[Title 21 CFR 804]
[Code of Federal Regulations (annual edition) - April 1, 1999 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION,]
[Subchapter H - MEDICAL DEVICES]
[Part 804 - MEDICAL DEVICE DISTRIBUTOR REPORTING]
[From the U.S. Government Printing Office]
21FOOD AND DRUGS81999-04-011999-04-01falseMEDICAL DEVICE DISTRIBUTOR REPORTING804PART 804FOOD AND DRUGSFOOD AND DRUG ADMINISTRATION,MEDICAL DEVICES
PART 804--MEDICAL DEVICE DISTRIBUTOR REPORTING--Table of Contents
Subpart A--General Provisions
Sec.
804.1 Scope.
804.3 Definitions.
804.9 Public availability of reports.
Subpart B--Reports and Records
804.25 Reports by distributors.
804.27 Where to submit a report.
804.28 Reporting form.
804.30 Annual certification.
804.31 Additional requirements.
804.32 Supplemental information.
804.33 Alternative reporting requirements.
804.34 Written MDR procedures.
804.35 Files.
Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.
Source: 58 FR 46519, Sept. 1, 1993, unless otherwise noted.
Subpart A--General Provisions
Sec. 804.1 Scope.
(a) FDA is requiring medical device distributors to report deaths,
serious illnesses, and serious injuries that are attributed to medical
devices. Distributors are also required to report certain device
malfunctions and to submit a report to FDA annually certifying the
number of medical device reports filed during the preceding year, or
that no reports were filed. These reports enable FDA to protect the
public health by helping to ensure that devices are not adulterated or
misbranded and are otherwise safe and effective for their intended use.
In addition, device distributors are required to establish and maintain
complaint files or incident files as described in Sec. 804.35, and to
permit any authorized FDA employee at all reasonable times to have
[[Page 54]]
access to, and to copy and verify, the records contained in this file.
This part supplements, and does not supersede, other provisions of this
subchapter, including the provisions of part 820 of this chapter.
(b) References in this part to regulatory sections of the Code of
Federal Regulations are to chapter I of title 21, unless otherwise
noted.
Sec. 804.3 Definitions.
(a) Act means the Federal Food, Drug, and Cosmetic Act.
(b)-(c) [Reserved]
(d) Distributor means any person, including any person who imports a
device into the United States, 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. One who repackages or otherwise changes the container,
wrapper, or labeling, is a manufacturer under Sec. 804.3(k).
(e) Distributor Report Number means the number that uniquely
identifies each report submitted by a distributor. Distributors who
receive or submit reports shall use their seven digit FDA registration
number, calendar year that the report is received, and a sequence
number. For example, the complete number will appear as follows:
1234567-1991-0001. Distributor report numbers shall also be required on
FDA form 3500A.
(f) FDA means the Food and Drug Administration.
(g) [Reserved]
(h) Incident files are those files containing documents or other
information, which are related to adverse events that may have been
caused by a device.
(i) Information that reasonably suggests that there is a probability
that a device has caused or contributed to a death or serious injury or
serious illness means information, including professional, scientific,
or medical facts, observations, or opinions, which would cause a
reasonable person to believe that a device caused or contributed to a
death, serious injury, or serious illness.
(j) Malfunction means the failure of a device to meet any of its
performance specifications or otherwise to perform as intended.
Performance specifications include all claims made in the labeling for
the device. The intended performance of a device refers to the objective
intent of the persons legally responsible for the labeling of the
device. The intent is determined by such persons' expressions or may be
shown by the circumstances surrounding the distribution of the device.
This objective intent may, for example, be shown by labeling claims,
advertising matter, or oral or written statements by such persons or
their representatives. It also may be shown by the circumstances that
the device is, with the knowledge of such persons or their
representatives, offered and used to perform a function for which it is
neither labeled nor advertised.
(k) Manufacturer means any person who manufactures, prepares,
propagates, compounds, assembles, or processes a device chemically,
physically, biologically, or by other procedures. The term includes any
person who:
(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, to the person who makes final
delivery or sale to the ultimate user or consumer;
(2) Initiates specifications for devices that are manufactured by a
second party for subsequent distribution by the person initiating the
specifications; or
(3) Manufactures components or accessories which are devices that
are ready to be used and are intended to be commercially distributed and
are 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.
(l) MDR means medical device report.
