Medical Device Reporting
for User Facilities
                  
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration  Medical Device Reporting
for User Facilities
  
Prepared by
Office of Health and Industry Programs
Nancy Lowe, M.A. Consumer Safety Officer
Walter L. Scott, Ph.D. (CAPT. USPHS)
                  
April 1996
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Services
  Food and Drug Administration
Center for Devices and Radiological Health
Rockville, Maryland 20857 ii FOREWORD
The Center for Devices and Radiological Health (CDRH), part of the Food and Drug
Administration (FDA), develops and implements national programs and regulations 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 and radiation-
emitting devices.
The Center publishes the results of its work in scientific journals and in its own technical
reports.  Through these reports, CDRH also provides assistance to industry and to the medical
and health professional communities in complying with the laws and regulations mandated by
Congress.  The reports are sold by the Government Printing Office (GPO) and by the National
Technical Information Service (NTIS).   Many reports  are also available on the
Internet/World Wide Web.
We welcome your comments and requests for further information.
D. Bruce Burlington, M.D.
Director
Center for Devices and 
      Radiological Health
iii iv PREFACE
The Safe Medical Devices Act of 1990 (SMDA) imposed significant new reporting require-
ments on the medical device industry and users of medical devices.  SMDA requires user
facilities to report device-related deaths and serious injuries to the Food and Drug Administra-
tion (FDA) and/or the manufacturer.  Although the user facility reporting requirements of
SMDA were automatically effective November 28, 1991, this guidance document is based on
the final Medical Device Reporting (MDR) rule which was published in the December 11, 1995,
Federal Register.  The final rule also addresses changes mandated by the Medical Device
Amendments of 1992.
Much of the information in this document is general in nature and may not apply to a
specific situation.  Questions should be sent by facsimile (FAX) to (240) 276-3454 or mailed to:
Food and Drug Administration
Center for Devices and Radiological Health
Division of Surveillance Systems (HFZ-530)
Medical Device Reporting (MDR) Inquiries
1350 Piccard Drive
Rockville, MD 20850
Please include your name, return address, phone number, and (if applicable) FAX number with
your questions.
This guidance for user facilities is one of three documents written for a particular audience:
user facilities, manufacturers, and distributors.  All are available through the Internet/World
Wide Web at: http://www.fda.gov  and after June 1996, from the National Technical Informa-
tion Service, Springfield, Virginia 22161, telephone no. (703) 487-4650.  Other MDR docu-
ments are:
    Medical Device User Facility and Manufacturer Reporting, Certification and            
        Registration . . . Final Rules.  December 11, 1995,  Federal Register, pp. 63578-63607.
  Mandatory MedWatch FDA Form 3500A
  Instructions for Completing Form 3500A with Coding Manual for Form 3500A
  Abbreviated Instructions for FDA Form 3500A Specific to MDR
  MDR Semiannual Report Form FDA 3419
  MDR Baseline Report Form FDA 3417
  MDR Annual Certification Form FDA 3381
  Medical Device Reporting:  An Overview
  Medical Device Reporting for Distributors
  Medical Device Reporting for Manufacturers (draft)
  User Facility Reporting Bulletin  - all issues
Joseph A. Levitt
Interim Director
Office of Health and Industry Programs
v This guidance does not create or confer any rights, privileges or benefits for or
on any person, nor does it operate to bind FDA or any other person.  The
agency will consider individual circumstances on a case-by-case basis.  Where
this document reiterates a requirement imposed by statute or regulation, the
force and effect as law of the requirement is not changed in any way by virtue
of its inclusion in this document.   
vi CONTENTS
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v
1.  Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
Table 1 - Summary of MDR Reporting Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Table 2 - Summary of Other MDR Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
2.  User Facility Reporting Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Type of reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Individual adverse event reports  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Semiannual reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Individual adverse event report data elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Semiannual report data elements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
When to report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Information that reasonably suggests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Information that is reasonably known to user facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Requests for additional information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
When not to file . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Exemptions, variances, and alternative reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
English reporting requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Reporting codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Electronic reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Where to get forms and coding manual  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Where to submit reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
3.  Written Procedures, Record Keeping, and Public Disclosure . . . . . . . . . . . . . . . . . . . . . . . . . 7
Written procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Files . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Public availability of reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Disclaimers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
4.  Enforcement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Authority to Enforce MDR  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Criminal penalty authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Civil penalty authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
5.  Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Ambulatory surgical facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Becomes aware . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Caused or contributed to . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Device user facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Hospital  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Malfunction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
MDR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
MDR reportable event . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Medical personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Nursing home . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
vii Outpatient diagnostic facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Outpatient treatment facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Patient of the facility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Physicians office . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Serious injury . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Permanent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
User facility reporting number . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Work day . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
6.  Frequently asked questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Appendices 
A. FDA Form 3500A (mandatory MedWatch form)  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
B. Form FDA 3419 (MDR Semiannual Report)  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
C. Abbreviated Instructions for FDA Form 3500A Specific to MDR . . . . . . . . . . . . . . . . . 25
viii 1.  INTRODUCTION
In 1990, Congress enacted the Safe Medical Devices Act (SMDA) to increase the
information that the Food and Drug Administration (FDA) and manufacturers receive about
serious problems with medical devices.  Although manufacturers and importers of medical
devices have been required since 1984 to report to FDA all device-related deaths, serious
injuries, and certain malfunctions, numerous reports show widespread under reporting.  A 1986
General Accounting Office (GAO) study showed that hospitals reported less than one percent of
problems with medical devices and, the more serious the problem with a medical device, the less
likely it was to be reported.  A GAO follow-up study in 1989 concluded that despite full
implementation of the Medical Device Reporting (MDR) regulation, serious under reporting still
existed.
