This guidance was written prior to the February 27, 1997 implementation of FDA's 
Good Guidance Practices, GGP's. It does not create or confer rights for or on any person 
and does not operate to bind FDA or the public. An alternative approach may be used if 
such approach satisfies the requirements of the applicable statute, regulations, or both. 
This guidance will be up dated in the next revision to include the standard elemnt s of GGP 's .  Labeling 
Regulatory Requirements for Medical Devices 
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 
Public Health Service 
Food and Drug Administration  CDRH PUBLICATIONS - MEDICAL DEVICES 
Publications of the Center for Devices and Radiological Health (CDRH) are available as paper 
copies from either the U.S. Government Printing Office (GPO) or the National Technical Information 
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microfiche, at $1.35 each, you may establish a deposit account with NTIS and request automatic 
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Addresses for ordering are:  Superintendent of Documents, U.S. Government Printing Office, 
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FDA 85-4199  Medical Device Establishment Registration:  Information and Instructions (PB 86- 
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(supersedes FDA 83-4159) (PB 86-184942/AS, $16.95). 
FDA 86-4163  Registration and Listing - Regulatory Requirements for Medical  Devices (April 
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FDA 86-4201  Problem Definition Study:  Rubella Antibody Testing (PB 86-131935/AS, $9.95, 40 
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FDA 86-4202  To Cement or Not to Cement?  or Has the FDA Approved the Use of This Device? 
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FDA 86-4203  Labeling - Regulatory Requirements for Medical Devices (GPO 017-012-00327-3, 
$2.75) (PB 86-184348/AS, $11.95). 
FDA 86-4204  An Interlaboratory Comparison of Analytical Methods for Ethylene Oxide (PB 86- 
181856/AS, $9.95). 
FDA 86-4205  Accidental Breathing Systems Disconnections (January 1986lFinal Report) (PB 86- 
185204/AS, $22.95). 
(Continued on inside back cover)  HHS Publication FDA 89-4203 
Labeling 
Regulatory Requirements for Medical Devices 
Prepared by the 
Division of Small Manufacturers Assistance 
Office of Training and Assistance 
Project Officer 
Thomas Cardamone 
August 1989 
(This publication supersedes FDA 86-4203) 
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES 
Public Health Service 
Food and Drug Administration 
Center for Devices and Radiological Health 
Rockville, Maryland 20857 
For sale by the Superintendent of Documents, U.S.G overnment Printing Office, Washington, D.C. 20402  FOREWORD 
In  October  1982,  the  Food  and  Drug  Administration  established  the  Center  for 
Devices and Radiological Health (CDRH) by  merging the Bureau of  Medical Devices and 
the Bureau of  Radiological Health. 
The Center develops and implements national programs to protect the public health 
in the fields of  medical devices and radiological health.  These programs are intended to 
assure  the  safety,  effectiveness and  proper  labeling  of  medical  devices,  to  control 
unnecessary human exposure to potentially hazardous ionizing and nonionizing radiation, 
and to ensure the safe, efficacious use of  such radiation. 
The  Center publishes the results of  its work  in  scientific journals  and  in  its own 
technical  reports.  These  reports  provide  a  mechanism  for  disseminating  results  of 
CDRH and contractor projects.  They are sold by the Government Printing Office and/or 
the National Technical Information Service. 
We  welcome your comments and requests for further information. 
ohn C. Villfo  h 
b'D irector 
Center for Devices and 
Radiological Health  PREFACE 
This publication  explains  label  and  labeling  regulations  and  requirements  for 
medical devices.  The  Food  and  Drug  Administration  has  many  labellfig-related 
requirements to help assure that devices are used safely and effectively,  including, 
but not limited to, provisions on misbranding in Section 502 of  the Food, Drug, and 
Cosmetic (FDhC) Act.  This publication explains such topics as advertising matter 
as  labeling,  what  is  false  and  misleading  labeling,  how  prominent  labeling 
information must be, what inforfiation must appear on containers as well as outside 
labels,  adequate directions for dbe,  prescription  device requirements,  and  special 
labeling for particular devices or types of devices and uses. 
The Medical Device Amendmhts to the FD&C Act mandated the establishment 
of  "...an  identifiable office to ptovide technical and other non-financial  assistance 
to small  manufacturers  of  medical devices to assist  them  in  complying with  the 
requirements  of  the  Food,  Drug,  and  Cosmetic  Act."  The  Division  of  Small 
Manufacturers Assistance (DSMA) was established to meet these requirements.  In 
addition to providing individual guidance and workshops,  DSMA  distributes a wide 
variety of  printed  materials such as regulations,  policy  statements,  question-and- 
answer booklets, and other FDA documents that help manufacturers understand the 
substance  and  impact  of  FDA  requirements,  as  well  as  the  simplest  or  most 
effective ways to meet them.  This publication contains explanations and examples 
of ways that companies can readily comply with labeling requirements.  We hope the 
information contained in this publication will alert manufacturers to FDA  labeling 
requirements, and prompt them to ask any questions they may have.  Feel free to 
visit,  write,  or call DSMA  toll free at 800-638-2041.  The local phone  number  is 
(301) 443-6597. 
V 
Joseph 9. Arcarese 
Director 
Office of Training and Assistance  ABSTRACT 
Division of  Small Manufacturers Assistance,  Office of  Training and Assistance,  Center 
for Devices and  Radiological Health.  Labeling:  Regulatory  Requirements for Medical 
Devices.  HHS Publication FDA 89-4203  (August 1989) (pp. 43). 
This publication is Chapter 6 of  the "Regulatory  Requirements  for Medical 
Devices - A  Workshop  Manual."  It  covers  labeling requirements  that  device 
manufacturers,  reconditioners,  repackers,  and relabelers  must  consider when  a 
product requires labeling.  Such labeling may  include adequate instructions for 
use, servicing instructions, adequate warnings against uses that may be danger- 
ous to health, or information that may be necessary for the protection of users.  CONTENTS 
Page 
..................................................... 
Foreword  i i 
...................................................... 
Preface  iii 
..................................................... 
Abstract  iv 
............................................... 
INTRODUCTION  1 
........................................... 
Labels and Labeling  2 
................................................ 
Misbranding  3 
.................................... 
False or Misleading Labeling  4 
..................................... 
GENERALDEVICE.L.A..B.E.L.IN..G. ......................................  5 
Introduction  5 
..................................... 
General Labeling Provisions  5 
.... 
Labeling Requirements for Over-the-counter  (Non-Prescription)  Devices  7 
....................... 
Exemptions from Ad.e.q.u.at.e. D.i.r.ec.t.io.n.s. f.o.r .U.s.e .........................  8 
Other Exemptions  9 
......................... 
Labeling Requirements for Specific Devices  10 
......................... 
IN VITRO DIAGNOSTIC PRODUCT LABELING  11 
................................................ 
Introduction  11 
..................... 
Label Requirements for the Immediate Container  11 
................. 
Labeling Requirements for Inserts and Outer Packaging  12 
........................... 
Exemptions from Labeling Requirements  14 
.......... 
Labeling of General Purpose Laboratory Reagents and Equipment  15 
................ 
LABELING FOR INVESTIGATIONAL AND 510(K) DEVICES  15 
................................................ 
Introduction  15 
........................... 
Premarket Notification [510(k)] Labeling  16 
................................ 
IDE Device Labeling Requirements  17 
.......... 
GOOD MANUFACTURING PRACTICE LABELING REQUIREMENTS  17 
................................................ 
Introduction  .............................  17 
General Device Labeling Requirements  20 
................. 
Additional Labeling Requi.r.em..e.n.ts. f.o.r .C.r.it.ic.a.l. D.e.v.ic.e.s. ..................  22 
Sterile Device Labeling  23 
......................................... 
Contract Sterilization  24 
........................... 
RADIATION-EMITTING  DEVICE LABELING  25 
................................................ 
Introduction  25 
................. 
General Labeling Requirements for Electronic Products  26 
.............................. 
Ionizing Radiation-Emitting. .P.ro.d.u.c.ts. ...............................  27 
Light-Emitting Products  28 
............................ 
Ultrasonic Radiation-Emitting  Products  34 
........... 
GOVERNMENT CONTRACT DEVICE LABELING REQUIREMENTS  35 
................................................ 
Introduction  ........................................  35 
Labeling Specifications  36 
.............................. 
DEVELOPMENT OF DEVICE LABELING  37 
................................................ 
Introduction  37 
............................................ 
Labeling Problems  ....................................  37 
Reducing Labeling Problems  .........  39 
Sample of Approval Form for Labeling. Advertising Literature.  Etc  43  INTRODUCTION 
The United States Food and Drug Administration develops and administers regulations 
under authority granted by  laws passed by  Congress that apply to food, drugs, cosmetics, 
biologics,  radiat~on-emitting electronic  products,  and  medical  devices.  Of  the  fourteen 
laws  currently  administered  by  FDA,  three  directly  address  the  labeling  of  medical 
devices: 
o  The Food, Drug, and Cosmetic (FD&C) Act - The FD&C Act applies to food, drugs, 
cosmetics,  biologics,  and  medical  devices.  Section  201  defines  the  terms  "label" 
and  "labeling"  as they  ap?  l y  to  medical  devices  and  draws a  distinction  between 
these  terms.  Section 502( )(I)  and  (2) requires  that  device labeling  bear  adequate 
directions  for  use,  operating  and  servicing  instructions,  and  either  adequate 
warnings  a Ba inst  dangerous  uses  to  health,  or  information  necessary  for  the 
protection o  users. 
o  The Fair Packaging and Labeling Act (FPLA) - Because medical devices had previously 
been  defined  and  regulated  by  the  FD&C  Act,  Section  5  of  the  subsequently 
implemented FPLA Act refers to and makes use of the terms "label" and "labeling." 
Requirements of the FPLA apply to over-the-counter medical devices distributed  by 
retail outlets. 
o  The Radiation Control for Health and Safety Act (RCHSA) - Section 358(h) of the 
RCHSA  requires  manufacturers  or  distributors  of  radiation-emitting  electronic 
products,  including  medical  devices,  to  place  certification  labeling  on  their 
devices. 
The specific requirements of  the above laws are implemented by  the  Secretary of  the 
Department of Health and Human Services (DHHS) in the form of regulations. Initially, FDA 
whlch is a part of DHHS, drafts proposed regulations. These proposed regulations are then 
submitted by the Commissioner of the FDA to the Office of Management and Budget. After the 
required  time frames for public comment have elapsed, these regulations are redrafted  or 
resubmitted,  and  may  eventually  result  in  finalized  labeling  regulations.  Final 
regulations are published in the FEDERAL REGISTER (FR) and have the force of law. 
Labeling regulations promulgated under the above Acts which pertain to medical devices 
are currently found  in  the following Parts of  Title 21  of  the Code of  Federal  Regulations 
(CFR). 
o  General Device Labeling - 2 1 CFR PART 801 
o  In Vitro Diagnostic Products  21 CFR PART 809 
- 
o  Investigational Device Exemptions - 2 1 CFR PART 8 12 
o  Good Manufacturing Practices - 2 1  CFR PART 820 
o  General Electronic Products  - 2 1  CFR PART 1010 
Each  of  these  parts  or  categories  will  be  covered  in  detail  in  following  sections  of 
this chapter;  however.  before  continuing,  a few  brief  concepts  and  definitions  from  each 
Act applicable to labeling are discussed. 
The FD&C Act is the primary law under which the FDA takes action against regulated 
products. Specifically: 
o  Sections 20 I (k) through 20 1 (m) of the FD&C Act address labeling "definitions. "  o  Sections within Chapter 111 of  the FD&C Act address prohibited acts with respect to 
food, druf  s, cosmetics, and medical devices. These prohibitions deal with two major 
areas: "a ulteration" and "misbranding."  
o  Sections within  Chapter  V  of  the  FD&C  Act  set  forth  specific instances whereby 
druC  s  or devices will be considered to be adulterated or misbranded by  the FDA.  The 
Ra  lation  Control  for  Health  and  Safety  Act  applies  both  to  medical  and  other 
radiation-emitting  electronic  devices.  Labeling  regulations  based  on  this  law 
pertain to FDA certification of electronic products and are found under 21 CFR Part 
10 10. 
The medical aspects of  the FPLA  apP l y  only  to  medical  devices intended for sale to 
consumers from retail outlets. This Act  re ers to many sections of the FD&C Act.  Labeling 
regulations based on the FPLA are found under 2 1 CFR Part 801. 
The RCHSA  applies both  to  medical  and  other  radiation-emittinf   electronic devices. 
Labeling regulations based  on  this law  pertain  to  FDA  certification o  electronic products 
and are found under 2 1 CFR Part 1010. 
LABELS AND LABELING 
Section  201  of  the  FD&C  Act  distinguishes  between  label  and  labelin t Certain 
provisions in  Chapter V of  the FD&C  Act  apply specifically to the  "label" of  t  e device, 
others are related to  its  "labeling." These terms are related, but  not  interchangeable. Of 
the  two,  the  term  "label" is  more  restricted.  Generally,  it  consists of  that  Ra rt  of  the 
display confined to  the device itself.  On  the other hand,  "labeling" deals wit  the label 
on the device, and descriptive and informational literature that accompanies the device. 
Section 201 (k) defines "label" as a: 
o  "display of  written, printed, or graphic matter upon the immediate container of any 
article.. ."  
The term  "immediate container" does not include package liners. Any word, statement, 
or other information appearing on the immediate contamer must also appear "on the outside 
container or wrapper,  lf  any  there be,  of  the retail  package  of  such  article, or  is  easily 
legible through the outside container or wrapper. " 
Section 20 1 (m) defines "labeling" as: 
o  "all labels and other written, printed, or graphic matter 
(1)  upon any article or any of its containers or wrappers, or 
(2)  accompanyind   such  article" at  any  time while a device is  held  for sale after 
shipment or  elivery for shipment in interstate commerce. 
The  term  "accompanying"  is  interpreted  liberally  to  mean  more  than  physical 
association with  the  product.  It  extends  to  posters,  tags,  pamphlets, circulars,  booklets, 
brochures,  instruction books,  direction  sheets, fillers, etc.  "Accompanying" also  includes 
labeling that  is brought together with  the  device after shipment or delivery for  shipment 
in interstate commerce.  Labeling and Advertising 
The distinction between  labeling and advertising, both  of  which draw attention to the 
article to be  sold, is often superfic~alo r nebulous.  Both  are used  for a similar purpose, 
i.e.? to  provide  information  about  the  product.  Thus,  according  to  an  appellate  court 
decision:  "Most,  if  not  all  advertising,  is  labeling.  The  term  'labelint'  is  defined  in 
the FD&C Act  as including all printed matter accompanyint   any article.  ongress did not, 
and we cannot, exclude from the definition printed matter w ich constitutes advertising." 
MISBRANDING 
Section 502 of the FD&C Act contains provisions on misbranding and false or misleading 
labeling.  Specific re 9u irements and  exemptions are contained in  regulations promulgated 
under  this Act  as wi 1 be  discussed in  forthcoming sections in  this chapter.  A device is 
misbranded if: 
o  Its labeling is false or misleading in any particular; 
o  It is in  packaB  e form and its label fails to contain the name and place of  business 
of  the  manu acturer,  packer,  or  distributor;  and  an  accurate  statement  of  the 
quantity of the contents in terms of weight, measure, or numerical count; 
o  Any required wording is not prominently displayed as compared with other wording on 
the device, or is not clearly stated; 
o  Its label  does not  bear adequate directions for use  including warnings against use 
in  certain pathological  conditions; or by  children where its use  maB   be dangerous 
to health; or against unsafe  dosage, or methods, or duration of  a ministration or 
application ; 
o  It is dangerous to health when used in the dosage or manner or with the frequency 
or duration prescribed, recommended or suggested in the labeling; or 
o  It does not comply with  the color additives provisions listed under  Section 706 of 
the Act. 