(m) MDR reportable event means:
(1) The event for which a distributor, other than an importer,
required to report under this part has received or become aware of
information that reasonably suggests that there is a probability that a
device has caused or contributed to a death, serious illness, or serious
injury; or
[[Page 55]]
(2) The event for which an importer required to report under this
part has received or become aware of information that reasonably
suggests that a device may have caused or contributed to a death or
serious injury; or
(3) A malfunction, for which a distributor, other than an importer,
required to report under this part has received or become aware of
information that reasonably suggests that there is a probability that
the device, if the malfunction were to recur, would be likely to cause
or contribute to a death, serious illness, or serious injury; or
(4) A malfunction, for which an importer required to report under
this part has received or become aware of information that reasonably
suggests that a device has malfunctioned and that such device or a
similar device would be likely to cause or contribute to a death or
serious injury if the malfunction were to recur.
(n)-(p) [Reserved]
(q) Permanent means nonreversible impairment or damage.
(r) Probability, probable, or probably means, for purposes of this
section, that a person would have reason to believe, based upon an
analysis of the event and device, that the device has caused or
contributed to an adverse event. This term does not signify statistical
probability.
(s) A remedial action is any recall, repair, modification,
adjustment, relabeling, destruction, inspection, patient monitoring,
notification, or any other action relating to a device that is initiated
by a distributor, in response to information that it receives or
otherwise becomes aware of, that reasonably suggests that one of its
marketed devices has caused or contributed to an MDR reportable event.
(t) Serious illness means an event that:
(1) Is life threatening;
(2) Results in permanent impairment of a body function or permanent
damage to the body structure; or
(3) Necessitates immediate medical or surgical intervention to
preclude permanent impairment of a body function or permanent damage to
a body structure.
(u) Serious injury means an event 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.
(v) [Reserved]
(w) Work day means Monday through Friday excluding Federal holidays.
Federal holidays include New Year's Day, Martin Luther King Jr.'s
Birthday, Presidents' Day, Memorial Day, Independence Day, Labor Day,
Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day.
(x) Any term defined in section 201 of the act shall have the same
definition unless otherwise defined in this part.
Sec. 804.9 Public availability of reports.
(a) Any report, including any FDA record of a telephone report,
submitted under this part is available for public disclosure in
accordance with part 20 of this chapter.
(b) Before public disclosure of a report, FDA will delete from the
report:
(1) Any information that constitutes trade secret or confidential
commercial or financial information under Sec. 20.61 of this chapter;
and
(2) Any personnel, medical, and similar information, including the
serial numbers of implanted devices, which would constitute a clearly
unwarranted invasion of personal privacy under Sec. 20.63 of this
chapter; provided, that, except for the information under Sec. 20.61 of
this chapter, FDA will disclose to a patient who requests a report all
the information in the report concerning that patient.
Subpart B--Reports and Records
Sec. 804.25 Reports by distributors.
(a)(1) A distributor, other than an importer, shall submit to FDA a
report, and a copy of such report to the manufacturer, containing the
information required by Sec. 804.28 on FDA form 3500A as soon as
practicable, but not later than 10 working days after the distributor
receives or otherwise becomes aware of information from any
[[Page 56]]
source, including user facilities, individuals, or medical or scientific
literature, whether published or unpublished, that reasonably suggests
that there is a probability that a device marketed by the distributor
has caused or contributed to a death, serious illness, or serious
injury.
(2) An importer shall submit to FDA a report, and a copy of such
report to the manufacturer, containing the information required by
Sec. 804.28 on FDA form 3500A as soon as practicable, but not later than
10 working days after the importer receives or otherwise becomes aware
of information from any source, including user facilities, individuals,
or medical or scientific literature, whether published or unpublished,
that reasonably suggests that one of its marketed devices may have
caused or contributed to a death or serious injury.
(b)(1) A distributor, other than an importer, shall submit to the
manufacturer a report containing information required by Sec. 804.28 on
FDA form 3500A, as soon as practicable, but not later than 10 working
days after the distributor receives or otherwise becomes aware of
information from any source, including user facilities, individuals, or
through the distributor's own research, testing, evaluation, servicing,
or maintenance of one of its devices, that one of the devices marketed
by the distributor has malfunctioned and such information reasonably
suggests that there is a probability that the device or any other device
marketed by the distributor would cause a death, serious illness, or
serious injury, if the malfunction were to recur.
(2) An importer shall submit to the manufacturer a report containing
information required by Sec. 804.28 on FDA form 3500A, as soon as
practicable, but not later than 10 working days after the importer
receives or otherwise becomes aware of information from any source,
including user facilities, individuals, or through the distributor's own
research, testing, evaluation, servicing, or maintenance of one of its
devices, that one of the devices marketed by the importer has
malfunctioned and that such device or a similar device marketed by the
importer would be likely to cause or contribute to a death or serious
injury if the malfunction were to recur.
(c) Distributors as defined in part 897 of this chapter shall submit
medical device reports concerning cigarettes and smokeless tobacco under
this part only for adverse events related to contamination.