Under SMDA, device user facilities and manufacturers must report deaths and serious
injuries to which a device has or may have caused or contributed and must establish and
maintain adverse event files.  A device user facility is defined as a hospital, an ambulatory
surgical facility, a nursing home, an outpatient treatment facility, or an outpatient diagnostic
facility which is not a physicians office .  A medical device is any item that is used for the
diagnosis, treatment, or prevention of a disease, injury, or other condition and is  not a drug or
biologic.  (See sections 5 and 6 for definitions of terms and concepts.)  The user facility
reporting section of SMDA became effective on November 28, 1991.
To implement SMDA, FDA published a tentative final rule in the November 26, 1991,
Federal Register and invited comments on the regulation.  Over 300 comments were received. 
Then, on June 16, 1992, the President signed into law the Medical Device Amendments of 1992
(Public Law 102-300; the Amendments of 1992), amending certain provisions (section 519 of
the Food, Drug, and Cosmetic Act) relating to reporting of adverse events.  The primary impact
of the 1992 Amend-ments on user facility reporting was to establish a single reporting standard
for user facilities, manufacturers, and importers.  The final medical device reporting rule
published in the  December 11, 1995,  Federal Register addresses the comments received by
FDA and the changes mandated by the Amendments of 1992.  For easy reference, sections of
the MDR regulation are enclosed in brackets following terms and concepts. 
The following tables summarize the MDR requirements for user facilities and manufacturers. 
1 Table 1 - Summary of MDR Reporting Requirements
REPORTER REPORT WHAT? TO WHOM? WHEN?
User Facility Deaths FDA and  Within 10 work days
Manufacturer
Serious injuries* Manufacturer   Within 10 work days
FDA only if
manufacturer
unknown
Semiannual report of deaths FDA January 1 and  July 1
and serious injuries
Manufacturer 30-day reports of deaths, FDA 30 days from becoming aware
serious injuries* and
malfunctions
Baseline report to identify FDA With 30-day report  when 
and provide basic data on device is reported for first time
each device that is subject of
a 
report
5-day report on events that FDA Within 5 work days
require immediate remedial
action and other types of
events designated by FDA
Annual certification of FDA When firm submits annual
compliance with regulation registration
* Serious injury definition no longer necessitates immediate intervention, just medical or surgical intervention.
Table 2  -  Summary of Other MDR Requirements
REQUIREMENT APPLIES TO SUMMARY
Files User facilities and Records of complaints and MDR reports must be kept
manufacturers for a period of two years or, for manufacturers, the
expected life of the device, if longer.
Written MDR User facilities and Written procedures must be developed, maintained and
Procedures manufacturers implemented for (1) identification, evaluation, and
timely submission of MDR reports, and (2) compliance
with record keeping requirements.  
Exemptions, User facilities and Investigational devices are exempt.  Exemptions,
Variances and  manufacturers variances or alternatives to any or all of the reporting
Alternative  requirements may be granted upon request or at the
Reporting discretion of FDA.
Designation of Foreign manufacturers Foreign manufacturers must designate an agent in the
U.S. Agent U.S. who will register and submit MDR reports, conduct
or obtain information about investigations, forward 
reports to the manufacturer and maintain complaint files
on behalf of the manufacturer.
2 2.  USER FACILITY
REPORTING REQUIREMENTS
     User facilities must report deaths and serious injuries when they become aware of information
that reasonably suggests a medical device has or may have caused or contributed to the adverse
event.  They must also establish and maintain adverse event files.
2.1 Type of reports 2.2 Individual adverse event report data    
elements [803.32]
User facilities are required to file two
types of reports:  User facility reports (using FDA Form
3500A) must contain the following: 
Individual adverse event reports 
[803.30]  patient information (block A); 
Individual adverse event reports include  description of adverse event or product
reports of death and serious injury which are problem (block B); 
submitted on FDA Form 3500A or an
electronic equivalent.    suspect medical device information
(Block D); 
A user facility must report to the device
manufacturer and FDA whenever the facility  initial reporter information (Block E);
has information that reasonably suggests a and 
device has or may have caused or contributed
to a patients death.  If a facility has  user facility information (Block F)  
information that reasonably suggests a device
has or may have caused or contributed to a 2.3 Semiannual report data elements      
patients serious injury, it must report this [803.33]
information to the device manufacturer.  If
the manufacturer is not known, the report A semiannual report must contain the
should be sent to FDA. following information:
Semiannual reports  [803.33]  user facilitys Health Care Facility
Administration (HCFA) provider num-
If any individual adverse event report ber or number assigned by FDA; 
was submitted during the previous 6-month
reporting period, a user facility must submit a  reporting year and period, e.g., January
semiannual report to FDA on FDA Form through June or July through December; 
3419, or an approved electronic equivalent.