Sections 502 and 706 of the FD&C Act predate the medical device amendments and apply 
equally  to  food,  drug,  cosmetic,  veterinary  drugs,  and  biolo f ics.  The  Medical  Device 
Amendments of  1976 provided new authority for dealind  specifica ly with the misbranding of 
medical  devices.  These  additional  provisions  liste  below  state  under  what  further 
circumstances a device is misbranded. 
o  If  the  device's  established  name  (if  it  has  one),  its  name  in  an  official 
compendium, or any common or usual name is not prominently printed in type at least 
half as large as that used for any proprietary name; 
o  If  the  device  is  subject  to  a  performance  standard  and  it  does  not  bear  the 
labeling prescribed in that standard; 
o  If  there  is  a failure or refusal  to  comply  with  any  requirement F rescribed  under 
the FD&C Act, Section 5 18 on  notification and other remedies, or  ailure to furnish 
any  materials  or  information requested  by  or  under  Section  519 on  reports  and 
records; or  o  If  it  has  any  representation  that  creates  an  impression  of  official  approval 
because  of  the  possession  by  the  firm  of  an  FDA  registration  or  premarket 
notification number. 
FALSE OR MISLEADING LABELING 
Section  502(a) declares  that  a  drug  or  device  is  misbranded  if  its  labeling  proves 
false or misleading in any  particular. The phrase  "false or misleading" is not  confined in 
meaning  to  untrue,  forged,  fraudulent, or  deceg t ive.  In  fact,  the  word,  statement,  or 
illustration  may  be  true  in  the  strict  sense  of  t  e  word;  however,  the  labeling  can  be 
deemed by  the FDA to be in violation of the law if  it proves deceptive to the customer. It 
is not  a necessary condition that  the labeling  should be flatly and  baldly  false; the word 
"misleadin!"  in  the  Act  means  that  labeling  is  deceptive if  it  is  such  as  to  create  or 
lead to a  alse impression in the mind  of the reader. A "false im P ression" may  result not 
only  from  a  false or  deceptive statement, but  may  also  be  insti led  in  the  mind  of  the 
r 
purchaser  b  ambi 1u ity  or misdirection.  It  may  also be  caused  by  failure to  inform  the 
consumer o  facts t at are relevant  to those statements actually made.  In  other words, the 
label that  remains silent as to certain consequences may  be  as deceptive as  the label  that 
contains extravagant claims. 
A device can be misbranded by  making reference to a medical device registration, or a 
510(k) premarket  notification  number  assi  ned  by  FDA  in  response  to  a  firm's  filing 
requirements under the FD&C Act. Section tf 07.39 of 21 CFR, Misbranding by reference to 
establishment registration or registration number, and 807.97 of  2 1 cfr, misbranding by 
reference  to  premarket  notification, state that  the  assigned  numbers  do  not  constitute 
official  FDA  approval  of  the device.  Additionally, any  representation that  connotes  FDA 
approval  as  a  result  of  complying  with  the  devlce  regulations  is  misleading  and 
constitutes misbranding. 
Similiarly,  a  device  can  be  misbranded  by  reference  to  an  Investigational  Device 
Exemption (IDE) or Premarket Approval (PMA). Section 301 (I)  prohibits the use on labeling 
of  any  device,  or  in  any  advertising  relatin 1 to  such  device,  of  any  representation  or 
suggestion or  approval  of  an  application wit  respect  to  such  device  is  In  effect  under 
Section 5 15, IDE or Section 520(g), PMA. 
Examples of false representations are: 
o  incorrect, inadequate or incomplete identification; 
o  unsubstantiated claims of therapeutic value; 
o  inaccuracies concerning condition, state, treatment, size, shape or style; 
o  substitution of parts or material; and 
o  use  of  the  prefix  "U.S."  or  other  similar  indication  suggesting  Government  or 
Agency approval or endorsement of the product. 
Examples of misleading labeling include: 
o  ambiguity, half-truths, and trade puffery; 
o  expressions of opinion or subjective statements; and  o  failure  to  reveal  material  facts,  consequences  that  may  result  from  use,  or  the 
existence of difference of opinion. 
Examples of other objectionable labeling practices include: 
o  deceptive pictorial matter; 
o  misleading testimonials; 
o  misleading list of parts or components; and 
o  use of brand or trade names instead of  "established names." 
GENERAL DEVICE LABELING 
INTRODUCTION 
The general labeling re Bu irements for medical  devices are contained  in  21  CFR  Part 
801. These regulations speci y  the minimum requirements for all devices. Later sections in 
this  chapter  discuss  any  additional  requirements  needed  for  specific  categories  of 
devices. 
GENERAL LABELING PROVISIONS 
Name and Place of Business (801.1) 
o  The label of a device shall contain the name and place of business of manufacturer, 
packer, or distributor including the street address, city, state, and zip code. 
o  If  the  firm's  street  address  is  in  the  local  telephone  directory,  the  street 
address can be omitted. 
o  If  the firrn  listed  on  the  label  is  not  the manufacturer,  the  firrn  information must 
be  qualified  by  an  appropriate  statement  such  as,  "Manufactured  for ..."  or 
"Distributed by.. . . " 
Intended Use (801.4) 
o  If  a  packer,  distributor,  or  seller  intends  a  device  for  uses  other  than  those 
intended by the person from whom he received the device, these parties must furnish 
adequate labeling in accordance with the new intended use. 
o  If  a manufacturer knows or has information indicating that his device is to be used 
for  conditions  or  purposes  other  than  which  it  was  intended,  he  is  required  to 
provide adequate labeling in  accordance with  such other uses.  (An  example of this 
might  be  a  manufacturer of  dental  X-ray  equipment  who  is  routinely  selling  his 
product to podiatrists.) 
Adequate Directions (80 1.5) 
o  "Adequate directions for use"  means directions under which  the layman can  use a 
device safely and for the purposes intended. This includes: 
-  Statements of  all purposes for which and conditions under which the device can 
be used;  -  Quantity of  dose for each use and  usual  quantities for persons of  different  ages 
and physical conditions; 
-  Frequency of administration; 
-  Duration of application; 
-  Time of administration in relation to other factors; 
-  Route or method of application; and 
-  Any preparation necessary for use. 
False or Misleading Statements (801.6) 
o  A device is misbranded if  it  makes a false or misleading statement with  respect  to 
another device, drug, food, or cosmetic. 
Prominence of Statements (80 1.15) 
o  A word,  statement or other required information may lack the required  prominence 
and conspicuousness for the following reasons: 
-  If  it  fails  to  appear  on  the  part  or  panel  that  is  displayed  under  customary 
conditions of purchase; 
-  If  the  package  contains  sufficient  space  and  the  required  information  fails  to 
appear  on  two  or  more  panels,  each  of  which  is  designed  to  render  it  to  be 
d~splayedu nder customary conditions of purchase; 
-  Failure to extend required labeling over package space provided; 
-  Lack  of  sufficient  label  space  for  required  labeling  due  to  placement  of  non- 
required labeling on the package; or 
-  Smallness or  style  of  type,  insufficient  contrast  between  labeling  and  package 
background,  designs which  obscure  labeling,  or overcrowding of  labeling which 
renders it unreadable. 
o  Exemptions may be granted in  those instances where device labeling lacks sufficient 
space for required labeling provided that: 
-  Existing label space is not taken  up by  includin % non-required information or by 
giving prominence to a portion of the required la eling; and 
-  Existing label space is not used for any representations in a foreign language. 
o  All  labeling  shall  be  in  English  with  the  exception  of  products  distributed  solely 
within Puerto Rico or a U.S. territory where the predominant Ian %u age is other than 
English.  In  these  instances  the  predominant  language  may  e  substituted  for 
English. 
P 
-  If  any  representation  on  the  device  label  or  labeling  a  pears  in  a  foreign 
language, then all required labeling shall also appear in that  oreign language.  LABELING REQUIREMENTS FOR OVER-THE-COUNTER (NON-PRESCRIPTION) 
DEVICES 
Principal Display Pane1 (80 1.60) 
o  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. 
Statement of Identity (80 1.61) 
o  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  t  pe,  reasonably  related  in  size  to  the  most 
prominent  printed  matter on  the isplay !an el, and  must  be  in  lines generally 
parallel to the base of the package on whic  it rests. 
Net Quantity of Contents Statement (80 1.62) 
o  The label of an over-the-counter (OTC) device in i' ackage form must contain a state- 
ment of net quantity of contents in terms of weig  t, measure, numerical count; or a 
combination of  numerical count and weight, measure, or size, which are described 
below: 
-  Count - If  the declaration by  count does not give accurate information as to the 
quantity, it shall be augmented by statements of weight, measure, or size; 
Measure  In cases of established customer usage and trade custom where units of 
-  - 
linear  measure  or  measure  of  area  are  used,  they  shall  be  augmented  when 
necessary  with  statements of  weight  measure or  size.  Liquid  measure is  to  be 
expressed in terms of the U.S.  gallon of  23 1  cu. in. and quart, pint,  and fluid 
ounce subdivisions, and shall express the volume at 68 degrees Farenheit; and 
-  Weight - Terms of weight are to be expressed in avoirdupois  ound and ounce. 
Units of metric weight or measure are considered su P plemen .t! a The declaration 
may contain common or decimal fractions. Common  ractions shall be reduced to 
the~rlo west terms.  -  Placement  - The declaration  shall appear as  a separate item on  each  principal 
display panel;  and  be  separated by  at  least a space equal to the height  of  the 
lettering  used  in  the  declaration, from  other information  appearinB   above  and 
below, and separated by  at least twice the width of  the letter "N"  rom  labeling 
to the left or nght. 
o  The  height,  ratio,  and  placement  of  letterin f  required  on  the  principal  display 
panel  are  a  function  of  a  number  of  variab es  related  to  package  slze,  shape, 
composition, and the method of  affixing the required labeling. This is described in 
deta~lu nder 2 1  CFR 80 1 .62 (g) to (k). 
EXEMPTIONS FROM ADEQUATE DIRECTIONS FOR USE 
Prescription Device (80 1.109) 
0 A device which,  because of  any  potentiality for harmful  effect, or the supervision 
of  the  method  of  its  use,  or  the  collateral  measures  necessary  to  its  use  is  not 
safe unless  under  a  practitioner  licensed  by  law  to  direct  use  of  this  device,  and 
hence for which  "adequate directions for  use"  cannot be written,  is exempt from 
such provided: 
-  It  is  in  the  possession  of  either  a  licensed  practitioner  or  persons  lawfully 
engaged in the manufacture or distribution of the product; 
-  Its  labeling  bears  an  Rx statement,  i.e.,  "Caution:  Federal  law  restricts  this 
device to  sale by  or on  the order of  a  (insert name of  physician,  dentist, 
or other licensed ~ractitioner)  :"  
-  Its  labeling  bears  information  for  use  including,  indications,  effects,  routes, 
methods, and frequency and duration of  administration, and an  relevant hazards, 
contraindications,  side  effects,  and  precautions  under  whici  the  device  can 
safely be used; and 
-  All  labeling other than  labels and cartons bears the date of  issuance or date of 
the latest revision. 
Retail Exemption (80 1.1 10) 
o  A device which  is  delivered  to  the ultimate user  by  a licensed  practitioner  in  the 
course of  his practice or upon prescription are requlred only to bear the name and 
address  of  the  practitioner,  directions  for  use,  and  any  required  cautionary 
statements. 
Commonly Known Directions (80 1.1 16) 
o  A  device  is  exempt  from  adequate  directions  for  use  if  adequate  directions  for 
common uses are known to the ordinary individual. 
In Vitro Diagnostics (80 1.1 19) 
o  Are  exempt  from  adequate  directions  for  use  provided  that  they  meet  those 
requirements found in 809.10 (covered in the "In Vitro Diagnostic Product Labeling" 
section of this chapter).  Medical Devices Used in Manufacturing (80 1.122) 
o  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." 
Medical Devices Used in Teaching, Research, or Law Enforcement (801.125) 
o  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. 
Expiration of Exemptions (80 1.127) 
o  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. 
OTHER EXEMPTIONS 
Exemptions from Packaging and Labeling Requirements (80 1.150) 
o  In-process devices that  are being  transported  (in transit) from  one  manufacturing 
site to another are exempt if: 
-  The person who introduced the product into commerce is the owner of  the firm 
where the device is to be further processed. 
-  The person  introducing  the  product  into commerce is  not  the owner,  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 [801.150(e)], and  are  exempt  only  if  both  of  the  following 
are met: 
1)  There is in effect a written agreement between the two parties containing: 
names  and  addresses of  both  parties  which  is  signed  by  both  the 
1. 
person  authorizing  the  shipment  and  the  person  in  charge  of  the 
sterilization facility; 
ii.  instructions for maintaining records to assure total accountability; 
iii.  acknowledgment that the devices are nonsterile and being shipped for 
further processing; 
iv.  a  statement  detailing  the  sterilization  process,  sterilant  media, 
equipment, and quality assurance controls to be used; and  2)  Each  pallet,  carton,  or  other  designated  unit  is  conspicuously  marked  to 
indicate its nonsterile nature. 
This exemption  is  void  if  the  product  is  adulterated or  misbranded, or  if  a  copy  of 
the agreement IS not available for FDA inspection. 
LABELING REQUIREMENTS FOR SPECIFIC DEVICES 
Warning and Caution Statements (80 1.403) 
o  This  part  contains  recommended  or  suggested  wording  for  warning  and  caution 
statements for the following devices: 
-  Denture reliners, pads and cushions 
-  Denture repair kits 
-  Infrared generators (including heating pads) 
-  Insulin syringes 
-  Mechanical massagers and vibrators 
-  Steam or turkish bath 
-  Ultraviolet generators 
Use Related Statements (801.405 to 801.430 as listed below) 
o  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: 
-  Denture repair or refitting kits (80 1.405) 
Special labeling and directions are listed in this section 
-  Pessaries for intracervical and intrauterine use (80 1.408) 
This  section  specifies  that  stem  types  and  wing-tip  types  are  considered 
dangerous and thus automatically misbranded. Hollow tube types are permitted, 
but require a Rx legend. 
-  Impact resistant lenses in sunglasses and eye8 l asses (80 1.4 10) 
This  section  specifies  that  case  har ening  of  glass  lenses,  statistical 
testing  of  plastic  lenses,  "drop  ball"  testing,  and  documentation  of  these 
activities are required. 
-  Ozone emission levels (80 1.4 15) 
This  section  specifies that  ozone emission  is  restricted  to  levels  below  0.05 
parts  per  million  in  certain  devices, and  not  P emitted  at  all  for  use  in  any 
medical conditions for which there is no proof o  safety or efficacy. 
-  Chlorofluorocarbon propellants (80 1.4 1 7) 
This  section  specifies the  use  is  prohibited  except  for  use  in  contraceptive 
foams and certain metered drug dosage forms as detailed under 2 1  CFR 2.125. 
Special  labeling  is  required  on  devices  using  this  propellant  as  listed  under 
80 1.425.  -  Hearin 8. aids (80 1.420) 
Labe mg  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 recordkeeping requirements are contained in 80 1.42 1. 
-  Intrauterine contraceptives (80 1.427) 
Professional  and  patient  labeling  requirements  related  to  description, 
indications, precautions, and warnings are contained in this section. 
-  Menstrual tampons (80 1.430) 
This  section  contains  those  labeling  requirements  related  to  Toxic  Shock 
Syndrome (TSS) information, warnings, and advisories. 
IN VITRO DIAGNOSTIC PRODUCT LABELING 
INTRODUCTION 
In  vitro  diagnostic  products  (IVD's)  are  those  reagents,  instruments,  and  systems 
intended for use  in  diagnosis of  disease or other conditions,  including a determination  of 
the  state  of  health,  In  order  to  cure,  mitigate,  treat,  or  prevent  disease  or  its 
sequelae.  Such  products  are  intended  for  use  in  the  collection,  preparation,  and 
examination of  specimens taken  from  the human  body.  In  vitro diagnostic (IVD) labeling 
requirements  are located  in  21  CFR Part  809. Numbers appearing  in  parentheses next  to 
subject headings are the corresponding sections of  21  CFR. This section contains the basic 
requirements  for  label  and  labeling  (package  insert)  as  specified  in  the  labeling 
regulations for in vitro diagnostic products. 
