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(i) In the medical or scientific literature, whether published or unpublished, that reasonably suggests that one of its marketed devices (A) may have caused or contributed to a death or serious injury or (B) has malfunctioned and that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

(b)(1) Whenever a manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices may have caused or contributed to a death or serious injury, the manufacturer or importer shall

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

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)(i) 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 09100201)

[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 additional 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 §§ 820.180 820.198. 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.

and

(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 09100201)

[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 imports devices

solely for use in the course of that individual's professional practice.

(b) Is a person who manufactures or imports devices intended for use in humans solely for such person's use in research or teaching and not for sale or under an investigational device exemption granted under part 812 or part 813.

PART 805-CARDIAC PACEMAKER REGISTRY

Subpart A-General Provisions

Sec.
805.1 Scope.
805.3

Definitions.

Subpart B-Submission of Information 805.10 Submission of information by physicians and providers.

805.20 How to submit information. 805.25 Confidentiality.

AUTHORITY: Sec. 1862(h) of the Social Security Act and sec. 2304(d) of the Deficit Reduction Act (42 U.S.C. 1395y(h), 1395y note).

SOURCE: 52 FR 27763, July 23, 1987, unless otherwise noted.

Subpart A-General Provisions

§ 805.1 Scope.

(a) This part provides for a nationwide cardiac pacemaker registry and requires any physician and any provider of services who requests or receives payment from Medicare for the implantation, removal, or replacement of permanent cardiac pacemakers and pacemaker leads to submit certain information to the registry. If the physician or the provider of services does not submit the information according to this part and 42 CFR 409.19(a) and 410.64(a), HCFA, which administers the Medicare program, will deny payment to the physician or the provider. FDA will use the information submitted to the registry to track the performance of permanent pacemakers and pacemaker leads and to perform studies and analyses regarding the use of the devices, and to transmit data to HCFA to assist HCFA in administering the Medicare program and to other Department of Health and

Human Services' components to carry out statutory responsibilities.

(b) Information submitted to the registry by a physician or a provider of services (and any release by FDA or HCFA of that information) does not necessarily reflect a conclusion by the submitter, FDA, or HCFA that the information constitutes an admission that a pacemaker device or lead failed to operate within its performance specifications. A submitter need not admit, and may deny, that the information submitted to the registry constitutes an admission that the pacemaker device or lead failed to operate within its performance specifications.

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

§ 805.3 Definitions.

(a) FDA means the Food and Drug Administration.

(b) HCFA means the Health Care Financing Administration.

(c) A pacemaker or pacemaker device is a device that produces periodic electrical impulses to stimulate the heart. It consists of two basic components: a pulse generator and one or more leads. See § 870.3610 for a more detailed definition.

(d) A pacemaker lead is a flexible, insulated wire connected at one end to a pacemaker's pulse generator and at the other end to the heart. It transmits electrical stimuli to and from the heart. See § 870.3680(b) for a more detailed definition.

(e) A physician is a doctor of medicine or osteopathy legally authorized to practice medicine and surgery by applicable laws of the State in which he or she performs such function or actions. (This definition includes an osteopathic practitioner.)

(f) A PRO is a Utilization and Quality Control Peer Review Organization that contracts with the Secretary of Health and Human Services to review health care services funded by the Medicare program to determine whether those services are reasonable, medically necessary, furnished in the appropriate setting, and are of a quality which meets professionally recognized standards.

(g) A provider is a hospital, skilled nursing facility, comprehensive outpatient rehabilitation facility, home health agency, or a hospice that has in effect an agreement to participate in Medicare.

(h) A warranty is an express or implied guarantee, under contract or State law, of the integrity of a pacemaker device or pacemaker lead and of the manufacturer's responsibility for the repair or replacement of defective parts of a pacemaker device or pacemaker lead.

(i) Any terms defined in section 201 of the Federal Food, Drug, and Cosmetic Act will have that definition.

Subpart B-Submission of Information

§ 805.10 Submission of information by physicians and providers.

A physician or a provider of services that requests or receives payment from Medicare for the implantation, removal, or replacement of a permanent cardiac pacemaker device or pacemaker lead shall submit the following information on a specified form to HCFA for inclusion in the pacemaker registry provided for by FDA under § 805.1:

(a) Provider number.

(b) Patient's health insurance claim number (HICN).

(c) Patient's name.

(d) Date of the procedure.

(e) Identification number (used by PRO's) and name of the physician who ordered the procedure.

(f) Identification number (used by PRO's) and name of the operating physician.

(g) For each device (pulse generator, atrial lead, ventricular lead) implanted during the procedure about which the report is being made: the name of the manufacturer, model number, serial number, and the warranty expiration date.

(h) For each device (pulse generator, atrial lead, ventricular lead) removed or replaced during the procedure about which the report is being made: the name of the manufacturer; model number; serial number; the warranty expiration date, if known; the date the device was initially implanted, if