Semiannual reports are due by January 1 (for  facilitys name and complete address; 
reports made July through December) and by
July 1 (for reports made January through  total number of reports attached or
June) of each year.  summarized; 
A semiannual report should not be  date of the semiannual report and the
submitted if no individual reports were lowest and highest report numbers
submitted to FDA or manufacturers during submitted during the report period; e.g.,
the reporting period.  1234567890-1995-0001 through 1000; 
3  name, position title, and complete      Semiannual reports are due on January 1
address of the individual designated and July 1.
as the facility contact person
responsible for reporting to FDA, 2.5 Information that reasonably              
and whether or not that person is a suggests [803.20(c)]
new contact for that facility; and 
Information that reasonably suggests
 information for each reportable that a medical device has caused or
event that occurred during the contributed to a MDR reportable event (i.e., a
semiannual reporting period death or serious injury) includes any
including: information such as professional, scientific,
or medical facts and observations or opinions
- user facility report number; that a device has caused or may have caused
or contributed to a reportable event.
- name and address of the device
manufacturer; 2.6 Information that is reasonably
known to user facilities   [803.30].  
- device brand name and common
name;  User facilities must provide all
information that is reasonably known to them. 
- product model, catalog, serial, and This includes information found in
lot number;  documents in the possession of the user
facility and any
- a brief description of the event      information that becomes available as a
reported to the manufacturer result of reasonable follow-up within the
and/or facility.  A user facility is not required to
FDA; and evaluate or  investigate the event by obtaining
or evaluating information that is not
- where the report was submitted, reasonably known to it.
i.e., to FDA, manufacturer,
distributor, etc. 2.7 Requests for additional information      
 [803.15]
In lieu of submitting a summary of each
reported event, a user facility may complete FDA may determine that protection of
only Part 1 of FDA Form 3419 and attach a the public health requires additional or
copy of each mandatory report (FDA Form clarifying information for an MDR report.  In
3500A, or an approved electronic equivalent) these instances and when additional
filed during the reporting period. The copies information is beyond the scope of FDA
and envelope should be clearly identified as reporting forms, or is not readily accessible,
Semiannual Report.  the agency will notify the user facility of the
additional information that is required.  Any
2.4 When to report [803.20] request will state the reason or purpose for
which the information is being requested,
All individual reports of death and specify the date that the 
serious injury must be submitted within  10 information is to be submitted, and clearly
work days from the time that any medical relate the request to a reported event.  All
personnel of the facility becomes aware of a verbal requests will be confirmed in writing
reportable event.    by FDA.
4 2.8   When not to file  [803.22] alternative reporting media (magnetic tape,
disc, FAX, etc.)  and computer-to-computer
If a user facility becomes aware of communi-cation.  Any electronic report
information from multiple sources regarding meeting electronic reporting standards,
the same patient and same event, only one guidelines, or other procedures developed by
MDR report is required.  An MDR report is FDA for MDR, will be deemed to have prior
not required if the user facility determines approval for use.
that the information received is erroneous,
because a device-related adverse event did
not occur.  Documentation of such reports 2.13 Where to get forms and coding          
must also be retained in the facilitys MDR manual [803.11]
files for two (2) years.  
FDA forms 3500A and 3419,
2.9 Exemptions, variances, and              instructions, and the coding manual necessary
alternative reporting.  [803.19] to complete 3500A are available through the
Internet at: 
Upon written application or at its own
discretion, FDA may grant a user facility an http://www.fda.gov
exemption, a variance, or an alternative form
of reporting and may change the frequency of After June 1996, the above documents
reporting.  When FDA grants an exemption, and other MDR guidance will be available
variance, or alternative form of reporting, it from:
may impose other reporting requirements to
ensure the protection of public health.  It may National Technical Information Service
also revoke or modify any exemption,   Springfield, VA 22161
variance, or alterative form of reporting, if Telephone number (703) 487-4650.
necessary.
See Preface for a complete listing of
2.10 English reporting requirements            documents.
[803.13]
2.14 Where to submit reports . [803.12]
All required MDR reports must be in
English. All individual adverse event reports,
semiannual reports, and any additional
2.11  Reporting codes  [803.21] information should be sent to:
FDA has developed a coding manual for Food and Drug Administration
completing FDA Form 3500A.  The manual  Center for Devices and
contains hundreds of codes for adverse events      Radiological Health
and will be updated as needed.  The manual is Medical Device Reporting
available from various sources (see 2.13 for P.O. Box 3002
specifics). Rockville, MD 20847-3002
2.12 Electronic reporting  [803.14] Each report and its envelope should be
specifically identified, e.g., Semiannual
Any MDR report may be submitted Report or User Facility Report.
electronically with prior written consent
from the FDA.  Such consent is revocable.  If a user facility believes that there is a
Electronic report submissions include public health emergency, it should contact:
5 FDA Emergency Operations Branch, 
Office of Regional Operations, 
HFC-162
Telephone number 1-866-300-4374 or 301-796-8240
The telephone report should be followed by a
FAX report to 240-276-3454.
6 3.  WRITTEN PROCEDURES, RECORD
KEEPING, AND PUBLIC DISCLOSURE
User facilities must develop, implement, and maintain written procedures for reporting
adverse medical device events.  In addition to reporting device-related deaths and serious injuries,
user facilities must establish and maintain MDR files.