Specific  information  on  the  development  and  drafting  of  labels  and  labeling  is 
contamed in the "Development of Device Labeling" section in this chapter. 
LABEL REQUIREMENTS FOR THE IMMEDIATE CONTAINER  [809.10(A)J  
The label for  IVD's  must  state the following information, except in  cases where it  is 
not  applicable.  In  addition,  all  information  must  appear  on  the  outside  container  or 
wrapper, or be easily legible through the outside container or wrapper. 
If  the  presence of  any  label  information will  interfere with  the  test,  the  information 
may appear on the outside wrapper or container instead of the label. 
If  the  immediate  containers  are  too  small,  or  otherwise  unable  to  bear  labels  with 
sufficient  space,  then  the  required  labeling  as  listed  below  annotated  with  an  asterisk 
(*) may appear on the outer container labeling only. 
Label requirements are as follows: 
o  The established and proprietary names of the product, e.g., cholestrolometers; 
* 
o  The intended use or uses, e.g., pregnancy detection, diabetes screening, etc.; 
* 
o  A  statement  of  warnings  or  precautions  for  users  listed  in  16  CFR  part  1500 
(hazardous substances) and any other warnings  appropriate to  user  hazards,  and  a 
statement "For In Vitro Diagnostic Use;"  o  Name and place of business of the manufacturer, packer, or distributor; 
o  Lot or control number traceable to the production history 
-  Multiple unit products must have traceability of the individual units; 
-  Instrument lot numbers must allow for traceability of subassemblies; and 
-  A multiple unit  product that requires use of  its com Fo nents as a system should 
have  the  same  lot  number,  or  other  suitable  uni orm  identification,  on  all 
units. 
* 
o  For Reagents: 
-  Established (common or usual) name; 
-  Quantity,  proportion,  or  concentration  of  all  active  ingredients:  e.&., mg., 
weight  per  un~tv olume, mg./dl etc., and  for reagents derived from  b~olog~cal 
materials the source and measure of its activity, e.g., bovine, I.U., etc.; 
-  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: 
i.  expiration date (date beyond which the product is not to be used); 
* 
ii.  statement of any visual indication of alteration; 
* 
iii.  instructions for a simple check to assure product usefulness; 
* 
-  The net quantity of contents. 
LABELING REQUIREMENTS FOR INSERTS AND OUTER PACKAGING  [809.10(B)] 
Labeling must contain in one place the following information in the FORMAT and ORDER 
listed  below,  except  where  information is  not  applicable, or as  specified in  a  standard 
for a particular product class. 
If  the device is a reagent  intended as a replacement  in a diagnostic system, labeling 
may  be  limited  to that  information necessary to  adequately identify  the  reagent  and  to 
describe its use in the system. 
If  the device is a multiple purpose instrument used  for diaf  nostic purposes, and  not 
committed  to  specific  diagnostic  procedures  or  systems,  labe ing  can  be  restricted  to 
those points annotated by an asterisk (*). 
* 
o  The proprietary and established product name; 
* 
o  The  intended  use  of  the  product  and  whether  it  is  a  qualitative  or  quantitative 
type of procedure, e. g., screening, physician's office, home use, etc. ;  o  Summary  and  explanation  of  the  test,  including  a  short  history  containing 
methodology and the special merits and limitations of the test; 
o  The chemical, physical, physiological, or biological principles of the procedure. 
o  For Reagents: 
-  The common  name, if  any, and  quantity, pro  ortion, or concentration or each 
reactive  ingredient; and  for  biological  materiar,  the  source and  measure of  its 
activity; 
-  Appropriate cautions or warnings listed in  16 CFR Part 1500; the statement: "For 
In  Vitro  Diagnostic Use;"  and any  other limiting statements appropriate to the 
intended use of the product; 
-  Adequate directions for reconstitution, mixing, dilution, etc.; 
-  Appropriate storage instructions; 
-  A statement of purification or treatment required for use; and 
-  Physical, biological, or chemical indications of instability or deterioration. 
* 
o  For Instruments: 
Use or function; 
Installation Fr ocedures and requirements; 
Principles o  operation; 
Performance characteristics and specifications; 
Operating instructions; 
Calibration procedures, including equipment andlor materials; 
Operational f recautions and limitations; 
Hazards; an 
Service and maintenance information. 
o  Specimen collection and preparation for analysis, describing: 
-  Special precautions/preparations; 
-  Additives necessary to maintain specimen integrity; 
-  Known interfering substances; and 
-  Recommended specimen storage, handling, and shipping instructions. 
o  A step by step outline of recommended procedures from the reception of the specimen 
to  the  obtaining of  results.  In  addition  to  the  following,  this  should  include  a 
list of any points that might improve precision or accuracy: 
-  A list of  materials provided and  instruction for use,  e.g.,  reagents,  equipment, 
etc.; 
-  A  list  of  necessary  materials  that  are  not  provided  (include  details  such  as 
sizes, numbers, types, and quality); 
-  A description of the amounts of  reagents necessary, and parameters such as time, 
temperature, etc. ;  -  A  statement  related  to  final  reaction  stability  and  any  time  restrictions  on 
accurate measurements; 
-  Details of calibration, identifying and  listing any  necessary  preparation  of  the 
reference  materials,  samples,  and  blanks.  Describe  the  calibration  range 
including the highest and lowest values measured; and 
-  Details  of  necessary  quality  control  procedures  and  materials,  e. g.,  positive 
and negative controls, acceptable performance limits. 
o  Explanation of  the procedure for calculating the unknown, including the definition 
of  each  component  of  the  formula,  a  sample  calculation,  and  the  number  of 
significant figures appropriate for the answer; 
o  Limitations of  the  procedure, e.g., identify  situations which  will  have  an  adverse 
impact on test results; 
o  Expected values including the range and how it was established; 
o  Specific  performance  characteristics  as  appropriate  including  accuracy,  specifi- 
city, precision, and sensitivity; 
* 
o  Bibliography; 
* 
o  Name and place of business of the manufacturer, packer, or distributor; and 
* 
o  Date of issuance of the last labeling revision by the firm. 
EXEMPTIONS FROM LABELING REQUIREMENTS 
Shipments or  other  deliveries  of  IVD  devices  are  exempt  from  label  and  labeling 
re 9u irements in the above headings and from standards listed under Part  861 provided the 
fol owing conditions are met: 
o  A  shipment  or  delivery  for  an  investigation  subject  to  Part  812,  Investigational 
Device Exemption (IDE), if the device is in compliance with the subject IDE; or 
o  A shipment or delivery for an investigation that is not in compliance with Part 812 
gm  ost  IVD's  are  exempt from  the  IDE  because  of  the  following labeling) if  the 
ollowing conditions are met: 
-  A  product in  the laboratory research phase,  not  represented as an  IVD, that  is 
prominently labeled: "For Research  Use Only. Not for use in  diagnostic proce- 
dures;" and 
-  A  product  that  is  being  shipped  or  delivered  for  product  testing  prior  to  full 
commercial marketing that is prominently labeled: "For lnvestigationai Use Only. 
The performance characteristics of this product have not been established. 
"  LABELING OF GENERAL PURPOSE LABORATORY REAGENTS AND EQUIPMENT 
General  purpose  items  include routine  laboratory  reagents  such  as  hydrochloric acid 
and equipment such as glassware whose uses are generally known by  persons trained in their 
use. They do not need  to bear the directions for use  listed under Label Requirements for 
the Immediate Container and Labeling Requirements for Inserts and Outer Packaging, if 
their  labeling meets the requirements listed below.  If the product  packa !in  f is too  small 
to  accommodate  a  label  with  sufticient  space  for  the  labeling,  and  i  t  e  product  is 
packaged  in  an  outer container which  has  all  of  the  following on  its labeling, then  only 
those portions annotated with an asterisk (*) must be on the product label. 
o  Reagents: 
*  -  The proprietary and established name; 
-  A  declaration  of  the  established  name,  if  any,  and  quantity,  proportion.  or 
concentration of  the reagent  ingredient stated in  a system  generally  recognized 
by the user; 
-  A  statement of  the  purity  and  quality including  a qualitative statement  of  any 
impurities.  This  can  be  satisfied  by  using  a  statement  of  conformity  with  a 
generally recognized and available standard; 
-  A statement of  warnings or precautions for users as contained in the regulations 
in  16 CFR Part  1500 and any other appropriate warnings. and the statement: "For 
Laboratory Use; " 
-  Net  quantity of  contents in  terms of  weight  or volume, or numerical  count, or 
any combination thereof; 
-  Appropriate storage instructions; 
* 
-  Name and place of business of the manufacturer, packer, or distributor; and 
* 
-  A lot or control number traceable to the manufacturing history of the product. 
o  Equipment 
Product  labeling  need  include  only  a  statement  adequately  describing  the 
- 
product.  its  composition,  and  physical  characteristics  if  necessary  for  its 
proper use. 
LABELING FOR INVESTIGATIONAL AND 5 10(K) DEVICES 
INTRODUCTION 
An  "investigational device"  is  a  device  that  is  the  object  of  a  clinical  investigation 
or research  involving  one or  more  human  subjects to  determine its  safety and  effective- 
ness.  This definition also includes  "transitional devices" which  are devices that  had  been 
previously  regulated  by  the  FDA  as  drugs  prior  to  the  passage  of  the  Medical  Device 
Amendments, for example, pregnancy test kits.  All  newly  registered  medical device establishments and  existin % medical  device firms 
introducing  new  or  significant18  modified  devices  must  notify  F  A  of  their  intent  to 
market  the  device  at  least  9  days  before  introducing  the  devices  into  commercial 
distribution.  This  is  done  via  a  510(k)  Premarket  Notification  submission  which  is 
required by  that corresponding section of  the FD&C Act.  The purpose of  this submission, 
which includes copies of  proposed device labeling, is so that FDA can determine whether or 
not  the  device  as  labeled  is  substantially  equivalent  to  one  that  was  in  commercial 
distribution  prior  to  May  28,  1976.  This  includes  Class  I,  11,  and  111  devices,  or  a 
device that was Rl aced onto the market after that date that was classified by  FDA  as Class 
I or Class 11. T e 510(k) process does not  require manufacturers to demonstrate that their 
devices are identical  to marketed devices; only  that  the devices and  their  labeled  uses  be 
substantially  equivalent  in  terms  of  safety  and  effectiveness.  Clinical  data  may  be 
re% u ired  before  FDA  can  determine whether  a device  is  substantially equivalent under  a 
51 (k). 
If  a device  is  found  by  the  FDA  to  be  not  substantiall  e uivalent  and 
Class  111,  the  firm  must  demonstrate  proof  of  safety  andl e&cacr 
marketing. This demonstration is done via a Premarket Approval application 
must  contain  data  which  show  the  device  to  be  safe  and  effective.  An  approved 
Investigational Device  Exemption  (IDE) enables a device to  be  shipped to  researchers in 
order to collect data before the device is cleared by  FDA for commercial distribution. 
FDA  must  approve  IDE  applications for  significant risk  devices.  Non  si f nificant  risk 
devices are subject  only to  Institutional Review  Board  (IRB) approval.  The  DE  exempts 
. 
device  sponsors  and  investigators  from  certain  regulatory  requirements,  i e.,  those 
related  to:  performance  standards,  misbranding,  premarket  approval,  registration,  and 
, for  the  duration  of  the  study.  The  IDE  application  will  contain  an  investiga- 
tliiostninar   protocol  which  details  the  nature  of  the  study, and  the  nature  of  the  data  to  be 
obtained  and  furnished  to  FDA  as  proof  of  safety  and  efficacy.  The  sponsor  provides 
detailed  information on  device  labeling  in  the  investigational  plan.  This information  may 
vary depending on the device and the nature of the study, and can extend to such items as 
any advertisements placed in order to recruit human subjects for the investigation. 
PREMARKET NOTIFICATION [51  O(K)] LABELING 
There  is  no  application  form,  but  there  is  a  format  for  the  5 10(k)  submission 
contained in 2 1  CFR 807.81 to 807.97. Information required in the submission includes: a 
descric J 'tion  of  the device and  its  specifications, the class into which  the device has  been 
place  by  FDA, the firm's registrat~onn umber, a statement comparing the device to others 
of comparable type, and copies of  labeling and promotional literature. The proposed device 
labeling submitted in the 5 10(k) plays an important role. 
Labeling information to be included in a 5 10(k) submission may include: 
o  device labels; 
storage conditions; 
instruction manuals; 
o  service manuals; 
o  promotional literature such as advertisements, publications, etc. ; and 
o  other labeling requirements such as UL, F.C.C., etc.  If  the device labeling makes new, previously unsubstantiated claims or Pr omotes use of 
the  device  for  purposes or conditions other than  currently marketed  simi ar devices.  the 
FDA would most likely place the device into Class I11 and it would need premarket approval 
prior  to  marketing.  In  those  instances  where  a  device  is  substantially equivalent  to  an 
existing device,  or  technology  currently  in  use,  a  firm  should  attempt  to  obtain  510(k) 
clearance rather than  go for  premarket  approval.  The savings  in  time  and  cost  could  be 
considerable. 
IDE DEVICE LABELING REQUIREMENTS (21 CFR PART 812.5) 
If  a device is  found  by  the  FDA  to  be  not  substantially equivalent  and  placed  into 
Class 111, the firm must submit a PMA to FDA prior to marketing to demonstrate proof of 
safet  and  efficacy.  The  firm  must  first  apply  for  an  Investigational Device  Exemption 
(IDd to exempt them from certain regulatory requirements for the duration of  the study. 
The  IDE  appl~cationw  ill  contain  an  investigational fr otocol  which  details the  nature  of 
the  study, and the nature of  the data to  be  obtaine  and  furnished to  FDA  as  proof  of 
safety  and  efficacy.  The  firm  provides  detailed  information  on  device  labeling  in  the 
investigational protocol. This information may vary depending on the device and the nature 
of  the  study,  and  can  extend  to  such  items  as  any  advertisements Pl aced  in  order  to 
recruit  human  subjects  for  the  investigation.  For  example,  product  abeling  should  be 
sufficient  to  insure  stability  of  the  test  article  for  the  duration  of  the  study  (storage 
requirements,  recalibration  procedures), bear  sufficient  directions  for  proper  administra- 
tion,  alert  the  user  of  the  investigational  status  of  the  article,  and  detail  procedures 
to follow in the event of patient injury. 
In  addition  to  any  labeling  requirements  specified  in  the  IDE  study  protocol,  the 
following general labelmg is required: 
o  Information  required  in  801.1,  i.e.,  name  and  place  of  business  of  the  firm, 
quantity,  and  in  80 1.109,  the  following  statement:  "CAUTION:  Investigational 
Device. Limited by Federal (or United States) law to investigational use." 
o  A  description  of  all  relevant  contraindications,  hazards,  adverse  effects,  inter- 
fering substances or devices, warnings and precautions. 
o  Absence  of  any  statements  that  are  false  or  misleading,  or  that  represent  the 
device as safe and effective for its investigational purpose. 
o  Any device shipped solely for use on laboratory animals must be labeled: "CAUTION - 
Device  for  investigational  use  in  laboratory  animals  or  other  tests  that  do  not 
involve human subjects." 
GOOD MANUFACTURING PRACTICE LABELING REQUIREMENTS 
INTRODUCTION 
Medical device manufacturers must incorporate in their quality assurance (QA) pro  ram 
several  elements  that  relate to  labelind  in  order  to  meet  the  requirements  of  the  bMP 
regulation. The QA program must be a equate to assure that labeling meets the GMP device 
master  record  requirements  with  respect  to  legibility,  adhesion,  etc.,  and  assure  that 
labeling operations are controlled so that correct labeling is always issued and used.  Because many activities must be performed and controlled during the development and 
use  of  lahelinf  , Table 5.1  is  presented  as  a checklist.  It  contains a typical  sequence of 
events require  to develop and control labeling. 
Labeling  includes  equipment  labels,  control  labels,  package  labels,  directions  for 
use, maintenance manuals, etc. The displays on CRT's and other electronic message panels 
are  considered  labeling  if  instructions,  prompts,  cautions,  and  parameter  identification 
information are given. 
