A report or other information submitted by a reporting entity 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, or the reporting entity or its employees, caused or contributed to the reportable event. The reporting entity 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 reportable event.

§ 803.17 Written MDR procedures.

User facilities, importers, and manufacturers shall develop, maintain, and implement written MDR procedures for the following:

(a) Internal systems that provide for: (1) Timely and effective identification, communication, and evaluation of events that may be subject to medical device reporting requirements;

(2) A standardized review process/procedure for determining when an event meets the criteria for reporting under this part; and

(3) Timely transmission of complete medical device reports to FDA and/or manufacturers;

(b) Documentation and recordkeeping requirements for:

(1) Information that was evaluated to determine if an event was reportable;

(2) All medical device reports and information submitted to FDA and manufacturers;

(3) Any information that was evaluated for the purpose of preparing the submission of semiannual reports or certification; and

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

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000]

§ 803.18 Files and distributor records. (a) User facilities, importers, and manufacturers shall establish and maintain MDR event files. All MDR event files shall be prominently identified as such and filed to facilitate timely access.

(b)(1) For purposes of this part, "MDR event files" are written or electronic files maintained by user facilities, importers, and manufacturers. MDR event files may incorporate references to other information, e.g., medical records, patient files, engineering reports, etc., in lieu of copying and maintaining duplicates in this file. MDR event files must contain:

(i) Information in the possession of the reporting entity or references to information related to the adverse event, including all documentation of the entity's deliberations and decisionmaking processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable under this part.

(ii) Copies of all MDR forms, as required by this part, and other information related to the event that was submitted to FDA and other entities (e.g., an importer, distributor, or manufacturer).

(2) User facilities, importers, and manufacturers shall permit any authorized FDA employee during all reasonable times to access, to copy, and to verify the records required by this part.

(c) User facilities shall retain an MDR event file relating to an adverse event for a period of 2 years from the date of the event. Manufacturers and importers shall retain an MDR event file relating to an adverse event for a period of 2 years from the date of the event or a period of time equivalent to

the expected life of the device, whichever is greater. MDR event files must be maintained for the time periods described in this paragraph even if the device is no longer distributed.

(d)(1) A device distributor shall establish and maintain device complaint records containing any incident information, including any written, electronic, or oral communication, either received by or generated by the firm, that alleges deficiencies related to the identity (e.g., labeling), quality, durability, reliability, safety, effectiveness, or performance of a device. Information regarding the evaluation of the allegations, if any, shall also be maintained in the incident record. Device incident records shall be prominently identified as such and shall be filed by device, and may be maintained in written or electronic form. Files maintained in electronic form must be backed up.

(2) 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 of inclusion of the record in the file or for a period of time equivalent to the expected life of the device, whichever is greater, even if the distributor has ceased to distribute the device that is the subject of the record.

(3) 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.

(e) The manufacturer may maintain MDR event files as part of its complaint file, under § 820.198 of this chapter, provided that such records are prominently identified as MDR reportable events. A report submitted under this subpart A shall not be considered to comply with this part unless the event has been evaluated in accordance with the requirements of §§ 820.162 and 820.198 of this chapter. MDR files shall

contain an explanation of why any information required by this part was not submitted or could not be obtained. The results of the evaluation of each event are to be documented and maintained in the manufacturer's MDR event file.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000]

§ 803.19 Exemptions, variances, and alternative reporting requirements. (a) The following persons are exempt from the reporting requirements under this part.

(1) An individual who is a licensed practitioner who prescribes or administers devices intended for use in humans and who manufactures or imports devices solely for use in diagnosing and treating persons with whom the practitioner has a "physician-patient" relationship.

(2) An individual who manufactures devices intended for use in humans solely for such person's use in research or teaching and not for sale, including any person who is subject to alternative reporting requirements under the investigational device exemption regulations, parts 812 and 813 of this chapter, which require reporting of all adverse device effects.

(3) Dental laboratories, or optical laboratories.

(b) Manufacturers, importers, or user facilities may request exemptions or variances from any or all of the reporting requirements in this part. The request shall be in writing and include information necessary to identify the firm and device, a complete statement of the request for exemption, variance, or alternative reporting, and an explanation why the request is justified.