3.1 Written procedures  [803.17] 3.2 Files [803.18]  
Written procedures include internal User facilities must establish and main-
systems that provide: tain MDR event files.  MDR event files are
written or electronic files maintained by the
  for timely and effective identifica- user facility.  They must be prominently
tion, communication, and evalu- identified as such and filed to facilitate timely
ation of adverse events;  access.  MDR files must contain:
 a standardized review process and  information in the possession of the
procedure for determining whether user facility or references to infor-
or not an event is reportable; and  mation related to the event.  This
includes all documentation of the
 procedures to assure the timely reporting decisions and decision-
transmission of complete reports. making process; and 
User facilities must also establish,   copies of all completed MDR forms
implement, and maintain written procedures and other information submitted to
to assure compliance with documentation and FDA, distributors, and manufac-
record-keeping requirements.  This includes: turers.
 information that was evaluated to Records related to an adverse event,
determine if an event was whether reported or not, must be kept for two
reportable;  (2) years from the date of the event.  A user
facility must permit FDA employees to have
 all MDR reports and information access, at all reasonable times, to all required
submitted to FDA and manufac- records for copying and verification.
turers; 
3.3 Public availability of reports  [803.9]  
 any information that was evaluated
for the purpose of preparing the Certain information from MDR reports,
submission of semiannual reports; including any FDA record of a telephone 
and report, is available for public disclosure.  
Before public disclosure of a report, FDA will
 systems that ensure access to delete from the report:
information that facilitates timely
followup and inspection by FDA.  any information that constitutes
trade secret or confidential
commercial or financial
information;  
7  any personal, medical, and similar  a communication to a  manufacturer
information (including the serial of a device which is the subject of a
number of implanted devices) report required by a user facility; 
which would constitute an
unwarranted invasion of personal  a disclosure relating to an MDR 
privacy; and   report required by a manufacturer or
distributor; or 
 any names and other identifying
information of a third party  a disclosure to employees of the 
voluntarily submitting an MDR Department of Health and Human
report.  This includes physicians, Services and to the Department of
healthcare professionals, or other Justice or to duly authorized
hospital employees, unless they are committees and subcommittees of
designated the MDR contact the U.S. Congress.
person.
3.4 Disclaimers [803.16]
FDA will disclose to a patient
requesting a report all information in the Submission of a report or information
report concern-ing that patient.   under MDR, as well as any release by FDA
of that report or information, does not
FDA will not disclose the identity of a necessarily reflect that FDA or the submitter
user facility which makes a report except in admit or conclude that the device, the user
connection with:  facility, or its employees caused or
contributed to the reportable event. 
 an action brought to enforce the
medical device reporting require- MedWatch Form 3500A contains a 
ments, including the failure or  disclaimer statement at the bottom of the
refusal to furnish material or front page.
information; 
8 4.  ENFORCEMENT
FDA has criminal and civil penalty authority to enforce the MDR requirements.
4.1 Authority to enforce MDR  
Criminal penalty authority:  Failure to comply with the MDR requirements is a prohibited
act under the Food, Drug and Cosmetic Act (FD&C Act).  Commission of a prohibited act may
subject user facilities to injunction proceedings under Section 302 and criminal penalties under
Section 303 of the FD&C Act. 
Criminal penalties may be up to a $1,000 fine and one year imprisonment for the first offense 
if the offense was unintentional, and up to $10,000 and three years imprisonment for subsequent
offenses, or for intentional offense.
Civil penalty authority : Failure to comply with MDR reporting requirements may result in
civil penalties if the failure is a significant or knowing departure from the requirements, or a risk to
public health.  Civil penalties are fines imposed administratively by FDA for noncompliance with
the provisions of SMDA.  A person who receives a civil penalty is entitled to a hearing before an
Admini-strative Law Judge (ALJ).  The ALJs decision may be appealed to the Commissioner of
FDA, and the Commissioners decision may be appealed to a U.S. Court of Appeals.  Penalties
may not exceed $15,000 per violation or $1,000,000 for all violations adjudicated in a single
proceeding.
9 10 5.  DEFINITIONS
The MDR regulation contains some general terms that apply to user facilities, importers, and
manufacturers, as well as terms specific to user facility reporting.  For easy reference, sections of
the MDR regulation are included in brackets following the term.  The following definitions
generally apply to user facilities, but the reader should refer to the MDR rule for complete
definitions.
5.1 Ambulatory Surgical Facility        serious injury because of: 
[803.3(b)]
 device failure;
Ambulatory Surgical Facility (ASF)
means a distinct entity that operates for the  malfunction;
primary purpose of furnishing same day out-
patient surgical services to patients.  An ASF  improper or inadequate device
may be either an independent entity (i.e., not design;
a part of a provider of services or any other
facility) or operated by another medical entity  manufacture;
(e.g., under the common ownership,
licensure, or control of an entity).  An ASF is  labeling; or 
subject to the MDR regulation regardless of
whether or not it is licensed by a Federal,  user error
State, municipal, or local government, or
accredited by a recognized accreditation 5.4 Device user facility  [803.3(f)]
organization.  If an adverse event meets the
criteria for reporting, the ASF must report the Device user facility or user facility
event regardless of the nature or location of means a hospital (see definition 5.5), ambula-
the medical service provided by the ASF. tory surgical facility (see 5.1), nursing home
(see 5.10), outpatient diagnostic facility (see
5.2 Becomes Aware [803.3(c)] 5.11), or outpatient treatment facility (see
5.12) which is not a physicians office (see
A user facility "becomes aware" of an 5.14) as defined under [803.3 (w)].  School
MDR reportable event when medical per- nurse offices and employee health units are
sonnel, who are employed by or formally not user facilities.