Various  sections  of  the  GMP  regulation  have  an  impact  on  labeling:  Section 
820.20(a)(2)  requires  approval  or  resection of  packaging  materials  and  labeling;  and 
Section  820.40  requires buildings  to  ke  of  suitable desi f n and  have  sufficient  space for 
packaging and  labeling operations.  Section  820.120 dea s with  specific requirements for 
the  design  and  control  of  labelin  It  ap! lie s  to  the  design  application  of  labeling  to 
assure legibility under  normal con  itions o  use  over the ex!  e cted  life of  the device; and 
%* 
also  to  inspection,  handling,  storage,  and  distribution  o  labeling.  FDA  considers  a 
device to  be  adulterated if  these  requirements  are  not  met.  These  requirements  do  not 
applT   to  the  adequacy  of  labeling  content, except  to  make  sure  the  content  meets  the 
labe lng  specifications contained in  the device master record.  However,  failure to  comply 
with  GMP requirements such  as  proofreading and  change control could result  in  labeling 
content errors.  In  such  cases, the device is  misbranded and  adulterated. Labeling content 
is covered in the section on  "Development of Labeling." 
Specifications are required in the device master record  (820.181, 182) for the content 
and  physical design parameters of  labels. Labeling  specifications are: engineering drawing 
andlor artwork  for each  label,  apf ) ropriate inspection  or control  procedures,  and  approp- 
riate procedures for attaching the  abels. All  procedures, drawings, and artwork must have 
the name of  the preparer, an aP  proval  signature, and a date. The approval signature, date, 
etc., may be on the backside o  artwork or on  a label approval form. Further, artwork may 
contain only  an  identification code or title  if  the  "content" of  the  artwork  is  duplicated 
on  approved engineering drawings or adequately identified (cross-referenced) with  respect 
to the label approval form. 
Hardcopy labels, package inserts.  and  similar labeling are specified and  Pu rchased  as 
components. For correct purchase and use  of  labeling, specificat~onsa re usua ly stated on 
engineering drawings andlor purchase  specifications. Thus, artwork or  "copy" alone will 
not  fulfill  the  device  master  record  requirements  for  labeling  except  or  the  most 
simplistic labeling such as brief errata sheets. 
The  engineering drawings  or  purchase  specifications and  mounting  procedure  must 
specify,  as  apR  ropriate,  the  label  substrate,  dimensions,  ink,  finish,  mounting  method, 
etc.,  so  that  t  e  purchased  label  will  remain  attached and  legible during  the  customary 
conditions of processing, storage, handling, distribution, and use. 
Front  panels,  other instrument panels,  meters, fuses,  pushbuttons,  and  the  like  often 
are labels or contain labels and must, as appropriate, meet GMP master record and control 
requirements. Component specifications, assembly drawings, and testlinspection procedures 
are appropriate GMP controls to prevent  mixup of  meters, pushbuttons, and  other labeled 
instrument  controls.  Controls to  prevent  mixups  are  generally  not  needed  for  front  and 
other instrument panels. 
Whether a firm considers a software driven display to be  labeling or data makes little 
difference under  the GMP regulation, because either way,  the finished device labeling or 
data must  meet  the device master  record  specifications. When  firms develop and  validate  TYPICAL SEQUENCE OF THE GMP CONTROL OF LABELS  (TABLE 5.1) 
GMP SECTION 
PHASE  DEVICE TYPE  (PART 820.)  CONTROL ACTIVITY 
1.  Development  NC*  C*  .I20 & Text review. Quality of mounting (rivets, 
adhesives, etc.). Quality of ink, anodize, 
etc. Content per 21 CFR 801, 807, 809, 
company claims and standards. 
2.  Evaluation  NC  C  Simulated or actual processing (e.g., 
Sterilization), shipping tests, etc. 
3.  Documentation  NC  C  Approve, date and change control label 
drawings. 
C  A key label must contain control number of 
finished device. 
4.  File Sample  C  Copy of actual label or artwork in the 
master record. See .I 8 1. 
5.  Procurement  NC  C  Proofread before release to inventory 
stock. 
Record signature of proofreader and date. 
6.  Storage  NC  C  Store labels so as to prevent mixups. 
C  Restrict access to labels to authorized 
persons. 
7.  Separate Operations  NC  C  Separate multiple operations to prevent 
mixups. 
8.  Area Inspection  NC  C  Before beginning labeling operations, 
designee to inspect area & remove 
extraneous devices & labels. 
9.  Issuance  NC  C  Examine for identity and. where 
appropriate, expiration date and control 
number. Record date and person examining 
labels. 
10. Inspection  Inspect finished device per written 
procedure. 
Designee must check all acceptance records 
& test results & see that records are 
present and complete. 
* 
NC  = Noncritical; C = Critical  software,  they  should  also  review  these  electronic  displays  to  see  that  the  "labelingt' 
meets  all  applicable  requirements,  such  as  adherence  to  specifications  in  the  master 
record,  correct  parameter  identification,  agreement  with  the  ~nstruction manual,  and,  of 
course, correct d~splayo f performance data. 
When  reviewing  or auditin g labeling operations, it  is  wise  to  keep  in  mind  that  the 
GMP  regulation  contains  flexi le  requirements  and  thus  allows  flexibility  in  a  quality 
assurance program.  The degree of  labeling control needed to  satisfy the  GMP regulation 
varies considerably for different devices and operations.  In  order to avoid wasting  money 
and  increasin  the  cost  of  health  care.  manufacturers  need  to  give  considerable  and 
prudent  thouf i  t  to the appropriate level  of  control needed for their operations as allowed 
by  820.5.  In ormation and guidelines presented in this chapter should aid manufacturers in 
making these decisions. The level of control needed should be reconsidered when  products 
are added  or changed.  Likewise, the  controls needed  and  success of  the  existing control 
program must be reviewed during QA system audits. 
GENERAL DEVICE LABELING REQUIREMENTS 
Label Integrity 
All  labels must  be  designed and  applied  to devices and  containers so that  the  labels 
will  remain  in  place  and  le% i ble during the customary conditions of  distribution,  storage. 
and  use.  Likew~se,o ther  la eling  such  as  user  instructions should  remain  legible  durmg 
customary storage and  use.  Note  that  820.120(a) which  states  "Labels shall be  designed, 
printed,  and  applied  so as to  remain  legible ..." refers  to  the  actual  design  of  the  label 
and mounting method--not just  testing or inspection of  these to show that  design  require- 
ments have been met.  [Inspection is covered by  the second sentence of  820.120(a). and by 
820.120(e), 820.20(a), 820.80 and 820.160.1 For example. labeling printed by machines onto 
plastic in vitro diagnostic media plates is sometimes smeared and thus is inadequate [FD&C 
502(f)]. The manufacturers of  such  devices must  assure that  the  print  is  legible and  will 
remain legible until used. 
Some magazines use  "wet" ink which smears when  touched by  sweaty or oily fingers. 
Obviously, thls type ink will  not  meet  the GMP design  requirements for package  inserts. 
instruction manuals, etc. 
Labels may  be mounted by  adhesives. screws, rivets. drive screws. etc.. or printed or 
etched onto panels andlor onto controls. The labels should be  located so that they will  be 
seen but  not  be  abraded during use.  (Some of  us  have  seen  the unbelievable cases where 
safety  labels  on  ladders  and  riding  lawnmowers  were  placed  in  the  foot  rest  areas.  Of 
course, they were scrubbed off after a few uses!) 
Receipt and Inspection 
Upon  receipt,  all  packaging  and  labeling  materials.  P reprinted  containers. 
inserts. and preprinted packaging materials must  be examinjnecdlu dainngd . i  deemed necessary by 
the  company.  tested  to  assure  conformance with  specifications.  Also.  samples  of  labels 
must  be  proofread  by  a  designated  individual(s). After  being  accepted  by  a  responsible 
individual.  these  components  may  be  placed  into  inventory  or  into  production.  These 
inspections  must  be  recorded  in  the  device  history  record  as  required  by  820.80(a) and 
820.120 to show that inspection and proofreading were performed. The inspection record for 
device labeling should be kept simple.  Area Separation and Inspection 
All  labeling  and  packaging  operations  should  be  separated  to  the  det i ree  necessary 
(820.5 and 820.40) to make certain there are no mixups between similar pro  ucts or labels. 
Separation  may  be  either  a  physical  or spatial separation  or  by  performing  the  labeling 
and  packaging  at  different  tlmes  for  different  devices.  Separation  is  not  required  when 
mixups are impossible such  as the case of  labeled front panels that  only  fit  the  intended 
family of instruments (devices). 
The likelihood of  a labeling mixup determines how  stringent production area controls 
should  be.  For  example,  label  control  need  not  be  stringent  if  only  dissimilar products 
and labeling are processed. Before beginning any packa?  i ng and labeling operation In which 
mixup could occur, the production area and equipment  or the operation must be thoroughly 
exammed to make certain that any devices and labeling materials remaining from  prevlous 
operations have been  removed.  It  is  important to make certain that  the surrounding area, 
tables,  packa f ing lines,  printing machines, and other equipment are cleared of  labels and 
other materia s used in the prevlous operation. 
Unused labeling that contains pre-coded serial numbers, manufacturing date, expiration 
date,  control  number,  etc.,  should  be  destroyed  and  not  returned  to  the  label  storage 
area.  The  GMP regulation  does  not  require  reconciliation  of  the  number  of  labels  used 
versus the number issued, although this control is recommended for some devices, such as 
when different sizes of the same product are being packaged or otherwise labeled. 
Storage 
All  printed  packaging  and  labeling materials,  including preprinted  containers,  inserts 
and  preprinted  packaging  materials,  must  be  stored  in  an  area  and  manner  suitable  to 
prevent  mixups  (820.40,  820.120).  Labeling  should  be  identified  and  segregated  to  the 
degree  necessary  to  prevent  mixing  of  similar  labeling.  Access  to  labeling  should  be 
limi ted to authorized personnel. 
Storage control should be appropriate for the number and kind of devices. For example, 
a  firm  that  manufactures only  one  product  with  one label  does  not  need  an  elaborately 
controlled  storage  area.  Similarly,  a  firm  with  only  a  few  types  of  devices  having 
dissimilar labeling would not normally require stringent control. 
One  case  that  requires  dedicated  attention  to  storage  and  control  is  prelabeled 
"sterile" but  "not-yet-sterilized" devices.  Firms must make absolutely certain that  mixups 
cannot occur.  Also make certain that all  such samples, if  used  for market  promotion.  are 
sterile  or  stamped  with  a  manifest  caution  statement  because  a  packaged  and  labeled 
market-  romotion  sample  might  be  used  by  the  recipient.  Quality  awareness training  is 
requirel by Section 820.25 and marketing personnel must be informed of  labeling control 
requirements and the consequences of a violation. 
Label Check and Record 
When issued for use, labeling must be carefully examined to make certain the contents 
of  the  labeling  comply  with  the  labeling  specifications in  the  device  master  record  for 
the specific device being produced. This examination must include any control numbers or 
expiration  dates  used  on  the  labels.  A record  of  this  issuance  check,  including the  date 
and name of  the person  performing the examination, must be  made in  the devlce history 
record.  If  used,  expiration dates must reflect the time after final  packaging during which  the 
device is fit for its intended use  when  stored and  used  per  its  labelrng. The manufacturer 
should  have  stability  test  data which  establishes the  interval  that  the  device  remains  fit 
for use. 
If  label mixups cannot occur--for example, a firm makes only one device or uses only 
one  label--and  there are no  control  numbers  or  exi  iration  dates,  the  original  inspection 
when  the labeling was placed into inventory is an  a equate check for compliance with the 
master record  specifications. A  second check need  not  be  performed  because it serves no 
purpose  (820.5).  If,  however,  there  is  any  possibility  that  incorrect  labeling  can  be 
used, a second check must be made when the labeling is issued for application, packaging, 
or shipping. 
Changes 
Labeling is  part  of  the device  master record; therefore, all changes to  labelin?   
be  made  under  a formal  change control system similar to  that  required  for speci icamtiounsst  
[820.100(a)(2)]. Any  changes to labeling must be formally reviewed and authorized before 
implementation. 
When making changes to primary aspects of a device and to primary documentation, the 
review  group  must  determine  if  any  secondarg   items  such  as  labels  or  instructions  are 
affected and also need changing. There should  e a check-off block on change-order forms 
for  recording  that  the  effect  of  the  primary  change  on  labeling  was  considered  and 
appropriate action was taken. 
Relabeling and Over-labeling 
Over-labeling by  placing a new  label over an  old  label is discouraged by  FDA  but  is 
acceptable as long as the new label and its use meet GMP requirements (820.120, 820.1 15) 
for  attachment,  legibility,  reprocessing,  and  change  control.  (Over-labeling  is  also 
discouraged in some foreign countries.) 
ADDITIONAL LABELING REQUIREMENTS FOR CRITICAL DEVICES 
Labeling  for  critical  devices  must  meet  the  noncritical  device labeling  requirements 
and meet the three additional requirements in 820.121 as covered below. 
Control Number 
Critical device  labeling  must  contain  a control  number,  serial  number,  letters, etc., 
for traceability. This means  a control number  for the  finished  device, and  not  the  label 
itself. Most  labeling, however, also contains another number, such as a drawing number, 
for control of labeling configuration and procurement. 
The control number for traceability need not  be on every label on the deviw; however, 
the control number must appear on  the unit label that goes to the ultimate user. The label 
on a shipping carton for bulk items does not meet this requirement because bulk items may 
o to  a central distribution point  in  the user-facility and  the shipping carton would  most 
ikely be  discarded.  In  order  to  meet  this  traceability  requirement,  a  label  that  would 
most likely reach the nurse or other user station must have the control number.  Proofreader's Signature 
Before  releasing  labeling  for  critical  devices to  invento ?' , samples of  labeling  must 
be  proofread  as  required  for  noncritical  devices.  In  ad  ition,  the  signature  of  the 
proofreader  and  the  date  of  the  proofreading  must  be  recorded  in  the  device  history 
record. 
Access Restriction 
Access to labeling must be  restricted to authorized personnel.  Labeling also should he 
stored in  an  adequately segregated area to minimize the chance of  mixups.  Although the 
access  re?  u irement  ap lies  to  labeling  for  critical  devices,  it  is  also  recommended  for 
labeling  or  noncritica!  devices  because  it  increases  the  control  over  the  label  storage 
area with no significant increase in cost. 
STERILE DEVICE LABELING 
Special attention  should be  given  to  the labeling of  sterile devices.  Devices  that  are 
not  sterile in  their entiretY   (for example,  sterility may  be  needed  only  for the  lumen  of 
certain devices) must be  abeled to properly  inform users what  is actually intended to be 
"sterile" in the package. For example, a possible limiting statement might be: 
"Caution: Only the fluid path of  the set is sterile and nonpyrogenic. Do  not use in  a 
sterile or aseptic area without proper precautions. " 
Some devices are intended to be  sterilized by  the  user  before use.  In  this  situation, 
the  labeling  should  provide  adequate  information as  to  at  least  one  suitable method  of 
sterilization and  any  precautions or safeguards to be  followed. For  example, the labeling 
should describe any: 
o  special cleaning methods required; 
r 
o  changes  in  the  ph  sical  characteristics  of  the  device  that  may  result  from 
reprocessing which a fect its safety, effectiveness, or performance; and 
o  limit  on  the  number  of  times  resterilization  and  reuse  can  be  done  without 
affecting the safety or effectiveness of the device. 
In  the  case  of  single-use  sterile  devices,  some  manufacturers  include  labelin  to 
advise  against  resterilization  and  reuse.  Some  devices  are  simply  not  designed  or 
constructed  to  be  recleaned,  and  may  not  be  capable  of  withstanding  the  necessary 
recleaning and  resterilization procedures. Where reuse is common  practice, manufacturers 
are encouraged to provide the mformation described in the above list. 
The  label  of  multi-device kits  or  packages  containing  a  comhination  of  sterile  and 
nonsterile products must not state or imply that all contents are sterile. 
