifications.
9. Design Changes
Ø Establish and maintain procedures for the identification documentation, validation (or where appropriate,
the verification), review, and approval of design changes before their implementation
Ø Design changes must be controlled throughout product lifecycle (pre and post-transter)
Clarification
Ø DHF design history file.
Ø DHR device history record (batch record)
Ø DMR device master record(master instructions)

SUBPART D
DOCUMENT CONTROL
820.40 DOCUMENT CONTROLS
q 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:
Ø To meet the requirements.
Ø Including the date and signature of the individual(s)
approving the document.
b) Document changes.
Ø Changes shall be reviewed & approved by Individual(s).
Ø Changes should be communicated the Appropriate Personnel
Properly

SUBPART E
PURCHASINGCONTROL
b) Purchasing data:
Ø Quality data of the purchased product should be collected
820.50 PURCHASING CONTROLS:
a) Evaluation of suppliers, contractors, and consultants:
Ø Maintain the Quality Requirements.
Ø Select potential suppliers, contractors, and consultants.
Ø Maintain records of acceptable suppliers, contractors, a consultants.

SUBPART F
IDENTIFICATION
AND
TRACEABILITY
820.60 Identification:
o Identifying Products at all the stages:
o Receipts
o Production
o Distribution &
o Installation
820.65 Traceability:
Identifying with a Control Number each unit,
Lot, or Batch Number.

SUBPART G
PRODUCTION AND PROCESS CONTROLS:
820.70 PRODUCTION AND PROCESS CONTROLS:
Ø Develop, conduct, control, and monitor production processes.
Ø Maintain control procedures.
Ø Process Controls includes:
1. Documented instructions, standard operating procedures (SOP's), and methods.
2. Monitoring, Control of process parameters, Components, Device characteristics.
3. Compliance with specified standards.
4. Approval of processes and process equipment.

CHANGES SHALL BE VERIFIED,
BEFORE IMPLEMENTATION
ADEQUATELY
CONTROL THESE
ENVIRONMENTAL
CONDITIONS
PREVENT
CONTAMINATION OF
EQUIPMENT OR
PRODUCT
MAINTAIN THE PLACE
AND EVERYTHING
CLEAN
MAINTAIN THE
QUALITY OF THE
MATERIALS
INSPECT THE
EQUIPMENT ‘S
QUALITY
ALL SOFTWARE
SHOULD BE
VALIDATED
HEALTH, CLEANESS,
PERSONAL
PRACTICES, AND
,CLOTHING
SUFFICIENT SPACE TO
PERFORM NECESSARY
OPERATION
SPECIFIED
REQUIREMENTS FOR
MANUFACTURING

SUBPART H
ACCEPTANCE ACTIVITIES
820.80-Receiving, In-Process and Finished Device Acceptance
• Establish and Maintain Procedures And Records
•Records includes:
•(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.
820.86-Acceptance Status
• Suitable Means of Identification

Control of
non-
conforming
product.
Ø Establish and maintain procedures to control product that does not conform to
specified requirements
Ø The procedures shall address the identification, documentation, evaluation,
segregation, and disposition of nonconforming product.
Ø It includes a determination of the need for an investigation and notification of the
persons or organizations responsible for the nonconformance. And shall be
documented
Nonconformity
review and
disposition.
(1) Establish and maintain procedures that define the responsibility
Ø To review and the authority for the disposition of nonconforming product
Ø Disposition of nonconforming product shall be documented.
Ø include the justification for use of nonconforming product and the signature of the
individual(s) authorizing the use.
(2) establish and maintain procedures for rework,
Ø To include retesting and reevaluation of the nonconforming product after rework
Ø To ensure that the product meets its current approved specifications.
Ø Disposition of nonconforming product shall be documented
SUBPART I
NON CONFORMING PRODUCT

SUBPART J
CURRECTIVE AND PREVENTIVE
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.
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;
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.

