§804.28 Reporting form.

(a) Each distributor that submits a report on an MDR reportable event shall complete and submit the applicable portions of FDA form 3500A in so far as the information is known or should be known to the distributor, and submit it to FDA, and to the manufacturer as required by § 804.25.

(b) Each distributor shall submit the information requested on FDA form 3500A, including:

(1) Identification of the source of the report.

(i) Type of source that reported the event to thedistributor (e.g., lay user owner; lay user lessee, hospital, nursing home, outpatient diagnostic facility, outpatient treatment facility, ambulatory surgical facility);

(ii) Distributor report number;

(iii) Name, address, and telephone number of the reporting distributor and the source that reported the event to the distributor; and

(iv) Name of the manufacturer of the device.

(2) Date information.

(i) The date of the occurrence of the event;

(ii) The date the source that reported the event to the distributor became aware of the event;

(iii) The date the event was reported to the manufacturer and/or FDA; and (iv) The date of this report.

(3) The type of MDR reportable event, e.g., death, serious illness, serious injury, or malfunction, and whether an imminent hazard was involved;

(4) Patient information including age, sex, diagnosis, and medical status

immediately prior to the event and after the event;

(5) Device information including brand and labeled name, generic name, model number or catalog number or other identifying numbers, serial number or lot number, purchase date, expected shelf life/expiration date (if applicable), whether the device was labeled for single use, and date of implant (if applicable);

(6) Maintenance/service information data including the last date of service performed on the device, where service was performed, whether service documentation is available, and whether service was in accordance with the service schedule;

(7) Whether the device is available for evaluation and, if not, the disposition of the device;

(8) Description of the event.

(i) Who was operating or using the device when the eventoccurred;

(ii) Whether the device was being used as labeled or as otherwise intended;

(iii) The location of the event;

(iv) Whether there was multi-patient involvement, and if so, how many patients were involved;

(v) A list of any other devices whose performance may have contributed to the event and their manufacturers, and the results of any analysis or evaluation with respect to such device (or a statement of why no analysis or evaluation was performed); and

(vi) A complete description of the event including, but not limited to, what happened, how the device was involved, the nature of the problem, patient followup/treatment required, and any environmental conditions that may have influenced the event.

(9) The results of any analysis of the device and the event, including:

(i) The method of evaluation or an explanation of why no evaluation was necessary or possible;

(ii) The results and conclusions of the evaluation;

(iii) The corrective actions taken; and

(iv) The degree of certainty concerning whether the device caused or contributed to the reported event;

(10) The name, title, address, telephone number, and signature of the person who prepared the report.

§ 804.30 Annual certification.

Distributors required to report under this section shall submit a certification report to FDA by the date designated for annual registration for the firm in §807.21 of this chapter. This date will cover the period ending 1 month before the month of the scheduled date of mailing as indicated in § 807.21(a). The report will contain the following information:

telephone

(a) The name, address, number, and FDA registration number of the distributor;

(b) A statement certifying that:

(1) The distributor listed in paragraph (a) of this section has filed reports under this section during the previous 12-month period and all MDR reportable events have been submitted to FDA and/or to the appropriate manufacturer. The report will also include the number of death, serious injury or serious illness reports that were submitted to FDA, and the number of malfunction reports that were submitted to manufacturers; or

(2) The distributor listed in paragraph (a) of this section did not receive any reportable events during the previous 12-month period.

(c) The name, address, title, telephone number, and signature of the individual making the certification for the firm. This person must be a responsible person designated by the firm.

§ 804.31 Additional requirements.

Requests for additional information. If FDA determines that the protection of the public health requires information in addition to that included in the medical device reports submitted to FDA under this part, the distributor shall, upon FDA's request, submit such additional information. Any request by FDA under this section shall state the reason or purpose for which the information is being requested, and specify a due date for the submission of such information.

§ 804.32 Supplemental information.

(a) Only one MDR is required under this part if the distributor becomes

aware, from more than one source, of information concerning the same patient and the same event.