The need  for users  to  have  instructions on  how  to  open  a sterile device package  to 
avoid  contamination of  the device also needs  to  be  evaluated, and when  necessary,  such 
instructions should be included in the labeling.  When a manufacturer modifies a device, the manufacturer must also review the labeling 
to  make  certain  that  it  reflects  current  revisions  and  specifications. Some manufacturers 
identiff "  labeling  with  a  drawing  number  plus  a  revision  code  or  date  as  an  aid  in 
identi ying  current  labeling. The package  insert  or other  labeling for  in  vitro  diagnostic 
products is required to contain the revision date [21 CFR 809.10(b)(lS)J. 
Shelf-life datin k  solely  for  packa  e  integrity  and  sterility  is  not  usually  re 1u ired 
by  FDA  for genera  medical  devices.  #here  may  be  a need  for expiration dating w en  a 
particular  component  of a  device,  such  as  a  battery  or  diagnostic reagent,  has  a  finite 
useful  life.  Labeling  for  in  vitro  diagnostic  devices  [809.10(a) and  (b)]  requires  an 
expiration date or some other means by  which users may  be assured of  quality at the time 
of  use.  This  requirement  applies  to  both  sterile  and  nonsterile  in  vitro  diagnostic 
devices. 
Althou f h not required by  regulation, most manufacturers of complex devices and sterile 
devices  vo untarild :  use  lot  or  serial  numbers  for  production  control  and,  if  the  need 
arises,  to  expe ite  failure  investigations,  repairs,  modifications,  or  recalls.  Lot, 
batch, or other control numbers are required for: 
o  critical devices (820.12 1); 
o  some products subject to radiological health standards; and 
o  in vitro diagnostic devices [809.1O  (a)(9)J. 
Adequate labeling for a medical device requires proper design and procurement of  the 
labels  and  labeling.  Design  includes  labeling  content that  meets  the  requirement  of  the 
GMP regulation as well as the needs of  the customer. To achieve these goals a number of 
concepts  must  be  kept  in  mind  such  as:  writing  to  the  reader,  referrmg  to  the  actual 
device in labeling, obvious identification of the controls used, etc. 
CONTRACT STERILIZATION 
Finished  devices that  are terminally sterilized by  a firm  other than  the  manufacturer 
pose a unique labeling problem. A common industry practice is to send the finished device 
In  its  final  packaging  to  a  contractor  for  sterilization.  The  final  packaging  is  labeled 
as sterile even  though  the  goods are unsterile during shipment from  the manufacturer  to 
the  contractor.  Specific  restrictions  apply  in  this  instance,  and  a  written  agreement 
between  the parties  must  be  in  effect  [820.150(e)]. The requirements for the labeling of 
in  process  sterile  goods  in  transit  to  the  contract  sterilizer are  addressed  in  detail  by 
Section 80 1.150, and covered previously under Other Exemptions in this booklet. Extreme 
care  must  be  taken  in  this  situation  to  eliminate  the  possibility  of  an  unsterilized 
product being mistaken  for a sterilized product.  A firm should seriously consider the use 
of  "visual  indicator"  labeling  to  distinguish  between  product  before  and  after  sterili- 
zation,  e.g.,  the  use  of indicator  tape with  bands  that  develop  color  upon  exposure  to 
steam or ethylene oxide, or stick-on "dots" which change color upon exposure to radiation. 
Bear  in  mind  that  visual  indicators  will  provide  confidence  that  the  product  has  been 
exposed  to  a  sterilant  and  not  that  the  product  is  sterile.  A firm should  also  consider 
the  use  of  dosimeters, i.e., a  product  that  undergoes  an  irreversible change in  physical 
or chemical properties that is proportional to the amount of  exposure to a sterilant. Some 
contract  sterilizers  affix  labeling  to  a  contractor's  product  in  the  form  of  a 
sterilization  number  stamped  upon  the  device  container,  or  outer  shipping  containers. 
Firms  who  use  the  contract  sterilizer's  lot  number  as  assurance that  their  devices  have 
undergone  sterilization  should  determine,  via  an  audit  of  the  facility  if  possible,  that 
sterilization lot numbers are applied after, not before, being subject to sterilization.  Regulations on distribution are contained in 21 CFR 801, Subparts A and E; and GMP 
Sections 820.150, 820.160 and 820.16 1.  Devices that have been sterilized. held. or ship ed 
to  the  manufacturer's  warehouse  or  other  controlled  distribution  point  before  &a1 
release  must  be  properly  labeled.  The  pallets,  or  designated  unit,  must  be  marked  to 
indicate  the  status  of  the  device  such  as  "sterilized:  awaiting  test  results,"  or  an 
equivalent statement. The company must  be able to show that it has control of  the devices 
until  final  release  and,  if  necessary,  could  have  them  destroyed  or  returned  for 
. 
reprocessind    For  this  reason,  a  distributor's  warehouse  or  facility  is  not  considered  a 
controlled  istribution point. 
RADIATION-EMITTING DEVICE LABELING 
INTRODUCTION 
Labeling of  radiation-emitting products applies to medical  devices; all  products which 
emit ionizing, or nonionizing electromagnetic or particulate radiation; and  products which 
emit  sonic,  infrasonic,  or  ultrasonic  radiation  as  the  result  of  operation  of  an 
electronic circuit.  Radiation-emitting devices  include  products  that  emit  radiation  either 
by  desi f n  (e.g.,  X-ray equipment) or as a consequence of  operation (e.g., television set), 
but  exc ude products that emit radiation  as a result of  the decay  of  a radioactive element 
or isotope (ed.   ., an  ionization type smoke detector). Section 358 of  the Radiation Control 
for Health an  Safety Act (RCHSA) of  1968 authorizes the development of Federal standards 
for these ty Pe s of  radiation producing  products.  These standards are contained within  the 
regulations  isted  under  2 1  CFR  Part  1000. The corresponding regulations are listed  by 
product  ty Pe   in  subse3 u ent  headings of  this  section.  This  booklet  will  cover  only  those 
R 
portions  o  these  stan  ards  related  to  product  labelin  and  will  not  attempt  to  address 
technical  specifications contained  in  the  standards.  T us,  the  nature  and  placement  of 
labeling may vary from those previously discussed under General Device Labeling; however, 
the concepts  of  "label" and  "labeling" remain  the  same,  e.g.,  the  "label" of  a  device 
might  consist  of  a warning  label  on  the  console  of  an  X-ray  system,  as  well  as  a  red 
indicator  light  on  the  panel:  the  "label"  of  a television  receiver  might  consist  not  only 
of  the name  of  the manufacturer.  date of  manufacture, and  user  caution  statements, but 
also of labels inside the receiver related to high voltages and X-ray shielding. 
At  the present  time, as a matter of  choice and  practicality,  FDA  does not  choose to 
actively regulate some common  household products  such  as  radios and  incandescent light 
bulbs; however,  if  such  products were found to  pose  a consumer hazard, the FDA  could 
choose  to  regulate  them.  A  good  example  of  a  hazard  to  consumers  is  the  cordless 
telephone.  As  a  result  of  consumer  complaints,  and  confirmed  injuries  due  to  the 
placement, volume, and frequencies of ringers in certain brands of  telephones, FDA set and 
enforced guidelines to prevent hearing injuries. 
This  section  will  cover  labeling  of  radiation-emitting  medical  and  other  electronic 
devices.  Due  to  the  amount  of  technical  data contained in  the corresponding sections of 
the  CFR,  reprints  of  the  CFR  sections pertaining  to  laser  labeling will  be  used  where 
appropriate to demonstrate format requirements. Numbers appearing in  parentheses next to 
subject headings are the corresponding sections of 21 CFR.  GENERAL LABELING REQUIREMENTS FOR ELECTRONIC PRODUCTS  ( 10 10.3) 
Manufacturers  of  electronic  products  covered  under  a  performance  standard  shall 
provide  the  followinf   information  on  a  tag  or label  permanently  affixed  or  inscribed  on 
the  product.  The  fo lowing  information  should  be  readily  viewable  when  the  product  is 
fully assembled: 
o  The full name and address of the manufacturer of the product. 
-  Alternately, the product can contain the full name and address of a compand ' or 
individual other than the manufacturer,  provided that the full name and ad  ress 
of  the  actual  manufacturer  has  been  previous1K    identified  to  the  Director  of 
the  Center  for  Devices  and  RadioloB  ical  Healt  (CDRH).  (This  alternative  is 
necessary  so  that  CDRH  can  identi y  manufacturers  of  particular  models  of 
devices  in  those  instances  where  the  listed  distributor  uses  different 
manufacturers for each model.) 
-  Abbreviations such  as  Co.,  Inc.,  or  their  foreign  equivalents,  and  the  initials 
of the first and middle names of individuals may be used. 
o  The place and month and year of manufacture. 
-  The place of manufacture may be expressed in a code if the code has  been 
previously supplied to the Director of CDRH. 
- 
The month and year of manufacture cannot be coded or abbreviated. The month and 
a four di 8i t number for the year must appear as follows: 
"MAN  FACTURED: (Insert Month and Year of Manufacture)" 
In  a  case  where  it  is  not  feasible to  affix  identification labeling  in  accordance  with 
the above,  the  Director  of  CDRH  may  approve  an application  for  an  alternate means  of 
identification. 
The  manufacturer  must  furnish the  Director of  CDRH  with  a complete  listing of  all 
brand  names  and  the  names  and  addresses  of  the  individuals or  companies  for  which 
electronic products are manufactured under a standard. 
Electronic products intended for United States Government use may be exempted from the 
above upon application to the Director of CDRH by the manufacturer, assembler, or a U.S. 
department or agency. 
All  products  intended  solely for export  shall  be  labeled or tagged  to  show that  they 
are intended for export. 
The manufacturer of any electronic product covered by an exemption from performance 
standards  (i.e.,  standards,  other  than  labeling,  which  are  not  covered  in  this  chapter) 
must permanently attach a tag or label stating: 
"This electronic product has been exempted from the Food and Drug Administration 
radiation safety performance standards prescribed in the Code of Federal Regulations, 
Title  21,  Chapter  I,  Subchapter J,  pursuant  to  Exemption  No.  , Granted  on 
- 
I1  IONIZING RADIATION-EMITTING PRODUCTS 
Television Receivers  (1020.1) 
A  television  receiver  is  an  electronic  product  designed  to  receive  and  display  a 
television  picture  through  broadcast,  cable,  or  closed  circuit  television.  Digital 
monitors which  display a fixed  (non-moving) image, e.g., computer screens, are excluded 
from the standard. 
o  Any  receiver  capable  of  producin8   radiation  in  excess  of  the  standard  through 
component  failure  or  improper  a ~ustment shall  have  a  permanently  affixed  or 
inscribed warning  label  llsting  the  high  voltage  specification and  instructions  for 
adjusting the high voltage to the specified value. 
Cold-cathode Gas Discharge Tubes  ( 1020.20) 
Cold-cathode discharge tubes are devices designed to demonstrate the effects of  a flow 
of electrons or the production of X-rays. 
o  Manufacturers  shall  provide  a  plicable  safety  instructions,  instructions  for  use, 
f' 
and power source specifications or each tube. 
-  Each  enclosure  or  tube  shall  have  permanently  affixed  polarity  identification 
of the terminals. 
-  Tubes desi  ned  for heat, fluorescence, or magnetic effect must have a warning 
8, 
indicating t  at excess power application may result in x-radiation. 
-  Tubes designed  for  x-radiation must  bear  a warning  that  the  device  produces 
X-rays when energized. 
o  The required tags or labels must be  visible when  the device is fully assembled for 
use. 
Diagnostic X-ray Systems  (10  20.30) 
Diagnostic  X-ray  systems  incorporate  one  or  more  certified  components.Certified 
components are X-ray system components manufactured after certain dates listed in 21 CFR 
1020.30(a)(i). Both  diagnostic  X-ray  systems  and  computed  tomography  X-ray  systems 
manufactured before November 29, 1984, are subject to the following requirements: 
o  The control panel containing the main power switch shall have a statement readin P : 
"WARNING: This X-ray unit may be dangerous to patient and operator unless sa e 
exposure factors and operating instructions are observed. " 
o  Temporarily  installed  compatible  components  must  bear  the  following  labeling: 
"Temporarily Installed Compatible Component. This certified component has been 
assembled,  installed,  adjusted,  and  tested  by  me  according  to  the  instructions 
provided  by  the  manufacturer.  Signature; Company  Name;  Street Address,  City, 
State, Zip Code, and Date of Installation."  o  Temporarily installed  noncompatible components must bear the following labeling: 
"Temporarily Installed Noncompatible Component. This certified component has been 
assembled or installed  by  me, but  could not  be  assembled, installed, adjusted, and 
tested  by  me  according to  the  instructions provided by  the  manufacturer  because 
other  already  existing  components  of  the  system  do  not  meet  the  compatibility 
specifications  of  the  certified  component  being  installed,  and  there  are  no 
conlmercially   available  certified components of a similar type that  are corn pati ble 
with the system. Signature, Company Name, Street Address, City, State, Zip Code, 
and Date of Installation." 
Radiographic Equipment  (10 20.3 1) 
o  If  the  device  has  the  capability of overriding the  positive  beam  limitation  (PBL) 
in case of  system failure, the override ke  or switch shall be labeled:  "FOR X-RAY 
." 
FIELD LIMITATION SYSTEM FAILU RL 
o  If  the  device  has  the  capability  of  overriding  the  automatic  X-ray  field  size 
adjustment  in  case of  s. f:s tem  failure,  the override switch  shall  be  labeled:  "FOR 
X-RAY FIELD LIMITA  ION SYSTEM FAILURE." 
Fluoroscopic Equipment  ( 1020.32) 
o  If  the  device  has  the  capability  of  overriding  the  automatic  X-ray  field  size 
adjustment  in  case of  system  failure,  the overnde  switch  shall  be  labeled:  "FOR 
X-RAY FIELD LIMITATION SYSTEM FAILURE. " 
Cabinet X-ray Systems  (1020.40) 
o  At  least one indicator shall be  visible from each door, access panel  and port,  and 
labeled: "X-RAY ON. " 
o  If  a cabinet X-ray system is designed to admit humans, it must bear the following 
additional labeling: 
- 
Any controls which can be used to initiate X-ray generation must be labeled: 
"CAUTION: X-RAYS PRODUCED WHEN ENERGIZED" 
- 
Each port shall have a clearly visible label stating: 
"CAUTION: DO NOT INSERT ANY PART OF THE BODY WHEN 
SYSTEM IS ENERGIZED - X-RAY HAZARD. " 
LIGHT-EMITTING PRODUCTS 
Lasers ( 10  40.1 0) 
Lasers  are  devices  capable  of  producing  intense  radiation  at  a  specific  wavelength 
both for medical and industrial purposes.  In addition to the general labeling requirements 
for  firm  name,  street  address,  state,  and  zip  code,  lasers  require  labeling  specific  to 
their  type,  class, wavelength,  and  power  output.  Due  to  the  numerous combinations  of  labeling types dictated by  class, wavelen th,  and power output, it would  not be practical 
to cover each  in  specific detail  in  this %ooklet. Instead.  use  the  following  sample  label 
types  in  conjunction with  the  following reprints  of  CFR sections  to  demonstrate specific 
-  - 
labeling requirements. 
SAMPLE LASER LABELS 
'I 
(  ) 
POSITION1 
IQD llcx LTTE.uG 
r POSITION 3 \  REPRINT SECTIONS OF 21  CFR  lO4O.lO(g) 
(g) Labeling requirements.  In addi-  (iii) Each  Class IIIb laser  produi 
tion to the requirements of  $$ 1010.2  shall have affixed a label bearing the 
and 1010.3, each laser product shall be  warning logotype B (Figure 2 of  para- 
subject to the applicable labeling re-  graph (g)(2)(ii)o f this section) and in- 
quirements of this paragraph.  cluding the following wording: 
(1) Class IIa and II designations and 
warnings.  (i) Each  Class  IIa  laser  [Position 1 on the logotypel 
product  shall  have  affixed  a  label 
"LASER  RADIATION-AVOID 
bearing the following wording: "Class 
DIRECT EXPOSURE TO BEAM"; 
IIa Laser Product-Avoid  Long-Term 
and. 