z
SUBPART K
LABELING AND PACKAGING
820.120
Device labeling
o Any Written or Displayed Information Applied on or Accompanying the Device:
• Description for Use, Cautions/Warnings, Manuals, etc.
o Label Integrity, Inspection, Storage, Control Numbers, Labeling Operations
o Label integrity- to remain legible and affixed during the customary conditions of processing,
storage, handling, distribution, and where appropriate use.
o 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
unique device identifier (UDI) or universal product code (UPC), 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.
o Labeling storage- store labeling in a manner that provides proper identification and is
designed to prevent mixups.
o Labeling operations- 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.
820.130
Device packaging
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
ANDINSTALLATION
820.140 Handling- To ensure that mixups, damage, deterioration, contamination, or other
adverse effects to product do not occur during handling .
820.150 Storage-
Ø Control of Storage Areas, Stock room.
Ø describe the methods for authorizing receipt from and dispatch to storage areas and
stock rooms.
820.160 Distribution-
Ø Each manufacturer shall maintain distribution records which include or refer to the location
of:
o The name and address of the initial consignee
o The identification and quantity of devices shipped
o The date shipped
o Control number
820.170 Installation
Ø Distribute the instructions and procedures
Ø Person installing the device-Ensure the Procedure

SUBPART
M
RECORDS
820.180 GENERAL REQUIREMENT
Ø Made available to the FDA for review
Ø Confidentiality
Ø Record retention period- 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.
Ø Exception
o Management review
o Audit reports
o Supplier audit reports
820.181 Device Master Records (DMR)
Ø Recipe for the Device
Ø Specifications of production process, method, procedure and environment
Ø QA Procedures Specifications
Ø Instalation specification
Ø Packaging and labeling specification including Procedures etc.
820.184 Device history record. (DHR
Ø The device is manufactured in accordance with the DMR
Ø DHR include following information
o Date of Manufacture
o Quantity Manufactured
o Quantity Released for Distribution Acceptance Records
o Labeling
o Control Numbers

SUBPART
M
RECORDS
820.186 Quality System Record
Includes/Refers to the Location of Records Required by the QSR Records of Audits, Management Reviews, etc.
820.198 Complaint files
Ø 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
3) Complaints are evaluated to determine whether the complaint represents an event which is
required to be reported to FDA
Ø review and evaluate all complaints to determine whether an investigation is necessary. If no
investigation is made then maintain a record that include reason for no investigation was made.
Ø 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.
Ø The record of investigation shall include:
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) 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.

SUBPART
N-SERVICING Ø 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.
Ø Service reports shall be documented and shall include:
(1)The name of the device serviced;
(2) Unique Device Identifier (UDI) or Universal Product Code
(UPC), and any other device identification(s) and control
number(s);
(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.
820.250
STATISTICAL
TECHNIQUES Ø Establish and maintain procedures for identifying valid statistical techniques
required for establishing, controlling, and verifying the acceptability of
process capability and product characteristics.
Ø 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.

https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-O/section-820.250
https://www.slideshare.net/GayathriGuhan/21-cfr-820pptx
REFERENCES

LABELING REQUIREMENT 21
CFR PART 801

C
O
N
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E
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BACKGROUND
SUBPARTS
REFERENCE
• SUBPART A General Labeling Provision
• SUBPART B Labeling Requirements for Unique Device Identification
• SUBPART C Labeling Requirements for Over-the-Counter Devices
• SUBPART D Exemptions From Adequate Directions for Use
• SUBPART E Other Exemptions
• SUBPART F-G Reserved
• SUBPART H Special requirement for specific Devices

WHAT IS
“LABEL”
Ø A display of written, printed, or graphic matter
upon the immediate container of any article.
Ø Any word, statement, or other information that
appears on the label shall also appear on the
outside container or wrapper of the retail
package or is easily legible through the outside
container or wrapper
INTRODUCTION

Labeling regulations pertaining to medical
devices are found in the following parts of
Title 21 of the Code of Federal Regulations.
General Device Labeling:
21 CFR Part 801
LABELING REGULATION

v 801.1 MEDICAL DEVICE; NAME, PLACE OF BUSINESS OF
MANUFACTURER, PACKER AND DISTRIBUTORS
Ø must be included on the package label
- Name and place of the manufacturer, distributors, or packer
- Where a device is not manufactured by the person whose name appears on
the label, the name shall be qualified by a phrase that reveals the
connection such person has with such device; such as, “Manufactured for
___”, “Distributed by _____”, or any other wording that expresses the
facts.
- The statement of the place of business shall include the street address, city,
State, and Zip Code;
SUBPART A
GENERAL LABELING PROVISION

