[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.3]

[Page 44-48]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 803_MEDICAL DEVICE REPORTING--Table of Contents
 
                      Subpart A_General Provisions
 
Sec.  803.3  How does FDA define the terms used in this part?

    Some of the terms we use in this part are specific to medical device 
reporting and reflect the language used in the statute (law). Other 
terms are more general and reflect our interpretation of the law. This 
section defines the following terms as used in this part:
    Act means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 301 et 
seq., as amended.
    Ambulatory surgical facility (ASF) means a distinct entity that 
operates for the primary purpose of furnishing same day outpatient 
surgical services to patients. An ASF may be either an independent 
entity (i.e., not a part of a provider of services or any other 
facility) or operated by another medical entity (e.g., under the common 
ownership, licensure, or control of an entity). An ASF is subject to 
this regulation regardless of whether it is licensed by a Federal, 
State, municipal, or local government or regardless of whether it is 
accredited by a recognized accreditation organization. If an adverse 
event meets the criteria for reporting, the ASF must report that event 
regardless of the nature or location of the medical service provided by 
the ASF.
    Become aware means that an employee of the entity required to report 
has acquired information that reasonably suggests a reportable adverse 
event has occurred.
    (1) If you are a device user facility, you are considered to have 
``become aware'' when medical personnel, as defined in this section, who 
are employed by or otherwise formally affiliated with your facility, 
obtain information about a reportable event.
    (2) If you are a manufacturer, you are considered to have become 
aware of an

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event when any of your employees becomes aware of a reportable event 
that is required to be reported within 30 calendar days or that is 
required to be reported within 5 work days because we had requested 
reports in accordance with Sec.  803.53(b). You are also considered to 
have become aware of an event when any of your employees with management 
or supervisory responsibilities over persons with regulatory, 
scientific, or technical responsibilities, or whose duties relate to the 
collection and reporting of adverse events, becomes aware, from any 
information, including any trend analysis, that a reportable MDR event 
or events necessitates remedial action to prevent an unreasonable risk 
of substantial harm to the public health.
    (3) If you are an importer, you are considered to have become aware 
of an event when any of your employees becomes aware of a reportable 
event that is required to be reported by you within 30 days.
    Caused or contributed means that a death or serious injury was or 
may have been attributed to a medical device, or that a medical device 
was or may have been a factor in a death or serious injury, including 
events occurring as a result of:
    (1) Failure;
    (2) Malfunction;
    (3) Improper or inadequate design;
    (4) Manufacture;
    (5) Labeling; or
    (6) User error.
    Device family. (1) Device family means a group of one or more 
devices manufactured by or for the same manufacturer and having the 
same:
    (i) Basic design and performance characteristics related to device 
safety and effectiveness,
    (ii) Intended use and function, and
    (iii) Device classification and product code.
    (2) You may consider devices that differ only in minor ways not 
related to safety or effectiveness to be in the same device family. When 
grouping products in device families, you may consider factors such as 
brand name and common name of the device and whether the devices were 
introduced into commercial distribution under the same 510(k) or 
premarket approval application (PMA).
    Device user facility means a hospital, ambulatory surgical facility, 
nursing home, outpatient diagnostic facility, or outpatient treatment 
facility as defined in this section, which is not a physician's office, 
as defined in this section. School nurse offices and employee health 
units are not device user facilities.
    Distributor means any person (other than the manufacturer or 
importer) who furthers the marketing of a device from the original place 
of manufacture to the person who makes final delivery or sale to the 
ultimate user, but who does not repackage or otherwise change the 
container, wrapper, or labeling of the device or device package. If you 
repackage or otherwise change the container, wrapper, or labeling, you 
are considered a manufacturer as defined in this section.
    Expected life of a device means the time that a device is expected 
to remain functional after it is placed into use. Certain implanted 
devices have specified ``end of life'' (EOL) dates. Other devices are 
not labeled as to their respective EOL, but are expected to remain 
operational through activities such as maintenance, repairs, or 
upgrades, for an estimated period of time.
    FDA, we, or us means the Food and Drug Administration.
    Five-day report means a medical device report that must be submitted 
by a manufacturer to us under Sec.  803.53, on FDA Form 3500A or an 
electronic equivalent approved under Sec.  803.14, within 5 work days.
    Hospital means a distinct entity that operates for the primary 
purpose of providing diagnostic, therapeutic (such as medical, 
occupational, speech, physical), surgical, and other patient services 
for specific and general medical conditions. Hospitals include general, 
chronic disease, rehabilitative, psychiatric, and other special-purpose 
facilities. A hospital may be either independent (e.g., not a part of a 
provider of services or any other facility) or may be operated by 
another medical entity (e.g., under the common ownership, licensure, or 
control of another entity). A hospital is covered by this