Viewing of Direct Laser Radiation." 
(ii) Each Class I1 laser product shall  [Position 3 on the logotypel 
have affixed a label bearing the warn- 
ing logotype A (Figure 1 in this para-  "CLASS IIIb LASER PRODUCT". 
graph)  and  including  the  following 
(3) Class IV designation and warn- 
wording: 
ing. Each Class IV laser product shall 
[Position I on the logotypel  have affixed a label bearing the warn- 
ing logotype B (Figure 2 of parazraph 
"LASER RADIATION-DO  NOT  (g)(2)(ii)o f this section), and including 
STARE INTO BEAM"; and  the following wording: 
[Position 3 on the logotypel  [Position 1 on the logotypel 
"CLASS I1 LASER PRODUCT".  "LASER  RADIATION-AVOID  EYE 
(2) Class IIIa and IIIb designations  OR SKIN EXPOSURE TO DIRECT 
and warnings. (i) Each Class IIIa laser  OR  SCATTERED  RADIATION"; 
product  with  an irradiance less than  and. 
or equal to 2.5~  W cmp shall have 
affixed  a  label  bearing  the  warning  [Position 3 on the logotypel 
logotype  A  (Figure  1 of  paragraph 
"CLASS IV LASER PRODUCT". 
(g)(l)(ii)o f  this section) and including 
the following wording:  (4) Radiation output information on 
warning logotype. Each Class 11. 111. 
[Position 1 on the logotypel 
and IV laser product shall state in ap- 
"LASER  RADIATION-DO  NOT  propriate units, at position 2 on the re- 
STARE INTO BEAM OR VIEW DI-  quired  warning  logotype,  the  maxi- 
RECTLY  WITH  OPTICAL  IN-  mum  output  of  laser  radiation,  the 
STRUMENTS"; and,  pulse duration when appropriate, and 
the  laser  medium  or  emitted 
[Position 3 on the logotypel  wavelength(s1. 
(5) Aperture label. Each laser prod- 
"CLASS IIIa LASER PRODUCT".  uct, except medical laser products and 
(ii) Each  Class  IIIa  laser  product  Class IIa laser products, shall have af- 
with  an  irradiance  greater  than  fixed, in close proximity to each aper- 
2.5x10-'  W cm-2 shall have affixed a  ture through which is emitted accessi- 
ble  laser  or  collateral  radiation  in 
label bearing the warning logotype B 
excess of the accessible emission limits 
(Figure 2  in this paragraph) and in- 
of  Class I and Table VI of  paragraph 
cluding the following wording: 
(dl of  this section. a label(s) bearing 
[Position 1 on the logotypel  the following wording as applicable. 
(1)  "AVOID EXPOSURE-Laser  ra- 
"LASER RADIATION-AVOID  diation is emitted from this aperture," 
DIRECT EYE EXPOSURE"; and,  if  the radiation emitted through such 
aperture is laser radiation. 
[Position 3 on the logotypel 
"CLASS IIIa LASER PRODUCT".  (ii) "AVOID  EXPOSURE-Hazard-  in Table VI. item 2 of paragraph (dl of 
ous electromagnetic radiation is emit-  this section. 
ted from this aperture."  if  the radi-  (7) Labels /or defeatably interlocked 
ation emitted through such aperture is  protective  housings.  For  each  laser 
collateral radiation described in Table  product.  labels shall be  provided for 
VI. item 1.  each  defeatably  interlocked  (as  de- 
Mi) "AVOID  EXPOSURE-Hazard-  scribed in paragraph (f)(2)(iv) of  this 
ous x-rays are emitted from this aper-  section)  portion  of  the  protective 
ture." If the radiation emitted through  housing which is designed  to be dis- 
such  aperture  Is  collateral  radiation  placed or removed  during operation. 
described in Table VI. item 2.  maintenance.  or  service,  and  which 
(6) Labels /or noninterlocked protec-  upon  interlock  defeat  could  permit 
tive housings. For each laser product.  human access to laser or collateral ra- 
labels shall be provided for each por-  diation in excess of the limits of Class 
tion of  the protective housing which  I or Table VI. Such labels shall be visi- 
has no safety interlock and which  is  ble on the product prior to and during 
designed  to be displaced or removed  interlock defeat and in close proximity 
during  operation.  maintenance.  or  to the opening created by the removal 
service.  and  thereby  could  permit  or displacement of such portion of the 
human access to laser or collateral ra-  protective housing.  and shall include 
diation in excess of the limits of Class  the wording: 
I and Table VI.  Such labels shall be  (1)  "CAUTION-Laser  radiation 
visible on the protective housing prior  when open and interlock defeated. DO 
to displacement  or removal  of  such  NOT STARE INTO BEAM."  for Class 
portion of  the protective housing and  I1 accessible laser radiation. 
visible on the product in close proximi-  (11)  "CAUTION-Laser  radiation 
ty to the opening created by removal  when open and interlock defeated. DO 
or displacement of such portion of the  NOT STARE INTO BEAM OR VIEW 
protective housing. and shall include  DIRECTLY  WITH  OPTICAL  IN- 
the wording:  STRUMENTS." for Class IIIa accessi- 
(1)  "CAUTION-Laser  radiation  ble laser radiation with an irradiance 
when open. DO NOT STARE INTO  less than or equal to 2.5x10+ W cm-l. 
BEAM."  for Class I1 accessible laser  (iii)  "DANGER-Laser  radiation 
radiation.  when  open  and  interlock  defeated. 
(ii)  "CAUTION-Laser  radiation  AVOID DIRECT EYE EXPOSURE." 
when open. DO  NOT STARE INTO  for Class IIIa accessible laser radiation 
BEAM OR VIEW DIRECTLY WITH  when  an  irradiance  greater  than 
OPTICAL INSTRUMENTS." for Class  2.5~10 -J W cm-l. 
IIIa accessible laser radiation with an  (iv)  "DANGER-Laser  radiation 
irradiance  less  than  or  equal  to  when  open  and  interlock  defeated. 
2.5l~o- ' W cm-?  AVOID  DIRECT  EXPOSURE  TO 
(111)  "DANGER-Laser  radiation  BEAM."  for Class IIIb accessible laser 
when  open.  AVOID  DIRECT  EYE  radiation. 
EXPOSURE." for Class IIIa accessible  tv)  "DANGER-Laser  radiation 
laser  radiation  with  an  irradiance  when  open  and  interlock  defeated. 
greater than 2.51~0 -'W cm''.  AVOID EYE OR SKIN EXPOSURE 
(iv)  "DANGER-Laser  radiation  TO DIRECT OR SCATTERED RADI- 
when  open. AVOID DIRECT EXPO-  ATION."  for ClaSIV accessible laser 
SURE TO BEAM."  for Class IIIb ac-  radiation. 
cessible laser radiation.  (vi) "CAUTION-Hazardous  electro- 
(v)  "DANGER-Laser  radiation  magnetic  radiation  when  open  and 
when  open.  AVOID  EYE OR  SKIN  interlock defeated." for collateral radi- 
ation in excess of  the accessible emis- 
EXPOSURE TO DIRECT OR SCAT- 
sion limits in Table VI. item 1 of para- 
TERED RADIATION."  for  Class IV 
accessible laser radiation.  graph (dl of this section. 
(vii) "CAUTION-Hazardous  x-rays 
tvi) "CAUTION-Hazardous  electro- 
when  open  and  interlock  defeated." 
magnetic  radiation  when- open."  for 
for collateral radiation in excess of the 
collateral radiation In excess of the ac- 
accesible emission limits in Table VI. 
cessible  emission llmits  in  Table  VI. 
item 1 of paragraph (d) of this section.  item 2 of Paragraph (dl of this section. 
(vli) "CAUTION-Hazardous  x-rays 
when open." for collateral radiation in 
exccss of the accessible emission limits  (8) Warning for visible and/or invis-  (ii) A statement of the magnitude, in 
ible radiation. On the labels specified  appropriate  units,  of  the  pulse 
in this paragraph, if  the laser or col-  durationsts). maximum radiant power 
lateral radiation referred to is:  and, where applicable.  the maximum 
(i) Invisible radiation, the word "in-  radiant energy per pulse of the acces- 
visible"  shall  appropriately  precede  sible laser radiation detectable in each 
the word "radiation"; or  direction in excess of  the accessible 
(ii) Visible  and  invisible  radiation,  emission limits in Table I of paragraph 
the  words  "visible  and  invisible"  or  (dl of  this section determined under 
"visible and/or invisible" shall appro-  paragraph (e) of this section. 
priately precede the word "radiation."  (iii) Legible reproductions (color op- 
(iii) Visible laser radiation only, the  tional) of  all labels and hazard warn- 
phrase "laser  light"  may replace the  ings required by paragraph (13) of this 
phrase "laser radiation."  section and 5 1040.11 to be affixed to 
(9) Positioning of  labels.  All labels  the laser product or provided with the 
affixed to a laser product shall be posi-  laser product, including the informa- 
tioned  so  as  to  make  unnecessary,  tion required for positions l. 2. and 3 
during  reading.  human  exposure  to  of the applicable logotype (Figure 1 of 
laser radiation in excess of the accessi-  paragraph (g)(l)(ii)o r Figure 2 or par- 
ble emission limits of Class I radiation  agraph (g)(2)(ii)o f  this section). The 
or the limits of collateral radiation es-  corresponding  position  of  each label 
tablished to Table VI of paragraph (dl  affixed to the product shall be indicat- 
of this section.  ed or. if  provided with the product, a 
( 10) Label spectfications. Labels re-  statement that such labels could not 
quired  by  this section  and  5 1040.11  be  affixed  to the product  but  were 
shall be permanently affixed to. or in-  supplied with the product and a state- 
scribed on, the laser product, legible.  ment  of  the  form  and  manner  in 
and clearly  visible during operation.  which they were supplied shall be pro- 
maintenance, or service, as appropri-  vided. 
ate. If  the size, configuration. design.  (iv) A listing of  all controls, adjust- 
or function of the laser product would  ments.  and procedures  for operation 
preclude compliance with the require-  and maintenance, including the warn- 
ments for any required label or would  ing "Caution-use  of  controls or ad- 
render the required wording of  such  justments  or  performance  of  proce- 
label inappropriate or ineffective, the  dures  other  than  those  specified 
Director. Office of Compliance (HFZ-  herein may result in hazardous radi: 
300). center for ~evicesandR adiolog-  ation exposure." 
ical Health, on the Director's own ini-  tv)  In  the  case  of  laser  products 
tiative or upon written application by  other than laser systems, a statment 
fhe manufacturer, may approve alter-  of  the compatibility requirements for 
nate means of  providing such label(s)  a laser energy source that will assure 
or alternate wording for such labelts)  compliance of  the laser product with 
as applicable.  this section and 5 1040.11. 
(h) Informational  requirements4 1)  tvi)  In  the case  of  laser  products 
User  information.  Manufacturers  of  classified with a 7 millimeter diameter 
laser products shall provide as an inte-  aperture  stop  as  provided  in  para- 
gral part of any user instruction or op-  graph (e)(3)(i) of  this section, if  the 
eration manual which is regularly sup-  use of  a 50 millimeter diameter aper- 
plied with the product, or, if  not so  ture  stop  would  result  in  a  higher 
supplied, shall cause to be  provided  clsssification of  the product. the fol- 
with each laser product:  lowing warning shall be  included  in 
(i) Adequate instructions for assem-  the  user  information:  "CAUTION- 
bly,  operation.  and  maintenance.  in-  The use  of  optical  instruments with 
cluding clear warnings concerning pre-  this product will increase eye hazard." 
cautions to avoid possible exposure to  (2) Purchasing and servicing infor- 
laser and collateral radiation in excess  mation. Manufacturers of  laser prod- 
of  the  accessible  emission  limits  in  ucts shall provide or cause to be pro- 
Tables I, 11-A. 11, 111-A.  111-B, and VI  vided: 
of paragraph (dl of  this section, and a  (i)  In  all  catalogs,  specification 
sheets. and descri~tiveb rochures Der- 
schedule of  maintenance necessary to 
taining to each laser product, a leg'ible 
keep the product in compliance with 
this section and 5 1040.11.  reproduction  (color optional)  of  the  class designation and warning required  (The information collection requirements 
by paragraph (13) of this section to be  contained in paragraph ta)(3)(ii) were ap- 
affixed to that product, including the  proved by the Office of  Management and 
information required for positions 1. 2.  Budget under control number 0910-0176) 
and  3  of  the  applicable  logotype  C50 FR 33688. Aug. 20. 1985; 50 FR 42156. 
(Figure  1 of  paragraph  (g)(l)(ii) or  Oct. 18,19851~ 
Figure 2 of paragraph (g)(2)(ii)o f this 
section).  E11040.11  Specific purpose laser products. 
(ii) To servicing dealers and distribu-  (a)  Medical  laser  products.  Each 
tors and to others upon request at a  medical  laser  product  shall  comply 
cost not to exceed the cost of prepara-  with all of the applicable requirements 
tion  and  distribution,  adequate  in-  of  P 1040.10 for laser products of  its 
structions for service adjustments and 
class.  In addition, the manufacturer 
service procedures for each laser prod- 
shall: 
uct  model,  including  clear  warnings 
(1) Incorporate in each Class I11 or 
and precautions to be taken to avoid 
IV medical laser product a means for 
possible exposure to laser and collater- 
the measurement of  the level of  that 
al radiation in excess of the accessible 
laser radiation intended for irradiation 
emission limits in Tables I.  11-A.  11. 
of  the human body. Such means may 
111-A.  111-B, and VI of paragraph (dl 
have an error in measurement of  no 
of this section. and a schedule of main- 
more than 20 percent when calibrated 
tenance necessary to keep the product 
in accordance with paragraph (a)(2) of 
in compliance  with  this section  and 
this section. Indication of  the meas- 
5 1040.11; and in all such service in- 
urement  shall  be  in  International 
structions, a listing of  those controls 
System  Units.  The  requirements  of 
and procedures that could be utilized 
this paragraph do not apply to any 
by persons other than the manufac- 
laser radiation that is all of the follow- 
turers or the manufacturer's agents to 
ing: 
increase accessible emission levels of 
radiation  and  a  clear  description  of  (i) Of a level less than the accessible 
the location of displaceable portions of  limits of Class IIIa; and 
the  protective  housing  that  could  (ii) Used for relative positioning of 
allow human access to laser or collat-  the human body; and 
eral radiation in excess of the accessi-  (iii) Not used for irradiation of  the 
ble emission limits in Tables I. 11-A. 11,  human eye for ophthalmic purposes. 
111-A. 111-B, and VI of  paragraph (dl  (2) Supply with each Class I11 or N 
of  this section. The instructions shall  medical  laser  product  instructions 
include protective procedures for serv-  specifying  a  procedure  and schedule 
ice  personnel  to  avoid  exposure  to  for  calibration  of  the  measurement 
levels of laser and collateral radiation  system required by paragraph ta)(l) of 
this section. 
known to be hazardous for each proce- 
(3) Affix to each medical laser prod- 
dure or sequence of  procedures to be 
uct, in close proximity  to each aper- 
accomplished,  and  legible  reproduc- 
ture through which is emitted accessi- 
tions  (color  optional)  of  required 
ble laser radiation in excess of the ac- 
labels and hazard warnings. 
cessible emission limits of  Class I, a 
(i) Modification  of  a certified prod- 
label bearing the wording: "Laser ap- 
uct. The modification of a laser prod- 
erture." 
uct,  previously  certified  under 
(b) Surveying,  leveling,  and align- 
4 1010.2, by any person engaged in the  ment laser products.  Each surveying. 
business  of  manufacturing,  assem-  leveling.  or  alignment  laser  product 
bling,  or  modifying  laser  products  shall comply with all of the applicable 
shall be construed as manufacturing  requirements of 1 1040.10 for a Class I, 
under the act if  the modification  af-  IIa, I1 or IIIa laser product and shall 
fects any aspect of  the product's per-  not permit human access to laser radi- 
formance or intended functionts) for  ation in excess of  the accessible emis- 
which this section and 4 1040.11 have  sion limits of Class IIIa. 
an applicable requirement. The manu-  (c)  Demonstration  laser  products. 
facturer who performs such modifica-  Each  demonstration  laser  product 
tion shall recertify and reidentify the  shall comply with all of the applicable 
product in accordance with the provi-  requirements of  1 1040.10 for a Class I, 
sions of $9 1010.2. and 1010.3.  IIa. 11. or IIIa laser product and shall 
not permit human access to laser radi- 
ation in excess of  the accessible emis- 
sion limits of Class I and, if applicable, 
Class IIa. Class 11, or Class IIIa. 