v 801.3 Definition
1. Automatic identification and data capture (AIDC): means any technology that conveys the
unique device identifier or the device identifier of a device in a form that can be entered into an
electronic patient record or other computer system via an automated process
2. Center Director: means the Director of the Center for device and Radiological Health (CDRH) or the
Director of the Center for Biologics Evaluation and Research (CDBR), depending on which Center
has been assigned lead responsibility for the device
3. Convenience kit : means two or more different medical device packaged together for the
convenience of the user.
SUBPART A
GENERAL LABELING PROVISION

v 801.3 Definition
4. Device package: means a package that contains a fixed quantity of a
particular version or model of a device.
5. Finished device: means any device or accessory to any device that is suitable for use or capable of functioning.
6. Global Unique Device Identification Database (GUDID) : means a database administered
by the FDA that will serve as a reference catalog for every medical device with
a unique device identifier (UDI).
SUBPART A
General Labeling Provision

SUBPART A

7. Labeler means: Any person who causes a label to be applied to a device with the intent that the device will be
commercially distributed without any intended subsequent replacement or modification of the label;
8. Lot or batch: means one finished device or more 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.
9. Shipping container: means a container used during the shipment or transportation of devices, and whose contents
may vary from one shipment to another.
10. Specification: means any requirement with which a device must conform.
11. Unique device identifier (UDI): means an identifier that adequately identify medical devices sold in the United States
from manufacturing through distribution to patient use.
a) Device Identifier - a mandatory, fixed portion of a UDI that identifies the specific version or model of
a device and the labeler of that device; and
b) A Production Identifier - a conditional, variable portion of a UDI that identifies one or more of the following
when included on the label of the device:
(i) The lot or batch within which a device was manufactured;
(ii) The serial number of a specific device;
(iii) The expiration date of a specific device;
(iv) The date a specific device was manufactured;
SUBPART A

12. Universal product code (UPC): means the product identifier used to identify an item sold at retail in the United States.
13. Version or model: means all devices that have specifications, performance, size, and composition, within limits set by
the labeler.
801.5 Medical devices; adequate directions for use.
Ø It means directions under which the layman can use a device safely and for the purposes for which it is intended.
Ø Section 801.4 defines intended use means the general purpose of the device or its function, and encompasses the
indications for use;
Ø Directions for use may be inadequate because, among other reasons, in whole or in part, or incorrect specification of:
a) Quantity of dose, including usual quantities for each of the uses for which it is intended and usual quantities for
persons of different ages and different physical conditions.
b) Frequency of administration or application.
c) Duration of administration or application.
d) Time of administration or application, in relation to time of meals, time of onset of symptoms, or other time factors.
e) Route or method of administration or application.
f) Preparation for use, i.e., adjustment of temperature, or other manipulation or process.
SUBPART A

801.6 Medical devices; misleading statements.
Ø A device is misbranded if it makes a false or misleading statement with respect to another device, drug,
food, or cosmetic.
801.18 Format of dates provided on a medical device label.
Ø the label of a medical device includes:
• Device name
• Manufacturer name and address
• Lot or batch number
• Quantity of devices in package
• expiration date,
• date of manufacture, or
• any other date intended to be brought to the attention of the user of the device,
• the date must be presented in the following format: presented as 2014–01–02.
SUBPART A

• a device label and device package must bear a UDI that meets requirements of this parts
801.20 Label to bear a unique device identifier
• Class I cGMP excepted devices
• Individual single-use devices and stored in a single package until removed for use
• IDES or devices used solely for nonclinical use
• Devices intended solely for export from the US
• Individual devices in convenience kits
• Three year prior marketed devices
• FDA may grant exception or alternative
• National Drug Code (NDC) Numbers-If combination product properly bear an NDC number on its label
than products is not required UDI
801.30 General exceptions from the requirement for the
label of a device to bear a unique device identifier

• a labeler voluntarily includes a UDI for a device, the labeler may voluntarily provide information
concerning the device under subpart E of part 830
801.35 Voluntary labeling of a device with a unique device identifier.
• The UDI must be presented in two forms:
• (1) Easily readable plain-text, and
• (2) Automatic identification and data capture (AIDC) technology.
• If the AIDC technology is not evident upon visual examination of the label or device package, the label
or device package must disclose the presence of AIDC technology.
801.40 Form of a unique device identifier.
• (a) Devices must bear permanent marking providing the UDI on the device,if
• Intended to be used more than once
• Intended to be reprocessed before each use
• (b) Direct marking requirements shall not apply to any device that meets any of the following criteria:
• Not technologically feasible
• Device is a single-use device and is subjected to additional processing and manufacturing for the purpose of an
additional single use
• Would interfere with the safety or effectiveness
801.45 Devices that must be directly marked with a unique device identifier.