[58 FR 46519, Sept. 1, 1993, as amended at 61 FR 44615, Aug. 28, 1996]
Sec. 804.27 Where to submit a report.
(a) Any telephone report required under this part shall be provided
to 301-427-7500.
(b) Any facsimile report required under this part shall be provided
to 301-881-6670.
(c) Any written report or additional information required under this
part shall be submitted to:
Food and Drug Administration,
Center for Devices and Radiological Health,
Distributor Report,
P.O. Box 3002,
Rockville, MD 20847-3002.
Sec. 804.28 Reporting form.
(a) Each distributor that submits a report on an MDR reportable
event shall complete and submit the applicable portions of FDA form
3500A in so far as the information is known or should be known to the
distributor, and submit it to FDA, and to the manufacturer as required
by Sec. 804.25.
(b) Each distributor shall submit the information requested on FDA
form 3500A, including:
(1) Identification of the source of the report.
(i) Type of source that reported the event to thedistributor (e.g.,
lay user owner; lay user lessee, hospital, nursing home, outpatient
diagnostic facility, outpatient treatment facility, ambulatory surgical
facility);
(ii) Distributor report number;
(iii) Name, address, and telephone number of the reporting
distributor and the source that reported the event to the distributor;
and
(iv) Name of the manufacturer of the device.
(2) Date information.
(i) The date of the occurrence of the event;
[[Page 57]]
(ii) The date the source that reported the event to the distributor
became aware of the event;
(iii) The date the event was reported to the manufacturer and/or
FDA; and
(iv) The date of this report.
(3) The type of MDR reportable event, e.g., death, serious illness,
serious injury, or malfunction, and whether an imminent hazard was
involved;
(4) Patient information including age, sex, diagnosis, and medical
status immediately prior to the event and after the event;
(5) Device information including brand and labeled name, generic
name, model number or catalog number or other identifying numbers,
serial number or lot number, purchase date, expected shelf life/
expiration date (if applicable), whether the device was labeled for
single use, and date of implant (if applicable);
(6) Maintenance/service information data including the last date of
service performed on the device, where service was performed, whether
service documentation is available, and whether service was in
accordance with the service schedule;
(7) Whether the device is available for evaluation and, if not, the
disposition of the device;
(8) Description of the event.
(i) Who was operating or using the device when the eventoccurred;
(ii) Whether the device was being used as labeled or as otherwise
intended;
(iii) The location of the event;
(iv) Whether there was multi-patient involvement, and if so, how
many patients were involved;
(v) A list of any other devices whose performance may have
contributed to the event and their manufacturers, and the results of any
analysis or evaluation with respect to such device (or a statement of
why no analysis or evaluation was performed); and
(vi) A complete description of the event including, but not limited
to, what happened, how the device was involved, the nature of the
problem, patient followup/treatment required, and any environmental
conditions that may have influenced the event.
(9) The results of any analysis of the device and the event,
including:
(i) The method of evaluation or an explanation of why no evaluation
was necessary or possible;
(ii) The results and conclusions of the evaluation;
(iii) The corrective actions taken; and
(iv) The degree of certainty concerning whether the device caused or
contributed to the reported event;
(10) The name, title, address, telephone number, and signature of
the person who prepared the report.
Sec. 804.30 Annual certification.
(a) All distributors required to report under this section shall
submit an annual certification report to FDA, on FDA Form 3381, or
electronic equivalent as approved under Sec. 803.14 of this chapter. The
date for submission of certification coincides with the date for the
firm's annual registration, as designated in Sec. 807.21 of this
chapter. The certification period will be the 12-month period ending 1
month before the certification date, except that the first certification
period shall cover at least a 6-month period from the effective date of
this section, ending 1 month before the certification date.
(b) The distributor shall designate, as the certifying official, an
individual with oversight responsibilities for, and knowledge of, the
firm's MDR reporting system. A distributor may determine, based upon its
organizational structure, that one individual cannot oversee or have
complete knowledge of the operation of the reporting system at all
organizational components or distribution sites owned by the firm. In
this circumstance, the firm may designate more than one certifying
official (one for each component or site), each of whom will sign a
certification statement pertaining to their respective identified
organizational component(s) or site(s), provided that all organizational
components and sites are covered under a certification statement.