affiliated with the facility, acquire
information that reasonably suggests that a 5.5 Hospital [803.3(i)]
reportable event has occurred.  Medical
personnel is defined in 5.9. Hospital means a distinct entity that
operates for the primary purpose of providing
5.3 Caused or Contributed to diagnostic, therapeutic (medical,
[803.3(d)] occupational, speech, physical, etc.), surgical,
and other patient services for specific and
A device may have "caused or general medical conditions.  Hospital
contributed to" a patients death or serious includes general, chronic disease,
injury, if the death or serious injury was or rehabilitative, psychiatric, and other special-
may have been attributed to the device or the purpose facilities.  A hospital may be either
device may have been a factor in the death or independent (i.e., not a part of a provider of
11 services or any other facility) or may be  has received a diploma or a degree
operated by another medical entity (e.g., in a professional or scientific
under the common ownership, licensure, or discipline; 
control of another entity). 
 is an employee responsible for    
A hospital is covered by the MDR receiving medical complaints or 
regulation regardless of whether or not it is adverse event reports; or 
licensed by a Federal, State, municipal, or
local government or accredited by a  is a supervisor of such persons.
recognized accreditation organization.  If an
adverse event meets the criteria for reporting, 5.10  Nursing Home  [803.3(s)]
the hospital must report that event regardless
of the nature or location of the medical Nursing home means an independent
service provided by the hospital. entity (i.e., not a part of a provider of services
or any other facility) or one operated by 
5.6 Malfunction [803.3(m)] another medical entity (e.g., under the
common ownership, licensure, or control of
A malfunction is failure of a device to an entity) that operates for the primary
meet its performance specifications or to purpose of providing: 
perform as intended.   Performance
specifications include all claims made in the  skilled nursing care and related
labeling for the device.  The intended services for persons who require
performance of a device refers to the intended medical or nursing care; 
use for which the device is labeled or
marketed.  (See 6.14 for user facilities.)  hospice care to the terminally ill; or 
5.7 MDR [803.3(p)]  services for the rehabilitation of the
injured, disabled, or sick.
MDR means a medical device report.
A nursing home is subject to this
5.8 MDR Reportable Event  [803.3(q)] regulation regardless of whether or not it is
licensed by a Federal, State, municipal, or
An "MDR reportable event" is an event local government, or whether or not it is
about which a user facility becomes aware of accredited by a recognized accreditation
information that reasonably suggests that a organization.  If an adverse event meets the
device has or may have caused or contributed criteria for report-ing, the nursing home must
to a death or serious injury. report that event regardless of the nature or
location of the medical service provided by
5.9   Medical Personnel  [803.3(r)] the nursing home. 
Medical personnel means an
individual who:  5.11 Outpatient Diagnostic Facility               
[803.3(t)]
 is licensed, registered, or certified
by a State, territory, or other Outpatient diagnostic facility means a
governing body to administer health distinct entity that: 
care; 
 operates for the primary purpose
12 ofconducting medical diagnostic physical therapy, and treatment for substance
tests on patients;  abuse.
 does not assume ongoing responsi- An outpatient treatment facility may be
bility for patient care; and  either independent (i.e., not a part of a
provider of services or any other facility) or
 provides its services for use by operated by another medical entity (e.g.,
other medical personnel.  Examples  under the common ownership, licensure, or
include diagnostic radiography, control of an entity).  
mammography, ultrasonography,
electrocardiography, magnetic An outpatient treatment facility is
covered by the MDR regulation regardless of
resonance imaging, computerized axial whether or not it is licensed by a Federal,
tomography, and in vitro testing. State, municipal, or local government or
whether or not it is accredited by a
An outpatient diagnostic facility may be recognized accreditation organization.  If an
either independent (i.e., not a part of a adverse event meets the criteria for reporting,
provider of services or any other facility) or the outpatient treatment facility must report
operated by another medical entity (e.g., that event regardless of the nature or location
under the common ownership, licensure, or of the medical service provided by the
control of an entity).   outpatient treatment facility.
An outpatient diagnostic facility is 5.13 Patient of the Facility  [803.3(v)]
covered by the MDR regulation regardless of
whether or not it is licensed by a Federal, Patient of the facility means any
State, municipal, or local government or is individual who is being diagnosed or treated
accredited by a recognized accreditation and/or receiving medical care at or under the
organization.  If an adverse event meets the control or authority of the facility.  For the
criteria for report-ing, the outpatient purpose of the MDR regulation, the definition
diagnostic facility must report that event encompasses employees of the faculty or
regardless of the nature or location of the individuals affiliated with the facility who, in
medical service provided by the outpatient the course of their duties, suffer a device-
diagnostic facility. related death or serious injury that has or may
have been caused or contributed to by a
5.12 Outpatient Treatment Facility                device used at the facility.
 [803.3(u)]  
5.14 Physicians Office [803.3(w)]
Outpatient Treatment Facility means a
distinct entity that operates for the primary Physicians office means a facility
purpose of providing nonsurgical therapeutic that operates as the office of a physician or
(medical, occupational, or physical) care on other healthcare professionals (e.g., dentist,
an outpatient basis or home healthcare.   Out- chiropractor, optometrist, nurse practitioner,
patient treatment facilities include ambulance school nurse offices, school clinics, employee
providers, rescue services, and home health- health clinics, or free-standing care units) for
care groups.  Examples of services provided the primary purpose of examination, evalua-
by outpatient treatment facilities include tion, and treatment or referral of patients.  A
cardiac defibrillation, chemotherapy, physicians office may be independent, a
radiotherapy, pain control, dialysis, speech or group practice, or part of a Health
13 Maintenance Organization. manufacturers and FDA.  This number
consists of three parts: 
5.15 Serious Injury [803.3(aa)]
 the user facilitys 10-digit Health
Serious injury means an injury or Care Financing Administration
illness that is: (HCFA) number.  If the HCFA
number is less than 10 digits, fill the
 life threatening;  remaining spaces with zeros;
 results in permanent impairment of  the four-digit calendar year in which
a body function or permanent the report is submitted; and 
damage to a body structure; or
 the four-digit sequence number of
 necessitates medical or surgical   the reports submitted for the year,
intervention to preclude permanent starting with 0001.  For example, a
damage or impairment.  complete number will appear as
follows: 1234567890-1996-0001.