• Stand-alone software that is not distributed in packaged form (e.g., when downloaded from a Web site) is deemed
to meet the UDI labeling requirements of this subpart.
• it is or is not distributed in packaged form, stand-alone software regulated as a medical device must provide its
unique device identifier through either or both of the following:
• (1) An easily readable plain-text statement displayed whenever the software is started;
• (2) An easily readable plain-text statement displayed through a menu command.
801.50 Labeling requirements for stand-alone software.
• A labeler may submit a request for an exception from or alternative to the requirement of bear a UDI
• If requesting an alternative, describe the alternative and explain why it would provide for more accurate, precise,
or rapid device identification than the requirements of this subpart or how the alternative would better ensure
the safety or effectiveness of the device that would be subject to the alternative;
• A written request for an exception or alternative must be submitted by sending it:
• If the device is regulated by the Center for Biologics Evaluation and Research (CBER), BY EMAIL TO :
cberudirequests@fda.hhs.gov
• The Center Director may grant an exception or alternative, either in response to a request or on his or her own
initiative.
801.55 Request for an exception from or alternative to a
unique device identifier requirement.

• On the date your device must bear a unique device identifier (UDI) on its
label, any National Health-Related Item Code (NHRIC) or National Drug Code
(NDC) number assigned to that device is rescinded, and you may no longer
provide an NHRIC or NDC number on the label of your device or on any
device package.
801.57 Discontinuation of legacy FDA identification
numbers assigned to devices.

SUBPARTS C
Labeling Requirements for Over -The – Counter Devices
801.60 Principal Display Panel
• The principal display panel is that
portion of the label which is
intended to be displayed, presented,
shown, or examined under
customary conditions for retail sales.
The area of the principal display
panel is considered to be:
• In the case of a rectangular
package, the height x width of one
side;
• In the case of a cylindrical or
nearly cylindrical package, 40% of
height x circumference; or
• In the case of any other shapes,
40% of the total surface area of
the container, unless a more
prominent site exists.
801.61 Statement of Identity
• The statement of identity of the
device must be listed on the
principal display panel.
• It must list the common name of
the device followed by a
statement of its principal intended
action(s);
• Indications for use must be listed
in the directions for use; and
• The statement must be in bold
type, reasonably related in size to
the most prominent printed
matter on the display panel, and
must be in lines generally parallel
to the base of the package on
which it rests.
801.62 Net Quantity of Contents
Statement
• The label of an over-the-counter
(OTC) device in package form must
contain a statement of net quantity
of contents in terms of weight,
measure, numerical count; or a
combination of numerical count and
weight, measure, or size

q 801.109 Prescription Devices
ü The device is in the possession of either a licensed practitioner or persons lawfully engaged in the manufacture
or distribution of the product;
ü its labeling bears an Rx statement, e.g. "Caution: Federal law restricts this device to sale by or on the order of a
(insert name of physician, dentist, or other licensed practitioner)";
ü its labeling bears information for use, including indications, effects, routes, methods, and frequency and
duration of administration, and relevant hazards, contraindications, side effects, and precautions under which
the device can safely be used; and
ü all labeling other than labels and cartons bears the date of issuance or date of the latest revision.
q 801.110 Retail Exemption
ü A device which is delivered to the ultimate user by a licensed practitioner in the course of their practice or
upon prescription are required only to bear the name and address of the practitioner, directions for use, and
any required cautionary statements.
q 801.116 Commonly Know Directions
ü A device is exempt from adequate directions for use if adequate directions for common uses are known to the
ordinary individual.
SUBPARTS D
Exemptions From Adequate Directions For Use

q 801.119 In Vitro Diagnostics
o IVDs LABEL REQUIREMENG
• The established and proprietary names of the product
• The intended use or uses*
• A statement of warnings or precautions for users and a statement "For In
Vitro Diagnostic Use"*
• Name and place of business of the manufacturer, packer, or distributor
• Lot or control number traceable to the production history
ü Multiple unit products must have traceability of the individual units
ü Instrument lot numbers must allow for traceability of subassemblies
ü A multiple unit product that requires use of its components as a
system should units
SUBPARTS D