(c) The report shall contain the following information:
(1) Name, address, and FDA registration number or FDA assigned
identification number of the firm;
[[Page 58]]
(2) Name, title, address, telephone number, signature, and date of
signature of the person making the certification;
(3) Name, address, and FDA registration number or FDA assigned
identification number for the distributor covered by the certification,
and the number of reports submitted for devices distributed by the
distributor;
(4) A statement certifying that:
(i) The individual certifying for the firm has read the MDR
requirements under part 804;
(ii) The firm has established a system to implement MDR reporting;
(iii) Following the procedures of its MDR reporting system, the firm
submitted the specified number of reports, or no reports, during the
certification period; and
(iv) The certification is made to the best of the certifying
official's knowledge and belief.
[62 FR 13306, Mar. 20, 1997]
Sec. 804.31 Additional requirements.
Requests for additional information. If FDA determines that the
protection of the public health requires information in addition to that
included in the medical device reports submitted to FDA under this part,
the distributor shall, upon FDA's request, submit such additional
information. Any request by FDA under this section shall state the
reason or purpose for which the information is being requested, and
specify a due date for the submission of such information.
Sec. 804.32 Supplemental information.
(a) Only one MDR is required under this part if the distributor
becomes aware, from more than one source, of information concerning the
same patient and the same event.
(b) An MDR that would otherwise be required under this section is
not required by the distributor if:
(1) The distributor determines that the information received is
erroneous in that a death, serious injury, serious illness, or the
malfunction did not occur; or
(2) The distributor determines that the information received is
erroneous in that the device that is the subject of the information was
distributed by another distributor. A distributor shall forward to FDA
any report that is erroneously sent to the distributor, with a cover
letter explaining that the product in question is not distributed by
that firm.
(c) A report or information submitted by a distributor under this
part (and any release by FDA of that report or information) does not
necessarily reflect a conclusion by the party submitting the report or
by FDA that the report or information constitutes an admission that the
device, the establishment submitting the report, or employees thereof,
caused or contributed to a death, serious injury, serious illness, or
malfunction. A distributor need not admit, and may deny, that the report
or information submitted under this part constitutes an admission that
the device, the party submitting the report, or employees thereof,
caused or contributed to a death or serious injury, serious illness, or
malfunction.
Sec. 804.33 Alternative reporting requirements.
(a) Distributors may request exemptions from any or all of the
reporting requirements in this part. These requests are required to be
in writing and to include both the information necessary to identify the
firm and device and an explanation why the request is justified.
(b) FDA may grant a distributor, in writing, an exemption from any
or all of the reporting requirements in this part and may change the
frequency of reporting to quarterly, semiannually, annually, or other
appropriate time periods. In granting such exemptions, FDA may impose
other reporting requirements to ensure the protection of public health
and safety. FDA may also authorize the use of alternative reporting
media such as magnetic tape or disk, in lieu of FDA forms.
(c) FDA may revoke alternative reporting options, in writing, if FDA
determines that protection of the public health justifies a return to
the requirements as stated in this part.
Sec. 804.34 Written MDR procedures.
Device distributors shall maintain and implement written MDR
procedures in the following areas:
[[Page 59]]
(a) Training and education programs informing employees about
obligations under this section, including how to identify and report MDR
reportable events;
(b) Internal systems that provide for timely and effective
identification, communication, and evaluation of events that may be
subject to MDR requirements, a standardized review process/procedure for
determining when an event meets the criteria for reporting under this
part, and timely transmission of complete MDR's to FDA and/or
manufacturers; and
(c) Documentation and recordkeeping requirements for:
(1) Information that may be the subject of an MDR;
(2) All MDR's and information submitted to FDA and manufacturers;
(3) Information that facilitates the submission of certification
reports; and
(4) Systems that ensure access to information that facilitates
timely followup and inspection by FDA.
Sec. 804.35 Files.
(a) A device distributor shall establish a device complaint file in
accordance with Sec. 820.198 of this chapter and maintain a record of
any information, including any written or oral communication, received
by the distributor concerning all events that were considered for
possible reporting under this part. Device incident records shall be
prominently identified as such and shall be filed by device. The file
shall also contain a copy of any MDR along with any additional
information submitted to FDA under this part. A distributor shall
maintain records that document the submission of copies of MDR's to
manufacturers.
(b) A device distributor shall retain copies of the records required
to be maintained under this section for a period of 2 years from the
date that the report or additional information is submitted to FDA under
Sec. 804.25, or for a period of time equivalent to the design and
expected life of the device, whichever is greater, even if the
distributor has ceased to distribute the device that is the subject of
the report or the additional information.
(c) A device distributor shall maintain the device complaint files
established under this section at the distributor's principal business
establishment. A distributor that is also a manufacturer may maintain
the file at the same location as the manufacturer maintains its
complaint file under Secs. 820.180 and 820.198 of this chapter. A device
distributor shall permit any authorized FDA employee, during all
reasonable times, to have access to, and to copy and verify, the records
required by this part.