5.16 Permanent [803.3(aa)(2)] If a facility has more than one HFCA
number, it must select one number that will
Permanent damage or impairment is be used for all of its MDR reports.  
irreversible damage or impairment that is not
trivial. 5.18 Work day [803.3(ee)]
5.17 User Facility Reporting Number           Work day means Monday through
   [803.3(dd)] Friday, excluding Federal holidays.
User facility reporting number means 
the number that uniquely identifies each
report submitted by a user facility to 
14 6.  FREQUENTLY ASKED QUESTIONS
The following are questions that FDA is frequently asked.  They provide background
information on MDR and attempt to explain some of FDAs policy decisions.
6.1 Why did Congress require medical       user facilities to determine when injuries
 device reporting  for user facilities? caused by devices must be reported to FDA.
Congress enacted the Safe Medical  Single definition of types of injuries
Devices Act of 1990 (SMDA) based on its  that must be reported  
review of the 1976 Amendments to the Food,
Drug, and Cosmetic (FD&C) Act.  Congress Section 5(a) of the 1992 Amendments
believed that significant changes were needed adopted a single definition for the types of
in the statutes, so that FDA could better injuries that user facilities, manufacturers,
protect the public health. importers, and distributors must report.  The
definition now requires reporting of an injury
As a result of Congressional hearings or illness that is:
and studies conducted by the General      
Accounting Office, Congress concluded that  life-threatening; or
FDA received less than adequate information      
about problems with medical devices.  With  results in permanent impairment of
better information, FDA can take appropriate a body function or permanent
actions to protect the public from hazardous damage to a body structure; or 
medical devices.
 necessitates medical or surgical 
6.2 How do the Medical Device         intervention to preclude permanent
Amendments of 1992 affect medical      impairment of a body function or
 device reporting? permanent damage to a body struc-
ture.  
The Medical Device Amendments 
of 1992 modified the reporting of adverse It deleted the SMDA requirement that an
device events as follows: injury must require immediate medical or
surgical intervention to preclude permanent
Adoption of a single reporting impairment or damage in order to qualify as a
standard   reportable adverse event.
Section 5(a) of the 1992 Amendments New authority to require reporting of  
revised the reporting requirements for user  other significant adverse device
facilities to report whenever the facility  experiences  
receives or otherwise becomes aware of
information that reasonably suggests that a The 1992 Amendments also authorized
device has or may have caused or FDA to issue regulations requiring the
contributed to the death, serious illness, or reporting of significant adverse device
serious injury of a patient of the facility.  This experiences other than deaths, serious
statutory language change adopts a single injuries, or serious illnesses that the agency
standard for manufacturers, importers, and determines are necessary to be reported.  This
15 provision will be implemented in a future 6.6   Our facility has more than one HCFA
regulation. number.  Which one should we use?
If a facility has more than one HCFA
6.3 What is the relationship between         number, it must select one to use for all MDR
medical device reporting and user       reports.  If a facility has no HCFA number, it
facility reporting? should use all zeros in the appropriate space
in its initial report (e.g., 0000000000-1995-0-
User facility reporting is a component or 001), and FDA will assign a number for
subset of FDAs Medical Device Reporting future use.  The number assigned will be used
(MDR) program.  Since 1984, manufacturers in FDAs record of that report and in any
and importers have been required to report correspondence with the user facility.  All
device-related deaths, serious injuries, and zeros should be used subsequent to the first
certain malfunctions.  SMDA amended the report, if the user does not receive the FDAs
medical device provisions of the Food, Drug, assigned number before the next report is
and Cosmetic Act by requiring user facilities submitted.   If a facility has multiple sites, the
to notify manufacturers and/or FDA of primary site can report centrally and use one
reportable events. reporting number for all sites.  A primary site
must provide FDA the name, address, and
6.4 What is MedWatch and how does it    HCFA number for each respective site with
relate to MDR and user facility its first report.
reporting?  
6.7 What is a device?
MedWatch is FDAs postmarket
surveillance program for reporting adverse The Food, Drug, and Cosmetic Act 
events associated with all medical products defines the term device as an instrument,
(drugs, medical devices, biologics, and apparatus, implement, machine, contrivance,
special nutritional products) regulated by implant, in vitro reagent, or other similar or
FDA.  Medical Device Reporting (MDR) is related article, including any component, part,
part of MedWatch, and user facility reporting or accessory, which is:  
is a subset of MDR.
   recognized in the official  National
6.5 What is the effective date of the final   Formulary, or the United States
MDR reporting requirements? Pharmacopeia, or any supplement
to them;
The user facility reporting section of
SMDA has been in effect since November 28,  intended for use in the diagnosis of
1991, even though a final regulation for MDR disease or other conditions, or in the
had not been published.  Although the cure, mitigation, treatment, or
original effective date for the final MDR rule prevention of disease in man or
was other animals; or 
April 11, 1996, FDA has extended the date to
July 31, 1996.  This will provide additional  intended to affect the structure or
time for user facilities and manufacturers to any function of the body of man or
prepare for the new requirements. other animals, and which  is not a
drug, i.e., the product does not
achieve its primary intended
16 purposes through chemical action 6.11 Does an HMO have to report?
within or on the body of man or
other animals and which is not User facilities (see 5.4 for definition)
dependent upon being metabolized that are part of an HMO or which belong to
for the achievement of its primary  an HMO must report.  
intended purposes.