q 801.119 In Vitro Diagnostics
SUBPARTS D
o FOR REAGENTS*:
• Established (common or usual) name
• Quantity, proportion, or concentration of all active ingredients
• Storage instructions, i.e., temperature, humidity, etc.
• Instructions for manipulation of products requiring mixing or
reconstitution
• Means to assure that the product meets appropriate standards of purity,
quality, etc., at the time of use, including one or more of the following:-
- expiration date (date beyond which the product is used)not to be
- statement of any visual indication of alteration*
- instructions for a simple check to assure product usefulness*
• The net quantity of contents*

q 801.122 Medical Devices Used in Manufacturing
• Devices used for processing, repacking, or manufacturing of another drug or device are exempt from adequate
directions for use if they bear the statement: "Caution: For manufacturing, processing, or repacking."
q 801.125 Medical Devices Used in Teaching, Research, or Law
Enforcement
• Devices for use in teaching, law enforcement, research, and analysis are exempt if the device is shipped or sold
to, or in the possession of, persons lawfully engaged in instruction in pharmacy, chemistry, or medicine (not
involving clinical use), law enforcement, or chemical analysis or physical testing.
q 801.127 Expiration of Exemptions
• Exemptions from adequate directions for use are terminated:
- If devices are shipped to individuals other than those who are listed as exempt, or
- If the devices are used for other than the exempted purposes.
SUBPARTS D

q 801.150 Medical devices; processing, labeling, or repacking
• In-process devices that are being transported (in transit) from
one manufacturing site to another are exempt if:
o The person who introduced the product into commerce is
the operator of the firm where the device is to be further
processed.
o The person introducing the product into commerce is not
the operator, and the delivery is to be made under a
written agreement which includes the names and
addresses of the firms and listing those specifications
necessary for further processing.

• The shipments are unsterile devices, are labeled as sterile, are in transit
to a contract sterilizer and are exempt only if both of the following are
met:
(1) There is in effect a written agreement between the two parties
containing:
o names and addresses of both parties which is signed by both the
person authorizing the shipment and the person in charge of the
sterilization facility;
o instructions for maintaining records to insure total accountability;
o acknowledgment that the devices are non sterile and being
shipped for further processing;
o a statement detailing the sterilization process, sterilant media,
equipment, and quality assurance controls to be used

• Certain devices require specific labeling which may include not
only package labeling, but informational literature, patient release
forms, performance testing, and/or specific tolerances or
prohibitions on certain ingredients. The following devices have
additional labeling requirements:
o 801.405 Denture repair or refitting kits - Special labeling and
directions are listed in this section.
o 801.410 Impact resistant lenses in sunglasses and eyeglasses -
This section specifies that case hardening of glass lenses,
statistical testing of plastic lenses, "drop ball" testing, and
documentation of these activities are required.

o 801.415 Ozone emission levels - This section specifies that ozone emission is
restricted to levels below 0.05 parts per million in certain devices, and not
permitted at all for use in any medical conditions for which there is no proof
of safety or efficacy.
o 801.417 Chlorofluorocarbon propellants - This section specifies the use is
prohibited except for use in contraceptive foams and certain metered drug
dosage forms as detailed under 21 CFR 2.125. Special labeling is required on
devices using this propellant as listed under 801.425.
o 801.420 Hearing aids - Labeling requirements related to warnings, directions
to dispensers and users, and technical data are contained in this section.
Conditions for sale requirements related to availability of instructional
brochures, patient waivers, and record keeping requirements are contained
in 21 CFR 801.421.

o 801.430 Menstrual tampons - This section contains those labeling
requirements related to Toxic Shock Syndrome (TSS) information,
warnings, and advisories.
o 801.433 Chlorofluorocarbons or other ozone depleting
substances - This section contains specific warning statements for
all prescription and restricted devices containing or manufactured
with chlorofluorocarbons, halons, carbon tetrachloride, methyl
chloride, or any other Class I substance designated by the U.S. EPA.

o 801.435 Latex condoms - This section contains specific
requirements for user labeling including data related to natural
integrity, expiration dating requirements, storage conditions and
inclusion of spermicidal ingredients.
o 801.437 Devices containing natural rubber - This section contains
information related to the definitions of latex, natural rubber, and
human contact and specific informational and caution
requirements and restrictions related to the composition of the
device.

REFERENCES
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H
https://www.fda.gov/medical-devices/device-labeling/general-device-labeling-
requirements

21 CFR 820 and 801 pptx.pdf

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