0458 21cfr803 1

Pt. 803

21 CFR Ch. I (4–1–06 Edition)

panel of the device packaging, the outside package, container or wrapper,
and the immediate device package,
container, or wrapper.
(f) Devices that have packaging containing natural rubber latex that contacts humans, as described in paragraph (b) of this section, shall bear the
following statement in bold print on
the device labeling:
‘‘Caution: The Packaging of This
Product Contains Natural Rubber
Latex Which May Cause Allergic Reactions.’’
This statement shall appear on the
packaging that contains the natural
rubber, and the outside package, container, or wrapper.
(g) Devices that have packaging containing dry natural rubber that contacts humans, as described in paragraph (b) of this section, shall bear the
following statement in bold print on
the device labeling:
‘‘The Packaging of This Product Contains Dry Natural Rubber.’’
This statement shall appear on the
packaging that contains the natural
rubber, and the outside package, container, or wrapper.–
(h) Devices that contain natural rubber that contacts humans, as described
in paragraph (b) of this section, shall
not contain the term ‘‘hypoallergenic’’
on their labeling.
(i) Any affected person may request
an exemption or variance from the requirements of this section by submitting a citizen petition in accordance
with § 10.30 of this chapter.
(j) Any device subject to this section
that is not labeled in accordance with
paragraphs (d) through (h) of this section and that is initially introduced or
initially delivered for introduction into
interstate commerce after the effective
date of this regulation is misbranded
under sections 201(n) and 502(a), (c), and
(f) of the act (21 U.S.C. 321(n) and
352(a), (c), and (f)).

PART 803—MEDICAL DEVICE
REPORTING
Subpart A—General Provisions
Sec.
803.1 What does this part cover?
803.3 How does FDA define the terms used
in this part?
803.9 What information from the reports do
we disclose to the public?
803.10 Generally, what are the reporting requirements that apply to me?
803.11 What form should I use to submit reports of individual adverse events and
where do I obtain these forms?
803.12 Where and how do I submit reports
and additional information?
803.13 Do I need to submit reports in
English?
803.14 How do I submit a report electronically?
803.15 How will I know if you require more
information about my medical device report?
803.16 When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?
803.17 What are the requirements for developing, maintaining, and implementing
written MDR procedures that apply to
me?
803.18 What are the requirements for establishing and maintaining MDR files or
records that apply to me?
803.19 Are there exemptions, variances, or
alternative forms of adverse event reporting requirements?

Subpart B—Generally Applicable Requirements for Individual Adverse Event Reports
803.20 How do I complete and submit an individual adverse event report?
803.21 Where can I find the reporting codes
for adverse events that I use with medical device reports?
803.22 What are the circumstances in which
I am not required to file a report?

Subpart C—User Facility Reporting
Requirements
803.30 If I am a user facility, what reporting
requirements apply to me?
803.32 If I am a user facility, what information must I submit in my individual adverse event reports?
803.33 If I am a user facility, what must I include when I submit an annual report?

NOTE TO § 801.437: Paragraphs (f) and (g) are
stayed until June 27, 1999, as those regulations relate to device packaging that uses
‘‘cold seal’’ adhesives.
[62 FR 51029, Sept. 30, 1997, as amended at 63
FR 46175, Aug. 31, 1998]

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Food and Drug Administration, HHS

§ 803.3

Subpart D—Importer Reporting
Requirements

device distributor, you must maintain
records (files) of incidents, but you are
not required to report these incidents.
(b) This part supplements and does
not supersede other provisions of this
chapter, including the provisions of
part 820 of this chapter.
(c) References in this part to regulatory sections of the Code of Federal
Regulations are to chapter I of title 21,
unless otherwise noted.

803.40 If I am an importer, what kinds of individual adverse event reports must I
submit, when must I submit them, and to
whom must I submit them?
803.42 If I am an importer, what information must I submit in my individual adverse event reports?

Subpart E—Manufacturer Reporting
Requirements

§ 803.3 How does FDA define the terms
used in this part?

803.50 If I am a manufacturer, what reporting requirements apply to me?
803.52 If I am a manufacturer, what information must I submit in my individual
adverse event reports?
803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report?
803.55 I am a manufacturer, in what circumstances must I submit a baseline report, and what are the requirements for
such a report?
803.56 If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are
the requirements for such reports?
803.58 Foreign manufacturers.

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

AUTHORITY: 21 U.S.C. 352, 360, 360i, 360j, 371,
374.
SOURCE: 70 FR 9519, July 13, 2005, unless
otherwise noted

Subpart A—General Provisions
§ 803.1 What does this part cover?
(a) This part establishes the requirements for medical device reporting for
device user facilities, manufacturers,
importers, and distributors. If you are
a device user facility, you must report
deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse
event files, and submit summary annual reports. If you are a manufacturer
or importer, you must report deaths
and serious injuries that your device
has or may have caused or contributed
to, you must report certain device malfunctions, and you must establish and
maintain adverse event files. If you are
a manufacturer, you must also submit
specified followup and baseline reports.
These reports help us to protect the
public health by helping to ensure that
devices are not adulterated or misbranded and are safe and effective for
their intended use. If you are a medical

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