(b) An MDR that would otherwise be required under this section is not required by the distributor if:

(1) The distributor determines that the information received is erroneous in that a death, serious injury, serious illness, or the malfunction did not occur; or

(2) The distributor determines that the information received is erroneous in that the device that is the subject of the information was distributed by another distributor. A distributor shall forward to FDA any report that is erroneously sent to the distributor, with a cover letter explaining that the product in question is not distributed by that firm.

(c) A report or information submitted by a distributor under this part (and any release by FDA of that report or information) does not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, the establishment submitting the report, or employees thereof, caused or contributed to a death, serious injury, serious illness, or malfunction. A distributor need not admit, and may deny, that the report or information submitted under this part constitutes an admission that the device, the party submitting the report, or employees thereof, caused or contributed to a death or serious injury, serious illness, or malfunction.

§ 804.33 Alternative reporting requirements.

(a) Distributors may request exemptions from any or all of the reporting requirements in this part. These requests are required to be in writing and to include both the information necessary to identify the firm and device and an explanation why the request is justified.

(b) FDA may grant a distributor, in writing, an exemption from any or all of the reporting requirements in this part and may change the frequency of reporting to quarterly, semiannually, annually, or other appropriate time periods. In granting such exemptions, FDA may impose other reporting re

quirements to ensure the protection of public health and safety. FDA may also authorize the use of alternative reporting media such as magnetic tape or disk, in lieu of FDA forms.

(c) FDA may revoke alternative reporting options, in writing, if FDA determines that protection of the public health justifies a return to the requirements as stated in this part.

§804.34 Written MDR procedures.

Device distributors shall maintain and implement written MDR procedures in the following areas:

(a) Training and education programs informing employees about obligations under this section, including how to identify and report MDR reportable events;

(b) Internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, a standardized review process/procedure for determining when an event meets the criteria for reporting under this part, and timely transmission of complete MDR's to FDA and/or manufacturers; and

(c) Documentation and recordkeeping requirements for:

(1) Information that may be the subject of an MDR;

(2) All MDR's and information submitted to FDA and manufacturers;

(3) Information that facilitates the submission of certification reports; and

(4) Systems that ensure access to information that facilitates timely followup and inspection by FDA.

§804.35 Files.

(a) A device distributor shall establish a device complaint file in accordance with §820.198 of this chapter and maintain a record of any information, including any written or oral communication, received by the distributor concerning all events that were considered for possible reporting under this part. Device incident records shall be prominently identified as such and shall be filed by device. The file shall also contain a copy of any MDR along with any additional information submitted to FDA under this part. A distributor shall maintain records that

document the submission of copies of MDR's to manufacturers.

(b) A device distributor shall retain copies of the records required to be maintained under this section for a period of 2 years from the date that the report or additional information is submitted to FDA under §804.25, or for a period of time equivalent to the design and expected life of the device, whichever is greater, even if the distributor has ceased to distribute the device that is the subject of the report or the additional information.

(c) A device distributor shall maintain the device complaint files established under this section at the distributor's principal business establishment. A distributor that is also a manufacturer may maintain the file at the same location as the manufacturer maintains its complaint file under §§ 820.180 and 820.198 of this chapter. A device distributor shall permit any authorized FDA employee, during all reasonable times, to have access to, and to copy and verify, the records required by this part.

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.

(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 known; whether a device that was replaced was left in the body; if the device was not left in the body, whether it was returned to the manufacturer.

(Information collection requirements approved by the Office of Management and Budget under control number 0910-0234)

§805.20 How to submit information.

Information shall be submitted to the registry in the form and manner required under general instructions of the Medicare program (see 42 CFR 409.19(a) and 410.64(a)).

§805.25 Confidentiality.

(a) FDA and HCFA will keep confidential, and will not reveal to the public, any specific information that identifies by name a recipient of any pacemaker device or lead or that would otherwise identify a specific recipient.

(b) Public disclosure of all other information under this part will be governed by the Freedom of Information Act (5 U.S.C. 552), the Privacy Act of 1974 (5 U.S.C. 552a), the Department of Health and Human Services' public information regulations (45 CFR part 5), FDA's public information regulations (21 CFR part 20), and HCFA's public information regulations (subpart B of 42 CFR part 401).