6.12 Does a user facility need to designate 
Examples of medical devices (for which a contact person? [803.32(e)(4)]
FDA has received MDR reports) are hospital
beds, heart valves, ventilators, patient Yes.  A facility must designate a
restraints, x-ray machines, defibrillators, and contact person with whom FDA can conduct
bandages.  Generally, if it is used in medical its correspondence relating to MDR.  A third
practice and it is not a drug or biologic, it is a party may act as a contact person and submit 
device. reports for a user facility.  
6.8 Are ambulances and rescue services    6.13 Are user facilities required to invest-
required to report device-related  igate adverse events?   
adverse events?
In the final MDR rule, FDA has
Yes.  Ambulances and rescue services clarified that a user facility must report only
fall within the definition of user facility, information that is reasonably known to it
because they are outpatient treatment and is not required to investigate adverse
facilities.   Be-cause of the critical risks posed events by obtaining or evaluating information
by potential malfunctions of devices used by that is not reasonably known.  
such services, FDA has included them in the
definition of a user facility. Reasonably known information
includes information found in documents in
6.9 Why are home healthcare agencies     the posses-sion of the user facility and any
required to report under MDR? information that becomes available as a result
of reasonable followup within the facility. Of
FDA included home healthcare agencies course, the user facility must still make an
in the definition of a user facility because of initial determination as to whether or not an
the critical risks posed by potential malfunc- event should be reported under MDR.
tions of devices used in home healthcare.  
6.14 If a device malfunctions but does not
Home healthcare agencies (as well as cause a death or serious injury,
their device distributors) are likely to be the should a report be filed?
first to learn of problems with critical home
healthcare devices such as apnea monitors, User facilities are encouraged, but are
ventilators, infusion pumps, etc. not required, to report malfunctions that do
not result in a death or serious injury. 
6.10 Are foreign user facilities required      Although these reports are voluntary, FDA
to report under MDR? recommends that Form 3500A be used to
report to the manufacturer, since this form
No. Only those user facilities located provides for more detail about the event and
outside the United States that are operated by the device.   Such reports provide important
the U.S. Government are required to report information to the manufacturer and FDA
under MDR. concerning device safety.
17 6.18 Can a patients identity be                 
6.15 What does permanent damage or    protected?
permanent impairment mean in
the definition for serious injury? Yes.  A patients identity will be pro-
tected, because FDA does not release any
Permanent means irreversible patient identifiers to the public.  A reporter
impairment or damage to a body structure or may submit an identifier in lieu of a patients
function, excluding trivial impairment or name.  If FDA requires further patient infor-
damage.  While some cosmetic damage may mation, the request will be on an exception
be considered trivial, not all cosmetic damage basis. 
would be considered trivial.
6.19 Can MDR reports submitted to FDA 
6.16 Is temporary damage from use of    be used as evidence in a civil action?
a device reportable under MDR?
SMDA states that reports are not
Yes, if the temporary damage was admissible into evidence or otherwise used in
life-threatening.  Life-threatening events any civil action involving private parties, 
that may have been caused by or contributed unless the facility, individual, or physician
to a device must be reported, regardless of who made the report knew that the
whether or not the damage was temporary.  information in the report was false.
However, temporary damage that is not life
threatening is not reportable. 6.20 Is the identity of a reporter of an       
MDR event, such as a physician at      
6.17 Is an incident file the same as an      the hospital,  releasable under the      
MDR event  file?   Freedom of Information Act?
Because of comments received to the No.  FDA will not disclose the identity
proposed definition of incident files, FDA of physicians or other employees of the user
has changed the definition and renamed it facility, although the identity of the user
MDR event files.  MDR event files include facility and MDR contact may be disclosed
MDR reports filed (with FDA or other under certain circumstances described in 3.3. 
entities) and any documents related to the However, the user facilitys MDR contact
adverse event.  This includes documents person in Block F of MedWatch Form 3500A
relating to deliberations and decision-making is releasable.
processes used to determine if an event is an
MDR reportable event (even if the facility 6.21 Is user/operator error reportable    
decides not to submit an MDR.) under MDR?
The final MDR regulation also allows Yes.  The language of SMDA, as
the user facility to incorporate certain amended by the Medical Device Amend-
information by reference (such as medical ments of 1992, requires reporting of  all
records, patient files, and engineering reports) instances that reasonably suggest a device has
rather than include them in the MDR event or may have caused or contributed to a
file. device-related death, serious injury, or serious
illness.  FDA needs to be aware of events that 
18 and 11 injuries.  FDAs review also found
are related to user error any time such an that many incidents were the result of
error has or may have caused or contributed improper use of the device or inadequate
to a reportable event.  By receiving monitoring of the restrained patient.  In
information about user problems, FDA can response to these findings, FDA issued a
determine whether or not additional measures safety alerts to warn the public about dangers
are necessary to resolve the problem, e.g., associated with the use of patient restraints.  
relabeling or redesign of the device. In addition, FDA designated restraints as
prescrip-tion devices and issued a letter to
6.22 Must a user facility allow the manu- manufacturers to revise their labeling to
facturer of a device (involved in a prevent such improper use.  Without the
patients death or serious injury) MDR reports, FDA would not have known
access to it?  that these actions were needed to protect the 
public health.