(c) FDA may grant in writing, to a manufacturer, importer, or user facility, an exemption, variance, or alternative from, or to, 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 period. These modifications may be initiated by a request as specified in this section, or at the discretion of FDA. When granting such modifications, FDA may impose other reporting requirements to ensure the protection of public health.

(d) FDA may revoke or modify in writing an exemption, variance, or alternative reporting requirements if FDA determines that protection of the public health justifies the modification or a return to the requirements as stated in this part.

(e) Firms granted a reporting modification by FDA shall provide any reports or information required by that approval. The conditions of the approval will replace and supersede the reporting requirement specified in this part until such time that FDA revokes or modifies the alternative reporting requirements in accordance with paragraph (d) of this section.

[60 FR 63597, Dec. 11, 1995, as amended at 61 FR 44615, Aug. 28, 1996; 65 FR 4119, Jan. 26, 2000; 65 FR 17136, Mar. 31, 2000]

Subpart B-Generally Applicable Requirements for Individual Adverse Event Reports

$803.20 How to report.

(a) Description of form. There are two versions of the MEDWATCH form for individual reports of adverse events. FDA Form 3500 is available for use by health professionals and consumers for the submission of voluntary reports regarding FDA-regulated products. FDA Form 3500A is the mandatory reporting form to be used for submitting reports by user facilities and manufacturers of FDA-regulated products. The form has sections that must be completed by all reporters and other sections that must be completed only by the user facility, importer, or manufacturer.

(1) The front of FDA Form 3500A is to be filled out by all reporters. The front of the form requests information regarding the patient, the event, the device, and the "initial reporter" (i.e., the first person or entity that submitted the information to the user facility, manufacturer, or importer).

(2) The back part of the form contains sections to be completed by user facilities, importers, and manufacturers. User facilities must complete section F; device manufacturers must complete sections G and H. Manufacturers are not required to recopy information submitted to them on a Form 3500A unless the information is being

copied onto an electronic medium. If the manufacturer corrects or supplies information missing from the other reporter's 3500A form, it should attach a copy of that form to the manufacturer's report form. If the information from the other reporter's 3500A form is complete and correct, the manufacturer can fill in the remaining information on the same form.

(b) Reporting standards. (1) User facilities are required to submit MDR reports to:

(i) The device manufacturer and to FDA within 10 days of becoming aware of information that reasonably suggests that a device has or may have caused or contributed to a death; or

(ii) The manufacturer within 10 days of becoming aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury. Such reports shall be submitted to FDA if the device manufacturer is not known.

(2) Importers are required to submit death and serious injury reports to FDA and the device manufacturer and submit malfunction reports to the manufacturer only:

(i) Within 30 days of becoming aware of information that reasonably suggests that a device has or may have caused or contributed to a death or serious injury.

(ii) Within 30 days of receiving information that a device marketed by the importer has malfunctioned and that such a 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.

(3) Manufacturers are required to submit MDR reports to FDA:

(i) Within 30 days of becoming aware of information that reasonably suggests that a device may have caused or contributed to a death or serious injury; or

(ii) Within 30 days of becoming aware of information that reasonably suggests a device has malfunctioned and that device or a similar device marketed by the manufacturer would be likely to cause a death or serious injury if the malfunction were to recur;

or

(iii) Within 5 days if required by § 803.53.

(c) Information that reasonably suggests a reportable event occurred. (1) Information that reasonably suggests that a device has or may have caused or contributed to an MDR reportable event (i.e., death, serious injury, and, for manufacturers, a malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur) includes any information, such as professional, scientific or medical facts and observations or opinions, that would reasonably suggest that a device has caused or may have caused or contributed to a reportable event.

(2) Entities required to report under this part do not have to report adverse events for which there is information that would cause a person who is qualified to make a medical judgment (e.g., a physician, nurse, risk manager, or biomedical engineer) to reach a reasonable conclusion that a device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury if it were to recur. Information which leads the qualified person to determine that a device-related event is or is not reportable must be contained in the MDR event files, as described in § 803.18.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000]

§ 803.21 Reporting codes.