[50 FR 33702. Aug. 20. 19851  Sunlamp Products and Ultraviolet Lamps ( 1040.20) 
Lamps that produce ultraviolet radiation with wavelengths in air between 200 and 400 
nanometers which are desi %n ated as sunlamp products or ultraviolet lamps intended for use 
in sunlamp products are su ject to the requirements of  1040.20. 
All  labels  are to  be  affixed  or  inscribed  on  an  exterior  surface that  can  be  easily 
seen by the person being exposed immediately before use of the product. 
Sunlamp Products 
o  Each  sunlamp  product  shall  have  label(s)  with  the  warning  statement: 
"DANGER-Ultraviolet  radiation.  Avoid  overexposure.  As  with  natural  sunlight, 
overexposure  can  cause  eye  and  skin  injury  and  allergic  reactions.  Repeated 
exposure may  cause premature apin8   of  the skin and skin cancer. Wear Protective 
Eyewear; Fmlure to May Result In  evere Burns or Long Term Injury to the Eyes. 
Medications  or  cosmetics  may  increase  your  sensitivity  to  the  ultraviolet 
radiation. ConsultO  Fh ysician  before using sunlamp if  you  are using  medications or 
have  a  history  skin  problems  or  believe  yourself  especially  sensitive  to 
sunlight. If  you  do not  tan  in  the sun, you  are unlikely  to  tan  from  use  of  this 
product. " 
In addition the label must also contain: 
-  Recommended exposure positions; 
-  Directions for achieving the recommended exposure positions; 
-  A recommended exposure schedule; 
-  A statement  of  the  amount  of  time  it  may  take  for  the  expected  results  to 
appear; 
-  A designation of the ultraviolet lamp type to be used in the product; and 
-  Reproductions of  the required labeling are to be prominently displayed at  the 
beginning of the product instruction manual. 
Ultraviolet Lamps 
o  Labels for ultraviolet lamps require the following: 
-  The words: "Sunlamp - DANGER - Ultraviolet radiation. Follow instructions;" 
-  The model identification; and 
-  The words: "Use ONLY in fixtures equipped with a timer." 
ULTRASONIC RADIATION-EMITTING DEVICES 
Ultrasonic Therapy Products (1050.10) 
In  addition  to  the  general  labeling  requirements,  ultrasonic therapy  products  are 
subject to the following additional labeling requirements:  Operation controls--identification of operator control functions; 
Service  controls--identification  of  the  service  control  functions  plus  the 
statement "For sewice adjustment only; " 
Generators--generator  labels shall  state the  brand  name,  model  desi B nation,  serial 
number or other unique identification, ultrasonic frequency, and type o  waveform; 
Applicators--applicator labels  shall  state  the  brand  name,  model  designation,  and 
senal  number  or  other  unique  identification;  the  generator  for  which  the 
applicator  is  intended;  and  the  ultrasonic  frequency,  effective  radiating  area, 
maximum beam nonuniformity ratio, and type of applicator. 
Manuals--user instruction or operator manuals shall contain: 
-  assembly,  operation,  safe  use,  safety  procedures  and  precautions,  and  a 
maintenance schedule; 
-  description  of  the  s! e-ci al  distribution  of  the  ultrasonic  radiation  field  and 
the onentation of the  ield with respect to the applicator; 
-  description of  the  uncertainties in  magnitude of  various  parameters  relative to 
the ultrasonic energy; and 
-  a  listing  of  controls,  adjustments,  and  procedures  for  operation  and 
maintenance including a warning:  "Caution: Use  of  controls or adjustments or 
performance  of  procedures  other  than  those  specified  herein  may  result  in 
hazardous exposure to ultrasonic energy. " 
GOVERNMENT CONTRACT DEVICE LABELING REQUIREMENTS 
INTRODUCTION 
Agencies of the U.S. Government such as the Department of  Defense and the Veterans 
Administration are major purchasers, users, and warehousers of  medical  equipment.  Lar Re  
stockpiles  of  medical  equipment  are  maintained  in  warehouses  located  throughout  t e 
country.  In  addition to working stock drawn by  the military  services, reserves are needed 
to  maintain  a  state  of  war  preparedness.  Their  varied  needs  and  the  logistics  of 
distribution  necessitate  extraordinary  packaging  and  labeling  requirements.  For  example, 
supplies  of  hemostatic forceps must  be  readily  available for  immediate shipment,  or  use 
X 
after  prolonged  storage,  anywhere in  the world,  which  includes d  desert.  humid jungle 
environments,  or  sub-zero Arctic  conditions.  In  addition,  the  met  od  of  transport  could 
include droppirig from an airplane, or floating the supplies to shore. FDA requirements for 
labeling,  size,  and  placement  are  not  enough;  labelinB   must  be  appropriately  saltwater 
proof  and  fade resistant.  and may  even  include camou  age markings.  In  order to  assure 
conformity with  their  needs,  the  U.S.  Government  has  established military  standards,  or 
sP  e cifications,  for  about  every  imaginable  piece  of  equipment  including  hardware. 
e ectronics, and medical equipment.  LABELING SPECIFICATIONS MIL-STD-l 29H 
MIL-STD- 129H is the most commonly used labeling standard for U.S. Government medical 
equipment  purchases.  This  document  IS  generally  not  a  stand  alone  specification.  but 
rather  is  used  in  conjunction  with  the  device  specification.  For  example,  the  military 
specification  for  a  radiographic  grid  (known  as  #GG-G-00650a,  Grid,  Radiof  raphic, 
Strai B.h t,  Wafer TyB  e ) contains a heading entitled  "Labeling Specifications." The  abeling 
speci  cations  liste  call  for  Fed  Std  No.  123  (essentially  a  commercial  package)  for 
c~viliana gencies such as the General Services Administration, and requires MI L-STD- 129H 
for  the  military  services.  When  filling  a  Government  contract  these  specifications  take 
precedence over FDA requirements. 
The number,  size, placement,  and color of  the labeling would  be  specified in  the the 
product specification by referring to the appropriate section of MIL-STD-129H. 
The interior or unit  label  and  exterior  or  shelf  package label  requirements  contained 
in MIL-STD- 129H are as follows: 
NSNINATO stock number (National Serial Number)--a unique number assigned to a 
specific product type, regardless of manufacturer; 
Manufacturer's part number (when specifically required by the contract); 
Item description (as specified in the contract); 
Quantity and unit of issue; 
Contract, purchase, or delivery order number; and 
Level of protection and date preservation was applied. 
The outer packaging requirements are: 
NSNINATO stock number; 
Manufacturer's part number; 
Item description (as specified in the contract); 
Gross weight and volume in cubic feet; 
Level of protection and date preservation was applied; 
Proper shipping names (for hazardous items only); 
Contract, purchase order, or delivery order number; and 
Name. address, and zip code of prime contractor; 
LOGMARS* 
* 
On  7/1/82 the  Department  of  Defense had  amended  MIL-STD-129H  to  include  a 
requirement for LOGMARS (Lo istics AP  plication of Automated Markin C and Reading 
lg 
Symbolog6'  ) on device labels.  his labe ing is the same form as the U  C (Universal 
Product  ode) or bar  code which  has  become an  integral  part  of  consumer items. 
LOGMAR labeling includes a series of digitally encoded lines containing the NSN and 
contract number.  DEVELOPMENT OF DEVICE LABELING 
INTRODUCTION 
Labeling  is  very  important  to  medical  device  firms  because  there  is  often  a  direct 
relationship between  dev~cem  isuse  and  the  labeling, especially  in  the directions for  use. 
In  many  cases the labeling may  meet  the requirements of  the regulations; but  it  may  fail 
to  fully  take  into  consideration  the  user  needs,  possible  uses  other  than  that  indicated, 
or other factors that may contribute to misuse of the device. 
It is significant that aR  proximately 40% of  Mandatory Device Reporting (MDR) filings 
involve user error. FDA, t e medical device industry, and the users must become more aware 
of  this  situation and  work  together to  resolve  it.  One  of  the  problem  areas is  labeling. 
In  addition to  the cases where there is a primary association between  labelin g, and  MDR 
reports, labeling can also be  an  "underlying" or secondary cause of  misuse t at  leads to 
MDR reports. 
There are three general problem areas with labeling that FDA has encountered: 
Misbranding -  The failure of  the  labeling to  meet  the  rei ! uirements of  the  labeling 
regulations.  This  includes  misleading  statements,  inadequate  irections  for  use,  or  the 
exclusion of warning statements or contraindications; 
Poor Labeling Control - This situation occurs during the manufacturing process due to 
a  failure  in  the  quality  assurance  or  GMP  program.  Poor  labeling  controls  result  in 
incorrect  activities such  as  a  "mixup"  in  the  labeling  for  different  devices,  the  use  of 
outdated labeling, or the improper application of the labeling to the device; and 
Inadequate  Labeling  -  Labeling  that  does  not  constitute  misbranding  but  could  be 
improved to prevent misuse or mishandling of the device. 
The first  two  points,  misbranding,  and  poor  label  control  violate  the  letter of  the 
law. The last, inadequate labeling, or labeling that is less than it can or should be, may 
not  always violate  the  law,  but  can  result  in  problems  which  the  law  was  desi  ned  to 
prevent.  Previous  sections in  this  chapter have  addressed  two  aspects of  device fabeling 
necessary  to  comply  with  the  law.  The  first  section  in  this  chapter  discusses  the 
definition  and  causes  of  misbranding;  the  second  section  (Section  5)  discusses  areas  of 
poor  label  control  as  addressed in  the  medical  device GMP's.  This  section  will  address 
madequate labeling and  concentrate on  techniques for generating and  presenting text  that 
is  easy  to  read.  It  will  also  cover  how  to  correlate  text  with  figures,  and  how  to 
correlate text with the device. 
LABELING PROBLEMS 
Two of  the most  important aspects to  consider in  labeling devices is to he cognizant 
of  WHO will be using the device and HOW  it is to be used. Once this is realized, suitable 
labeling can be drafted. 
Often we  have heard stories of  parents unable to assemble "easy-to-assemble" toys on 
Christmas  eve.  Identical  products  with  identical  labeling  (the  instructions)  may  have 
other than  the same results after assembly.  Why?  Because the manufacturer had failed to 
consider WHO. The instructions had been written at the level of  someone moderately skilled 
in  mechanics, whereas some assemblers might be confused by  the operation of  an  electric 
drill. How could the problem be corrected? By the use of  labeling! A simple way would be  to  change the  labeling  to  read  "difficult-to-assemble;" however,  this  mif  ht  well  have  a 
negative  impact  on  sales.  The  proper  way,  as  we'll  cover  later,  woul  he  to  draft  a 
detailed  set  of  instructions,  using  pictorials  where  necessary,  directed  at  the  expected 
experience level of the purchaser. 
A manufacturer of aluminum porch awnin f s in  Florida had been  successfully marketing 
his  product  locally  for  over  20 years.  He  o tained  capital  and  expanded his 
along  the  Eastern  Seaboard.  Soon  he  began  to  receive  numerous  complaints 
collaR  se from the Northeast.  Why?  Because he  failed to  consider HOW.  The 
attac ment  recommended  in  the instructions was  insufficient to hold  the added weight  of 
predictable northeastern snowfall. In  a manner similar to  the above problem, the solution 
could  be  to  either  restrict  sales  to  states  below  in  the  Sunbelt,  or  to  provide  an 
explanation  and  a  ictorial  that  detailed  a  method  of  securing the  awning  properly  to 
support the expectec f additional weight. 
The same arguments hold  true  for medical  devices whether  they  be  catheters,  heart 
valves,  or  in  vitro  diagnostic products.  Labeling not  only  can  be  used  to  assure proper 
use of the device, but  can be used  to compensate for design deficiencies or alert the user 
to abnormal conditions. 
A  firm who marketed an  external ri  id  splint began  to  receive reports from  hospitals 
that  patients  had  suffered  bums  and  Elislering  on  limbs  where  the  splint  had  been 
applied.  The  splint  consists  of  a  coated  fabric  sandwiched between  polymeric  film  and 
foam.  In  use,  the foam  side is  placed  against the limb.  Water  is then  applied to initiate 
a chemical polymerization which releases heat and causes the splint to become rigid. 
The label on the s\ l int read: "Place Opposite Side on Limb." In one hospital personnel 
stated  that  the  label  ad  been  improperly  placed  on  the  limb  side  of  the  splint.  As  a 
result,  the  patients  limbs  were  burned  during  the  polymerization  reaction.  It  was  then 
discovered by  the firm  that some lots had  the label  on  the wrong  side of  the splint, and 
these lots were associated with the hospitals' complaints. 
In  fact, this  entire sequence of  events probably  could  have  been  avoided  by  proper 
label content. The phrase "Place Opposite Side on Limb" is an ambiguous statement and does 
not  identify  any  component  of  the  splint.  A  more  helpful  descriptive  statement  would 
state: 
"Place the (insert color, texture, etc.) Film on Outside, Away from Limb.  Caution: 
Film Gets Hot!' 
A  positive  statement  with  the  film  identified  by  color  or  texture  would  tend  to 
reinforce  the  instructions  for  proper  placement  of  the  label  during  manufacture,  and 
placement of the splint during use on the limb. 
Let's  take  another look  at  the  original  labeling on  the  splint:  "Place Opposite Side 
on  Limb."  Note the geometric term,  "side." In  general, be  very  careful when  using top, 
side,  end,  bottom,  edge,  and  other  geometric  terms  in  labeling  as  these  are  often 
ambiguous. Always make sure the intent is obvious when the user is looking at the device.  REDUCING LABELING PROBLEMS 
Adequate  labeling for a medical  device requires proper design of  labelin$, controlled 
procurement  of  the  labels  and  labeling,  and  proper  application  of  labeling.  Desil" 
includes labeling content that meets the requirement of  the GMP regulation as well as t  e 
needs of the user. One should emphasize the second point: needs of the user. To help meet 
the needs of  the  user,  there are some basic  f uidelines,  rules.  and  practices that  can  be 
used to immediately improve the writing of labe s and instructions. 
Writers are encouraged to obtain a copy of  40,000 Words or a similarly titled book by 
any of  the reference-book publishing companies. Most of  these reference books have about 
four  pages  of  punctuation  rules.  Using  the  four  small  pages  of  rules  can  immediately 
improve your writing. For example, you can avoid the common I ' unctuation error of not using 
semi-colons to replace commas when  needed. Also, one shou d obtain and use a standard 
college-level text on technical writing. 
Further, to  achieve our  goals  a number  of concepts must  be  kept  in  mind  such  as: 
writing  to  the  reader,  referring  to  the  actual  device  in  labeling,  obvious  identification 
of  the controls used, etc. Following is a review of  these points with emphasis on how they 
can be used to make labeling clear and comprehensible. 
Write to Reader 
The most  serious problem  is  that  writers  tend  to  write to  themselves.  Their material 
is  clear  to  them--and  they  mistakenly  think  it  is  as  clear  to  others.  For  example,  the 
sensitivity  control  on  an  instrument  is  called:  "gain"  control  on  page  one  of  the 
instruction manual,  "amplitude"  control  on  page  two,  and  "level"  control  in  the  next 
section.  Further,  the  photograph  in  the  Introduction  shows  the  same  control  with  a 
call-out labeled  "Signal Adjust".  No  wonder  readers are confused! Yet  the author of  the 
example knew  what  he was  trying to write about  and,  most  certainly, he was  writing  to 
himself. 
