(3) The Food and Drug Administration may permit the use of an absorbency test method different from the test method specified in this section if each of the following conditions is met:

(i) The manufacturer presents evidence, in the form of a citizen petition submitted in accordance with the requirements of § 10.30 of this chapter, demonstrating that the alternative test method will yield results that are equivalent to the results yielded by the test method specified in this section; and

(ii) FDA approves the method and has published notice of its approval of the alternative test method in the FEDERAL REGISTER.

(g) Any menstrual tampon intended to be dispensed by a vending machine is exempt from the requirements of this section.

(h) Any menstrual tampon that is not labeled as required by paragraphs (c), (d), and (e) of this section and that is initially introduced or initially delivered for introduction into commerce after March 1, 1990, is misbranded under sections 201(n), 502 (a) and (f) of the act.

(Information collection requirements contained in paragraphs (e) and (f) were approved by the Office of Management and Budget under control number 0910-0257) [47 FR 26989, June 22, 1982, as amended at 54 FR 43771, Oct. 26, 1989]

Subpart A-General Provisions

§ 803.1 Scope.

(a) FDA is requiring a device manufacturer or importer to report to FDA whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned and that the device or any other 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. These reports will 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, a device importer is required to establish and maintain a complaint file 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.

(b) This part supplements, and does not supersede, other provisions of this subchapter, including the provisions of Part 820, such as the requirements under § 820.162 that a manufacturer investigate the failure of a device or any of its components to meet its performance specifications and to establish and maintain a written record of the investigation, including the manufacturer's conclusions and followup, the requirements under § 820.198 that a manufacturer establish and maintain a complaint file, and the requirements under § 820.180 that a manufacturer allow access to, and copying of, these files by any authorized FDA representative.

(c) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21, unless otherwise noted.

(c) "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 person 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.

any

(d) "Manufacturer" means person who is required to register under Part 807, other than a person who initially distributes a device imported into the United States.

(e) "Person" includes any individual, partnership, corporation, association, scientific or academic establishment, Government agency, or organizational unit thereof, or any other legal entity.

(f) "Information that reasonably suggests" a conclusion means: (1) Information (such as professional, scientific, or medical facts or opinions) from which a reasonable person would reach the conclusion, and (2) a statement to a manufacturer or importer by a health care professional (e.g., a doctor of medicine, osteopathy, dental surgery, podiatry, or chiropractic, or an optometrist, pharmacist, or a registered nurse, or a hospital administrator), reaching the conclusion.

(g) A "remedial action" is any recall, repair, modification, adjustment, relabeling, destruction, inspection (including patient monitoring), notification, or any other action that is initiated by a manufacturer or importer in response to information that it receives or otherwise becomes aware of and that reasonably suggests that one of its marketed devices (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned and that the device or any other

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.

(h) A "serious injury" is an injury that (1) is life threatening, (2) results in permanent impairment of a body function or permanent damage to body structure, or (3) necessitates medical or surgical intervention by a health care professional to (i) preclude permanent impairment of a body function or permanent damage to body structure or (ii) relieve unanticipated temporary impairment of a body function or unanticipated temporary damage to body structure. Temporary impairment of a body function or temporary damage to body structure is unanticipated if reference to such impairment or damage is not made in the labeling for the device or, if such reference is made in the labeling for the device, the manufacturer or importer of the device determines that such impairment or damage 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.

(i) Any term defined in section 201 of the Federal Food, Drug, and Cosmetic Act shall have that meaning, unless otherwise defined in this part.

§ 803.9 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.

(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; and (2) any personnel, medical, and similar information disclosure of which would constitute a clearly unwarranted invasion of personal privacy under § 20.63; Provided, However, that except for the information that constitutes trade secret or confidential commercial or financial information under § 20.61, FDA will disclose to a patient who requests a report all the informa

tion in the report concerning that patient.

Subpart B-Reports and Records

§ 803.24 Reports by manufacturers and importers.

(a) A manufacturer or importer shall submit to FDA a report containing the information listed in paragraph (c) of this section whenever the manufacturer or importer:

(1) Receives or otherwise becomes aware of oral or written information that reasonably suggests that:

(i) A death or serious injury has occurred and that one of the manufacturer's or importer's marketed devices may have caused or contributed to a death or serious injury; or

(ii) One of the manufacturer's or importer's marketed devices has malfunctioned and that the device or any other 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.

(2) Receives or otherwise becomes aware of information:

(i) In the medical or scientific literature, whether published or unpublished, that reasonably suggests that one of its marketed devices (A) may have caused or contributed to a death or serious injury or (B) has malfunctioned and that the device or any other 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; or

(ii) Through its own research, testing, evaluation, servicing, or maintenance of one of its devices, that reasonably suggests that one of its marketed devices malfunctions and that the device or any other 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.

report to FDA by telephone as soon as possible, but no later than within 5 calendar days of initial receipt of the information. The manufacturer or importer shall include in the telephone report the information listed in paragraph (c) of this section. The manufacturer or importer shall follow the telephone report with a written report submitted to FDA within 15 working days of initial receipt of the information.

(2) Whenever a manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices has malfunctioned and that the device or any other 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, the manufacturer or importer shall report in writing or by telephone to FDA as soon as the information listed in paragraph (c) of this section has been obtained, but in no event later than 15 working days after initial receipt of the information. The manufacturer or importer shall follow any report made by telephone with a written report submitted to FDA within 15 working days of initial receipt of the information.

(c) A medical device telephone report or written report is required to:

(1) Identify the device, including its brand name and common or usual name and, to the extent known, the model, catalog, or other identification number or code of the device, and the manufacturing lot or serial number of the device.

(2) Identify the manufacturer or, in the case of an imported device, identify the importer and the foreign manufacturer;

(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)(i) of this section, the de

scription 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 rea

sonably 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