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regulation regardless of whether it is licensed by a Federal, State, 
municipal or local government or whether it is accredited by a 
recognized accreditation organization. If an adverse event meets the 
criteria for reporting, the hospital must report that event regardless 
of the nature or location of the medical service provided by the 
hospital.
    Importer means any person who imports a device into the United 
States and who furthers the marketing of a device from the original 
place of manufacture to the person who makes final delivery or sale to 
the ultimate user, but who does not repackage or otherwise change the 
container, wrapper, or labeling of the device or device package. If you 
repackage or otherwise change the container, wrapper, or labeling, you 
are considered a manufacturer as defined in this section.
    Malfunction means the failure of a device to meet its performance 
specifications or otherwise perform as intended. Performance 
specifications include all claims made in the labeling for the device. 
The intended performance of a device refers to the intended use for 
which the device is labeled or marketed, as defined in Sec.  801.4 of 
this chapter.
    Manufacturer means any person who manufactures, prepares, 
propagates, compounds, assembles, or processes a device by chemical, 
physical, biological, or other procedure. The term includes any person 
who either:
    (1) Repackages or otherwise changes the container, wrapper, or 
labeling of a device in furtherance of the distribution of the device 
from the original place of manufacture;
    (2) Initiates specifications for devices that are manufactured by a 
second party for subsequent distribution by the person initiating the 
specifications;
    (3) Manufactures components or accessories that are devices that are 
ready to be used and are intended to be commercially distributed and 
intended to be used as is, or are processed by a licensed practitioner 
or other qualified person to meet the needs of a particular patient; or
    (4) Is the U.S. agent of a foreign manufacturer.
    Manufacturer or importer report number. Manufacturer or importer 
report number means the number that uniquely identifies each individual 
adverse event report submitted by a manufacturer or importer. This 
number consists of the following three parts:
    (1) The FDA registration number for the manufacturing site of the 
reported device, or the registration number for the importer. If the 
manufacturing site or the importer does not have an establishment 
registration number, we will assign a temporary MDR reporting number 
until the site is registered in accordance with part 807 of this 
chapter. We will inform the manufacturer or importer of the temporary 
MDR reporting number;
    (2) The four-digit calendar year in which the report is submitted; 
and
    (3) The five-digit sequence number of the reports submitted during 
the year, starting with 00001. (For example, the complete number will 
appear as follows: 1234567-1995-00001.)
    MDR means medical device report.
    MDR reportable event (or reportable event) means:
    (1) An event that user facilities become aware of that reasonably 
suggests that a device has or may have caused or contributed to a death 
or serious injury; or
    (2) An event that manufacturers or importers become aware of that 
reasonably suggests that one of their marketed devices:
    (i) May have caused or contributed to a death or serious injury, or
    (ii) Has malfunctioned and that the device or a similar device 
marketed by the manufacturer or importer would be likely to cause or 
contribute to a death or serious injury if the malfunction were to 
recur.
    Medical personnel means an individual who:
    (1) Is licensed, registered, or certified by a State, territory, or 
other governing body, to administer health care;
    (2) Has received a diploma or a degree in a professional or 
scientific discipline;
    (3) Is an employee responsible for receiving medical complaints or 
adverse event reports; or
    (4) Is a supervisor of these persons.
    Nursing home means:

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    (1) An independent entity (i.e., not a part of a provider of 
services or any other facility) or one operated by another medical 
entity (e.g., under the common ownership, licensure, or control of an 
entity) that operates for the primary purpose of providing:
    (i) Skilled nursing care and related services for persons who 
require medical or nursing care;
    (ii) Hospice care to the terminally ill; or
    (iii) Services for the rehabilitation of the injured, disabled, or 
sick.
    (2) A nursing home is subject to this regulation regardless of 
whether it is licensed by a Federal, State, municipal, or local 
government or whether it is accredited by a recognized accreditation 
organization. If an adverse event meets the criteria for reporting, the 
nursing home must report that event regardless of the nature or location 
of the medical service provided by the nursing home.
    Outpatient diagnostic facility. (1) Outpatient diagnostic facility 
means a distinct entity that:
    (i) Operates for the primary purpose of conducting medical 
diagnostic tests on patients,
    (ii) Does not assume ongoing responsibility for patient care, and
    (iii) Provides its services for use by other medical personnel.
    (2) Outpatient diagnostic facilities include outpatient facilities 
providing radiography, mammography, ultrasonography, 
electrocardiography, magnetic resonance imaging, computerized axial 
tomography, and in vitro testing. An outpatient diagnostic facility may 
be either independent (i.e., not a part of a provider of services or any 
other facility) or operated by another medical entity (e.g., under the 
common ownership, licensure, or control of an entity). An outpatient 
diagnostic facility is covered by this regulation regardless of whether 
it is licensed by a Federal, State, municipal, or local government or 
whether it is accredited by a recognized accreditation organization. If 
an adverse event meets the criteria for reporting, the outpatient 
diagnostic facility must report that event regardless of the nature or 
location of the medical service provided by the outpatient diagnostic 
facility.
    Outpatient treatment facility means a distinct entity that operates 
for the primary purpose of providing nonsurgical therapeutic (medical, 
occupational, or physical) care on an outpatient basis or in a home 
health care setting. Outpatient treatment facilities include ambulance 
providers, rescue services, and home health care groups. Examples of 
services provided by outpatient treatment facilities include the 
following: Cardiac defibrillation, chemotherapy, radiotherapy, pain 
control, dialysis, speech or physical therapy, and treatment for 
substance abuse. An outpatient treatment facility may be either 
independent (i.e., not a part of a provider of services or any other 
facility) or operated by another medical entity (e.g., under the common 
ownership, licensure, or control of an entity). An outpatient treatment 
facility is covered by this regulation regardless of whether it is 
licensed by a Federal, State, municipal, or local government or whether 
it is accredited by a recognized accreditation organization. If an 
adverse event meets the criteria for reporting, the outpatient treatment 
facility must report that event regardless of the nature or location of 
the medical service provided by the outpatient treatment facility.
    Patient of the facility means any individual who is being diagnosed 
or treated and/or receiving medical care at or under the control or 
authority of the facility. This includes employees of the facility or 
individuals affiliated with the facility who, in the course of their 
duties, suffer a device-related death or serious injury that has or may 
have been caused or contributed to by a device used at the facility.
    Physician's office means a facility that operates as the office of a 
physician or other health care professional for the primary purpose of 
examination, evaluation, and treatment or referral of patients. Examples 
of physician offices include dentist offices, chiropractor offices, 
optometrist offices, nurse practitioner offices, school nurse offices, 
school clinics, employee health clinics, or freestanding care units. A 
physician's office may be independent, a group practice, or part of a 
Health Maintenance Organization.

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    Remedial action means any action other than routine maintenance or 
servicing of a device where such action is necessary to prevent 
recurrence of a reportable event.
    Serious injury means an injury or illness that:
    (1) Is life-threatening,
    (2) Results in permanent impairment of a body function or permanent 
damage to a body structure, or
    (3) Necessitates medical or surgical intervention to preclude 
permanent impairment of a body function or permanent damage to a body 
structure.
    Permanent means irreversible impairment or damage to a body 
structure or function, excluding trivial impairment or damage.
    Shelf life means the maximum time a device will remain functional 
from the date of manufacture until it is used in patient care. Some 
devices have an expiration date on their labeling indicating the maximum 
time they can be stored before losing their ability to perform their 
intended function.
    User facility report number means the number that uniquely 
identifies each report submitted by a user facility to manufacturers and 
to us. This number consists of the following three parts:
    (1) The user facility's 10-digit Centers for Medicare and Medicaid 
Services (CMS) number (if the CMS number has fewer than 10 digits, fill 
the remaining spaces with zeros);
    (2) The four-digit calendar year in which the report is submitted; 
and
    (3) The four-digit sequence number of the reports submitted for the 
year, starting with 0001. (For example, a complete user facility report 
number will appear as follows: 1234560000-2004-0001. If a user facility 
has more than one CMS number, it must select one that will be used for 
all of its MDR reports. If a user facility has no CMS number, it should 
use all zeros in the appropriate space in its initial report (e.g., 
0000000000-2004-0001). We will assign a number for future use and send 
that number to the user facility. This number is used in our record of 
the initial report, in subsequent reports, and in any correspondence 
with the user facility. If a facility has multiple sites, the primary 
site may submit reports for all sites and use one reporting number for 
all sites if the primary site provides the name, address, and CMS number 
for each respective site.)
    Work day means Monday through Friday, except Federal holidays.