For  some  devices  such  as  home-use  devices,  it  may  be  necessary  to  determine  the 
reading level of the intended users. 
Refer to Actual Device 
One simple way  to reduce control  identity confusion as described above, reduce other 
types  of  labeling  errors,  and  increase  clarity  is  for  authors  to  keep  a  labeled 
instrument,  kit,  or  photograph(s) nearby  and  refer  to  it  as  they  write.  It  is  easier  to 
write the truth when you know the truth. Make sure the terminology and descriptions in the 
labeling matches  that  on  the  device.  Always  use  the  same title  for  each  given  item  or 
control  throughout  the  manual,  insert,  label,  or  advertisement.  Likewise,  the  same  title 
should  be  used  in  charts,  figures,  or  screen  displays  such  as  cathode-ray  tubes,  etc. 
Remember to: 
o  write to your intended readers; 
o  write with a labeled device or photographs in sight; and 
o  use consistent titles.  Obvious Identification of Controls 
Because  the title of  controls or other  items on  labels and  screen displays should be 
exactly the  same as in  the labels on  equipment, reagents, accessories, etc., authors may 
need  to  develop and  use  an  appropriate correlation technique for corresponding titles in 
instruction manuals, packa f e inserts, etc. One common technique is to use all capitals for 
the titles of controls in labe ing. For example: 
Flip the POWER switch to ON. 
Press the HEAT button to switch the heater on. 
In about three seconds, the READY lamp will illuminate. 
With  this  correlation  technique,  the  words  "on"  and  "off"  are  capitalized  in  the 
labeling only when they actually appear on the instrument control panel. Note that "ON" is 
capitalized in "POWER switch to ON" as the actual switch has "POWER", "ON", and "OFF" 
printed  by  it.  In  contrast,  note  that  "on" would  not  be  capitalized  in  the  example  "to 
switch  the heater on" as it  is not  a label of  a control on  the device. Also,  be  careful  to 
use  a  simple  correlation  system  for  names  of  controls  that  is  readily  apparent  to  the 
intended reader. 
4 
Don't Distract Reader 
a: 
Readers are very  busy  t  ing to learn  how  to  use  a new  device. They  should not  be 
annoyed by any unnecessary  ~stractionss uch as: 
o  changes in format; 
o  unusual typeface; 
o  incorrect Fa ge numbers, and 
o  incorrect  igure numbers. 
For  a  person  trying  to  read  in  a  hurry,  a  font  or  typestyle  that  the  author  may 
consider  to  be  routine,  such  as  script, can  be  a major  distract~on;t herefore,  don't  use 
script,  italics,  or  any  other  unusual  or  hard-to-read  typefaces.  Remember.  you  have 
dec~ded to  write  for  the  benefit  of  the  intended  user.  Forget  about  your  personal 
preferences  and  use  only  the  most  common  print  fonts.  Also,  select  a type  size that  is 
readable  at  the  intended  distance.  For  examf  le,  labeling  displayed  on  the  screen  of  a 
wall-mounted heart monitor must be readable  rom  several feet away. Also, use a consistent 
format  throughout  the  document.  Also,  check  the  format  and  section  titles  against 
information on  the contents page.  In some cases, such as for in vitro diagnostic products, 
the arrangement of information in the labeling may be dictated by regulation. 
Page numbers should not  be  referenced  in  instruction or  service manuals.  It  is  very 
easy for the actual page numbers to be  changed during the original writing  or when  the 
manual is updated. It is much  better to refer to  paragraph titles or para f raph numbers as 
they  are less likely to  change; and. if  changed, titles are more  noticeab e by  writers and 
typ~ststh an are page numbers. The use of correct figure numbers is easy--just check them. 
Short and to the Point 
It is imP  o rtant to use sentence structure that will  convey the intended message with  a 
minimum o  misinterpretation or need to reread. Tests have been conducted to determine the 
ability  of  readers to  follow instructions in  a  sentence based  on  the  number  of  activities 
to  be  performed.  The  average  person's  ability  to  follow  instructions  decreases  rapidly 
when  a  sentence contains more  than  two  facts.  (Keep in  mind  your  own  experiences in  reading instructions.) Therefore, sentences in  labeling need  to be  short and  to the point. 
Avoid  long  strin %s   of  adjectives  and  be  specific.  In  many  cases,  a  list  of  activitres  to 
be  performed is  etter than  buryin f  the facts in  long  sentences.  If  it  takes  lots of  words 
to  get  to  the point,  the reader wil  probably  miss the point! Short, choppy  sentences or 
lists  are  acceptable  in  instruction  manuals  and  other  labeling.  You  are  not  trying  to 
entertain  readers  with  beautiful,  flowing prose--rather,  you  want  to  "shock"  them  into 
remembering key facts until they correctly perform the specified instructions. Thus: 
o  use short sentences; 
iet  to the point; and 
o  e specific. 
Try  to  be  as  specific as  possible with  your  instructions.  For  example,  "ambient" or 
"room temperature" generally should not be used. Instead specify the desired or necessary 
range of operating conditions. 
Gobbledygook 
Another way to be more specific and shorten sentences is to avoid "gobbledygook." The 
following terms were collected from actual instruction manuals: 
ORIGINAL  EQUIVALENT 
* 
Makes provisions for 
* 
Serves to 
At the time of  When 
In conjunction with  And 
Carried out in  Perform 
Comes up to  Reaches 
Will also serve as a chance to  May 
Due to the fact that  Because 
Will be sure that will  Ensure 
* 
Available through the use of 
Care should be used so as not to  Be careful 
Be provided for positive determination 
Causes power to be applied to  Switches power to 
In  most  cases, the equivalent term  in  the list  can  replace the original term.  For  the 
asterisked items, the  equivalent  is  simply a direct statement of  what  intended. Of  the 
IS 
terms listed, the combination most often used is  "makes provision for." Simply eliminating 
"makes provision  for"  and  "be provided  for"  from  labeling will  result  in  an  immediate 
improvement for readers. 
Introduce Each Item 
Always  introduce each control, indicator, device, or subject before they  are discussed 
in  the text.  The introductions should be  brief  and  may  be very  brief.  Keep  in  mind  the 
items will be described in more detail later. Abbreviations and new or uncommon terms must 
be  defined.  The introductions and  definitions prevent  the reader from  goin 1 into mental 
shock, breaking  their train  of  thought, and  asking: What  is this?  By  then  t e reader has 
probably forgotten the last two or three facts read. Also, the reader may wonder about any 
"cliff-hanging" item  when  they  resume  reading.  This disturbance may  detract the person 
from  fully  assimilating  the  next  instructions  being  read.  To  avoid  distractions  and 
confusion, a writer of labeling should always:  o  introduce each item; and 
o  define new or uncommon terms. 
With  respect  to definitions, a writer should never  give  a new  meaning to an  existing 
term.  For example, quality assurance personnel of  medical device firms can no longer use 
the  word  "critical" in  their  routine  technical conversations because  "critical" was  given 
a  specialized definition  in  the  GMP  regulation.  To  avoid  this  disservice, coin  a  special 
term or code number such as Class C, Code 1, or Level 2. 
Accentuate Key Terms 
Whenever it is stated in instructions that something must be done, then  "must" should 
be  underlined,  set  in  bold  type,  or otherwise delineated.  Likewise,  caution and  warning 
statements  should  be  delineated  by  underlining,  boxing,  bold  type,  etc.  Refer  to  any 
regulations  or  standards  for  a  specific product  and  use  the  recommended  or  required 
caution statements. When  standard terminology exists, creating new  caution statements is 
not the best way for a writer to be creative. 
Select Words Wisely 
When  large  print  is  needed  for reading  at  a  distance or  to  attract  attention, signs, 
caution labels, screen prompts, and control labels generally must  be short in  order to fit 
the  available  space.  This  situation  places  a  burden  on  the  writer  to  select  terms  that 
convey the desired message. Consider the following wording from two actual highway signs: 
PLANT  TRAFFIC  NO FISHING 
ENTERING HIGHWAY  OFF BRIDGE 
Have you  ever been  run  over by  a  can't fish off the bridge, does 
that  mean  you  are  allowed  to  fish  on  bridge?  Better  choices for  the 
intended messages are: "Traffic entering  fishing from bridge. " 
Try Labeling 
Finally,  always  have  someone  not  familiar  with  the  product  operate  it  exactly 
r . 
according  to  the  draft  instructions and  screen  displays,  if  an  No  coaching--this  is  the 
"acid"  test--good  luck!  During  the  trials,  note  any  signi lcant  problems  and  make 
appropriate corrections to the instructions, prompts, or other labeling. You  may  also wish 
to  solicit  in?  u t  from  actual  users  of  the  product  with  respect  to  clarity,  reading  level, 
etc. The in ormation received  will  reflect  the  problems encountered by  persons tryinB   
follow the instructions without any preconceived knowledge of  the actual operation o  the 
product. 
Approval Policy and Procedure 
Before  release  for  use,  labeling  should  be  reviewed  and  approved  by  product 
develoP m  ent,  service,  marketing,  quality  assurance,  and  other  appropriate  managers. 
Manu acturers  need  to  have  a  policy/procedure  which  covers  the  draftmg,  review,  and 
approval of  labeling.  This procedure is  usually  used  with  an  approval form  such  as  the 
sample that follows. This form is intended for use by  a medium-to-large firm; however, the 
checklist  style  can  be  adapted  to  a  small  firm.  In  the  form,  the  areas  of  concern  are 
listed under the group that is responsible for that concern. Thus, every department in  the 
firm has input into the acceptability of the labeling.  APPROVAL FORM FOR LABELING, ADVERTISING, LITERATURE, Etc. 
Return to Approval Coord. after each signature or after checking any "no" box. 
Title  Document No.  DWG No. 
- 
Intended useldistribution 
Project Leadedtitle 
A  roval Coordinator 
Y E  NO  NIA*  E m  
'r 
Technical specs., installation data, &  art numbers are correct. 
Procedural information is accurate an  complete. 
Standards imposed by CSA, UL, IEC, etc. are met. 
Illustrations are technically accurate and final. 
Equipment protection cautions are included where necessary. 
Procedures have been checked on production model of the product. 
Changes requested in draft have been made or negotiated. 
Procedures are safe and effective. 
Final draft has been proofread. 
Proiect Engineer:  Date: 
j']  ~ ~ ~ r z v[I eAdpp roved with noted ch-Not  approved 
Engineering Services Mgr:  Date: 
[I Approved  [] Approved with noted c h a n g m o t  approved 
YES NO NIA  SERVICE 
[]  [j  [I  Maint./problem solving information is written for intended user. 
[I  []  [I  Lists part numbers needed to accomplish maintenance and repairs. 
Service Manager:  Date: 
[] Approved  [I Approved with noted cha-Not  approved 
YES NO NIA  TRAINING AND EDUCATION 
[I  [I  [I  Document is adequate for training purposes. 
1 J  11  11  Content of document agrees with experience of training 
specialists if experienced with this or similar product. 
Training Manager:  Date: 
(1 Approved  [I Approved with noted c h a n i N o t a pproved 
YES NO N/A  MARKETING 
e 
Material is effective and com  lete for intended use. 
Material meets the needs of t  e international market. 
Material is professional and projects the company image. 
All claims are substantiated by data on file in the company. 
Project Manager:  Date: 
[I Approved  [I Approved with noted c h a n i N o t  approved 
Director Marketing:  Date: 
I] Approved  [J Approved with noted c h a m N o t a pproved 
YES NO NIA  QUALITY ASSURANCE 
[j  [I  [I  All hazardous situations are highlighted with adequate warnings. 
1 1  [I  [I  All FDA requirements, GMP's are met. 
Quality Engineer:  Date: 
[J  Approved  [I Approved with noted c h a m n o t a pproved 
Drawing  number  is entered here and at upper righthand 
Corner by the Approval Coordinator  Date: 
N/A = not applicable  signature  FDA 86-4208  Medical Device Federal Register Documents (Revised June 1986) (PB 87-1154811 
AS, $13.95). 
FDA 86-4209  An Introduction to Transcutaneous Electrical Xerve Stimulation:  TENS (PB 87- 
107884/AS, $11 .95). 
FDA 86-4210  A Comprehensive Review of Hemodialysis Equipment and Related Peripheral Sup- 
port Equipment: Efficacy, Efficiency and Safety (Volumes I and 11) (PB 86-2454041 
AS, $28.95). 
FDA 86-4211    Hemodialysis Equipment and Practices in Massachusetts (PB 86-242427lAS, 
$11.95). 
FDA 86-4212  Protocol for the Study of Hemodialysis in Ohio (PB 86-245370/AS, $22.95). 
FDA 86-4213  State Participation in Dialysis System Investigation (PB 87-108825/AS, $24.95). 
FDA 87-4002  Impact Resistant Lenses:  Questions and Answers - June 1972 (FDA 81-4002) 
(Revised September 1987) (PB 88- 12302 lIAS, $12.95). 
FDA 87-4179  Device Good Manufacturing Practices Manual - Xovember 1985 (Revised November 
1987) (GPO 017-012-00330-3, $18.00) (PB 88-132139, $38.95). 
FDA 87-4188  Need Help With Medical Device Regulations?  Contact DSMA (supersedes FDA 84- 
4188) (pamphlet). 
FDA 87-4199  Medical Device Establishment Registration - Information and Instructions - May 
1987 (supersedes FDA 85-4199) (PB 88-123666/AS, $12.95). 
FDA 87-4214  Premarket Approval  (PMA  Manual (October 1986) (GPO 017-012-00329-0, $7.50) 
(PB 87-154365/AS, $18.95). 
FDA 87-42 15  Orthopaedic Device Labeling -- Guideposts for Concerned Physicians (January 1987) 
(flyer). 
FDA 87-4217  Proceedings of the First International Conference of Medical Devices Regulatory 
Authorities (ICMDRA) - June 2-6, 1986 (PB 88-123005/AS, $25.95). 
FDA 87-4218  Have a New Medical Device? (brochure). 
FDA 87-4219  Medical Devices Standards Activities Report (PB 88-123641/AS, $19.95). 
FDA 87-4221  Regulatory  Requirements for Devices for the Handicapped  (PB 88-123013/AS, 
$12.95). 
FDA 87-4222  An Introduction to Medical Device Regulations (pamphlet). 
FDA 87-4223  Classifying Your Medical Devices (brochure). 
FDA 87-4224  In Vitro Diagnostic Devices:  Guidance for the Preparation of 510(k) Submissions 
(GPO Ol7-Ol2-00331-l, $3.50) (PB 88-121801/AS, $14.95). 
FDA 88-4160  Import and Export -  Regulatory Requirements for Medical  Devices (August 
1988)(GPO0 17-012-00336-2, $2.25) (PB 89- l21859/AS, $13.95). 
FDA 88-4225  Review  and Summary of  Hemodialysis  System Investigative  Reports from 
California, the District of Columbia, Massachusetts and Ohio (PB 88-121793/AS, 
$19.95). 
FDA 88-4226  Medical  Device Reporting Questions and Answers (February 1988) (PB 88- 
192737/AS, $14.95). 
FDA 88-4227  Export of Medical Devices:  A Workshop Manual (September 1988) (GPO 017-012- 
00338-9, $10.00) (PB 89-119663/AS, $28.95). 
FDA 88-4228  Import of Medical Devices:  A Workshop Manual (September 1988) (GPO 017-012- 
00337-1, $8.50) (PB 89-1 l967l/AS, $21.95). 
FDA 88-4229  Applications of DNA Probes for the Diagnosis of Human Infectious Diseases:  An 
Overview (September 1988) (GPO 017 -012-00340-1, $2.00) (PB 89-120497/AS, 
$15.95). 
FDA 89-4158  Premarket Notification:  510(k) -  Regulatory Requirements for Medical Devices 
(November 1988) (GPO 017-012-00342-7, $3.75).  U.S. DEPARTMENT OF 
HEALTH AND HUMAN SERVICES 
Public Health Service 
Food and Drug Administration 
Center for Devices and Radiological Health 
Rockville, Maryland 20857