FDA has no legal authority to require
that a device be returned to the manufacturer In 1995, FDA received over 100,000 
or that a manufacturer have access to the MDR reports, many of which were submitted 
device.  However, FDA believes that the by user facilities. 
manufacturer of a device should evaluate any
problems with its device.  FDA encourages
users to permit 
access to or return of the device to the
manufacturer for evaluation.
6.23 Does MDR really help prevent device
problems? 
Yes.  For example, a review of MDR
reports concerning patient restraints revealed
34 deaths 
19 20 Appendix A
21 22 Appendix B
23 24 Appendix C
ABBREVIATED INSTRUCTIONS FOR FDA FORM 3500A
SPECIFIC TO MEDICAL DEVICE REPORTING
GENERAL INSTRUCTIONS F. For use by user facility/distributor-devices only
1.  Complete all sections and items that apply and type all F2  Use the same report number as used on page 1 (see
entries.  item 4 of General Instructions).
2.  Use the following codes when information is not available F7 If follow-up report, record the user facility or distributor
for any item: NA - not applicable; NI - no information yet but initial report number in block F2 and the sequence
maybe later; UNK - unknown. number of this follow-up in the blank after follow-up,
3.  Enter dates in following format:  MM/DD/YY (e.g., June 3, e.g., for first follow-up enter 1, for second enter 2.  Do
1995 = 06/03/95.  If exact date not known, provide best not repeat previously submitted information on a follow-
estimate.  Use YYYY for year 2000 and beyond. up report.
4.  Enter the user facility report number or distributor report F10 Enter up to 3 patient and 3 device codes that most 
number and/or manufacturer report number in upper right  accurately describe the event.  Place only one code in
corner of page 1.  This has the format  NNNNNNNNNN-YYYY- each box.  Patient codes describe what happened to the
XXXXX where Ns represent the 10-character HCFA number patient as a result of the event and device codes
of the user facility or the 7 digit registration or identification describe device failures or problems during the event.
number of the manufacturer or distributor;  YYYY is the year of G. All manufacturers
the report and XXXXX is the 4 or 5 digit sequence number of G1 Enter the full name and address of the manufacturer
the report for the reporting year (see 21 CFR 803 or reporting site (contact office) including contact name. 
guidelines). The name and address of the manufacturing site, if
5. Attach a continuation page(s) when entries exceed allowed different, must also be included in this block.
space and indicate the report section and block number on G3 Check source of reported information.  If literature is
each page. checked, attach a copy of the article (in English) and
6. Use the coding manual to complete blocks F10, H3, & H6. record the literature citation in block H10.  Check the
Ordering information for the Coding Manual, Document study box when reporting an RPS/DPS study or
Number 799, is available by FAX at  (800) 899-0381 or postapproval study.
(301) 827-0111.  G5-6 Not for medical device use.
7.  If more than one patient was involved in the same event, G7 Check 5-day if  five-day report, Initial if first or initial
complete section A and blocks B2, B5, B6, B7, D10, and F10 submission, or follow-up if follow-up or supplemental
for each patient.  Enter the corresponding patient identifier in submission.   If follow-up report, do not repeat previously
each block. submitted information.  Place manufacturer report
8.  If more than one suspect medical device is involved, number of initial report in block G9 and the follow-up
complete section D for each.  Complete section F for one sequence number on the blank line in block G7 after
device and blocks F9, F10, F13 and F14 for each additional follow-up.
device.  Pair each section D with its corresponding section F G8 Not for medical device use.
by marking each as follows: Device 1", Device 2", etc. H. Device manufacturers only
H3 If device was evaluated, be sure to attach an evaluation
SPECIFIC INSTRUCTIONS                     summary.
A. Patient information H5 If the question is not relevant to the device (e.g., an x-ray
A1   Use an identifier, do not use patients name or SSN. machine), check no.
A2  Give patients age or best estimate and indicate the time H6 Codes must be entered for conclusions even if the 
unit used (years, months, days). device was not evaluated.
B. Adverse event or product problem H7 Check all that apply.
B1  Check box 1 if adverse event and/or box 2 if product H10 Enter any additional information, evaluation, or 
problem.  Adverse event is used when reporting a death clarification.  Do not duplicate previous information.
or serious injury.  Product problem is used for a H11 Provide the following additional, corrected or missing
malfunction that could lead to a death or serious injury if information, identifying each data item by the applicable
it were to recur. block and item number:
B2  Check appropriate event outcome.  Check disability if (1) any information missing on the user facility or
the device may have caused or contributed to a distributor report, including any missing or incomplete event
permanent injury or impairment. codes required by block F10, 
B5   Provide a complete description of event.  Do not use the (2) information corrected on the user facility or distributor
name of any person or institution.  If space is inadequate, report form after verification,  including any corrected event
use continuation sheet(s) as necessary. codes required by block F10
D. Suspect medical device (3) for each event code provided by the user facility or
D  The Suspect Medical Device is the device that may have distributor in block F10, a statement of whether the type of
caused or contributed to the MDR reportable event or the event represented by the code is addressed in the device
device that malfunctioned.  It is important that the device labeling, e.g., code # 1738 - labeled, code # 1701 - not
be properly identified and that all applicable information in labeled, and 
this block be completed. (4) an explanation of why any required information was
25 not provided and the steps taken to obtain such information.
26