(3) Identify, by name, address, and telephone number, the individual making the report to FDA;

(4) Describe, to the extent known, the event giving rise to the information received by the manufacturer or importer, including (i) whether any deaths or serious injuries have occurred and (ii) the number of persons who died or were seriously injured. (If the report is required under paragraph (a)(2)(1) of this section, the description of the event shall include a copy of the article.);

(5) Identify, by name and address, the person submitting the information to the manufacturer or importer;

(6) State whether the manufacturer or importer intends to submit additional information, and, if so, when such information will be submitted; and

(7) State whether the reported event has occurred or is occurring more frequently or with greater severity than is stated in the labeling for the device or, if there is not any pertinent statement in the labeling, than is usual for the device, if such information is available.

(d)(1) A manufacturer or importer shall report to FDA as required under this part each time it receives or otherwise becomes aware of information described in paragraph (a) of this section, even if an event of the same or a similar nature has been reported previously to FDA. A medical device report is required under paragraph (a) of this section even if the manufacturer or importer believes that the event that requires a report is due to user error, the failure to service or maintain the device properly, the use of the device beyond its labeled useful life, or any other reason not listed under paragraph (d) (2) or (3) of this section.

(2) Only one medical device report is required under paragraph (a) of this section if the manufacturer or importer becomes aware, from more than one source, of information concerning the same patient and the same event.

(3) A medical device report is not required if within the time period specified under paragraph (b) of this section, the manufacturer or importer determines that:

(i) The information received under paragraph (a)(1)(i) of this section is erroneous in that a death or serious injury has not occurred; or

(ii) The information received under paragraph (a)(1)(i) or (ii) of this section is erroneous in that the device that is the subject of the information was manufactured or imported by another manufacturer or importer;

or

(iii) Although the manufacturer or importer has received or otherwise became aware of information that reasonably suggests that a malfunction has occurred, each of the following applies:

(A) A death or serious injury has not occurred;

(B) The device's labeling sets forth information concerning the potential for death or the type of serious injury that the malfunction may cause or contribute to;

(C) The device's labeling describes the malfunction, and the routine service, repair, or maintenance instructions to correct the malfunction;

(D) The malfunction has occurred or is occurring at or below the frequency and severity stated in the labeling for the device or, if there is not any pertinent statement in the labeling, at or below the frequency and severity that are usual for the device; and

(E) The malfunction does not lead the manufacturer or importer to undertake a remedial action involving any device other than the device product in which the malfunction occurred.

(4) FDA may notify a manufacturer or importer, in writing, that medical device reports of a particular type of event are no longer required.

(e) If FDA determines that the protection of the public health requires information in addition to that included in the medical device report submitted to FDA under paragraph (b) of this section, a manufacturer or importer shall, upon FDA's request, submit such additional information. Any request by FDA under this paragraph will be in writing, state the reason or purpose for which the information is being requested, and specify a due date for the submission of such information. Additional items that may be requested include:

(1) Model, catalog, or other identification number or code of the device.

(2) Manufacturing lot or serial number of the device.

(3) A complete description of the event giving rise to the information received by the manufacturer or importer, including (i) whether any deaths or serious injuries have occurred and (ii) the number of persons who died or were seriously injured. If a complete description is unavailable, the manufacturer or importer shall explain the reason for the unavailability of such description.

(4) Any evaluation of the risk of death or serious injury, including failure analysis, and copies of any laboratory testing or analyses available to or used by the manufacturer or importer.

(5) Any available evaluation by a practitioner, such as a physician or dentist, licensed by law to use or order the use of the device, of the event described in the medical device report.

(6) Any evaluation or other determination available to or used by the manufacturer or importer as to whether the event described in the medical device report is or is not attributable to the device and the basis for such determination.

(7)(1) All the information on the basis of which the manufacturer or importer determined that the reported event has occurred or is occurring more frequently or with greater severity than is stated in the labeling for the device or, if there is not any pertinent statement in the labeling, than is usual for the device; and

(ii) any evaluation or analysis available to or used by the manufacturer or importer in making this determination.

