§ 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 § 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

(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.