(8) If the manufacturer or importer determines that the event described in the medical device report is attributable to the device, an outline of the plan for remedial action or, if the manufacturer or importer determines that a remedial action is unnecessary, the basis for such determination.

(9) A copy of any proposed remedial action communication and the names and addresses of recipients of the communication.

(10) Information concerning the device's manufacture, e.g., the total number manufactured or the number in the same batch, lot, or equivalent unit of production, the location and date of manufacture, and the device's expiration date, if any.

(11) Information concerning the device's distribution, e.g., the location and number of devices in inventory stock and distribution channels, a list of all consignees, and the dates of distribution.

(f) A report or information submitted by a manufacturer or importer under this section (and any release by FDA of that report or information) does not necessarily reflect a conclusion by the manufacturer, importer, or FDA that the report or information constitutes an admission that the device caused or contributed to a death or serious injury or malfunctioned. A manufacturer or importer need not admit, and may deny, that the report or information submitted under this section constitutes an admission that the device caused or contributed to a death or serious injury or malfunctioned.

(Approved by the Office of Management and Budget under control number 0910-0201) [49 FR 36348, Sept. 14, 1984, as amended at 49 FR 48273, Dec. 12, 1984]

§803.31 Complaint files.

(a) An importer shall establish a complaint file and maintain a record of any information, including any written or oral communication, received by the importer concerning a death, serious injury, or device malfunction that requires a report under § 803.24. The file also is required to contain a copy of any medical device report submitted to FDA under §803.24(b) and any additional information submitted to FDA under §803.24(e).

(b) An importer shall retain copies of records maintained under paragraph (a) of this section for a period of 2 years from the date that the medical device report or addi

tional information is submitted to FDA under §803.24 (b) or (e), even if the importer has ceased importing the device that is the subject of the report or the additional information.

(c) An importer shall maintain the complaint file established under this section at the importer's principal business establishment. An importer that also is a manufacturer may maintain the file at the same location as the manufacturer maintains its complaint file under §§ 820.180 and 820.198. An importer shall permit any authorized FDA employee at all reasonable times to have access to and to copy and verify the records contained in the complaint file.

(d) A manufacturer shall retain copies of records of any information, including any written or oral communication, received by the manufacturer concerning a death, serious injury, or device malfunction that requires a report under §803.24. The manufacturer also shall retain a copy of any medical device report submitted to FDA under §803.24(b) and any additional information submitted to FDA under § 803.24(e). The manufacturer shall retain the records referred to in this paragraph for a period of 2 years from the date that the report or additional information is submitted to FDA under § 803.24 (b) or (e) or for a period of time equivalent to the design and expected life of the device, whichever is greater. The manufacturer may maintain as part of its complaint file under § 820.198 the records referred to in this paragraph. The manufacturer shall permit any authorized FDA employee at all reasonable times to have access to and to copy and verify the records referred to in this paragraph. (Approved by the Office of Management and Budget under control number 0910-0201)

[49 FR 36348, Sept. 14, 1984, as amended at 49 FR 48273, Dec. 12, 1984]

§ 803.33 Where to submit a report.

(a) Any telephone report required under this part shall be provided to 301-427-7500.

(b) Any written report or additional information required under this part shall be submitted to the Product Monitoring Branch (HFZ-351), Center for Devices and Radiological Health, Food and Drug Administration, 1390 Piccard Dr., Rockville, MD 20850.

[49 FR 36348, Sept. 14, 1984, as amended at 53 FR 11252, Apr. 6, 1988; 55 FR 11168, Mar. 27, 1990]

§803.36 Exemptions from reporting.

A manufacturer or importer otherwise subject to this part is exempt from reporting as required under this part, if the manufacturer or importer:

(a) Is a practitioner who is licensed by law to prescribe or administer devices intended for use in humans and who manufactures or

(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 §804.35, and to permit any authorized FDA employee at all reasonable times to have access to, and to copy and verify, the records contained in this file. This part supplements, and does not supersede,

(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 specifica

tions 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.

(1) 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.

§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 § 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 $20.63 of this chapter; provided, that, except for the information under § 20.61 of this chapter, FDA will disclose to a patient who requests a report all the information in the report concerning that patient.

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 §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 §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 §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.