(a) FDA has developed a MEDWATCH Mandatory Reporting Form Coding Manual for use with medical device reports. This manual contains codes for hundreds of adverse events for use with FDA Form 3500A. The coding manual is available from the Division of Small Manufacturer Assistance, Center for Devices and Radiological Health, 1350 Piccard Dr., Rockville, MD 20850, FAX 301-443-8818.

(b) FDA may use additional coding of information on the reporting forms or modify the existing codes on an ad hoc or generic basis. In such cases, FDA will ensure that the new coding information is available to all reporters.

§ 803.22 When not to file.

(a) Only one medical device report from the user facility, importer, or manufacturer is required under this part if the reporting entity becomes aware of information from multiple sources regarding the same patient and same event.

(b) A medical device report that would otherwise be required under this section is not required if:

(1) The user facility, importer, or manufacturer determines that the information received is erroneous in that a device-related adverse event did not occur. Documentation of such reports shall be retained in MDR files for time periods specified in § 803.18.

(2) The manufacturer or importer determines that the device was manufactured or imported by another manufacturer or importer. Any reportable event information that is erroneously sent to a manufacturer or importer shall be forwarded to FDA, with a cover letter explaining that the device in question was not manufactured or imported by that firm.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4120, Jan. 26, 2000]

Subpart C-User Facility Reporting Requirements

§ 803.30 Individual adverse event reports; user facilities.

(a) Reporting standard. A user facility shall submit the following reports to the manufacturer or to FDA, or both, as specified below:

(1) Reports of death. Whenever a user facility receives or otherwise becomes aware of information, from any source, that reasonably suggests that a device has or may have caused or contributed to the death of a patient of the facility, the facility shall as soon as practicable, but not later than 10 work days after becoming aware of the information, report the information required by §803.32 to FDA, on FDA Form 3500A, or an electronic equivalent as approved under § 803.14, and if the identity of the manufacturer is known, to the device manufacturer.

(2) Reports of serious injury. Whenever a user facility receives or otherwise becomes aware of information, from any

source, that reasonably suggests that a device has or may have caused or contributed to a serious injury to a patient of the facility, the facility shall, as soon as practicable but not later than 10 work days after becoming aware of the information, report the information required by §803.32, on FDA Form 3500A or electronic equivalent, as approved under § 803.14, to the manufacturer of the device. If the identity of the manufacturer is not known, the report shall be submitted to FDA. (b) Information that is reasonably known to user facilities. User facilities must provide all information required in this subpart C that is reasonably known to them. Such information includes information found in documents in the possession of the user facility and any information that becomes available as a result of reasonable followup within the facility. A user facility is not required to evaluate or investigate the event by obtaining or evaluating information that is not reasonably known to it.

§ 803.32 Individual adverse event report data elements.

User facility reports shall contain the following information, reasonably known to them as described in 803.30(b), which corresponds to the format of FDA Form 3500A:

(a) Patient information (Block A) shall contain the following:

(1) Patient name or other identifier; (2) Patient age at the time of event, or date of birth;

(3) Patient gender; and

(4) Patient weight.

(b) Adverse event or product problem (Block B) shall contain the following: (1) Identification of adverse event or product problem;

(2) Outcomes attributed to the adverse event, e.g., death; or serious injury, that is:

(i) Life threatening injury or illness; (ii) Disability resulting in permanent impairment of a body function or permanent damage to a body structure; or (iii) Injury or illness that requires intervention to prevent permanent impairment of a body structure or function;

(3) Date of event;

(4) Date of report by the initial reporter;

(5) Description of event or problem, including a discussion of how the device was involved, nature of the problem, patient followup or required treatment, and any environmental conditions that may have influenced the event;

(6) Description of relevant tests including dates and laboratory data; and (7) Description of other relevant history including pre- existing medical conditions.

(c) Device information (Block D) shall contain the following: (1) Brand name;

(9) Whether device was available for evaluation and whether device was returned to the manufacturer; if so, the date it was returned to the manufacturer; and

(10) Concomitant medical products and therapy dates. (Do not list products that were used to treat the event.) Initial (d) reporter information (Block E) shall contain the following:

(1) Name, address, and telephone number of the reporter who initially provided information to the user facility, manufacturer, or distributor;

(2) Whether the initial reporter is a health professional;

(3) Occupation; and

(4) Whether initial reporter also sent a copy of the report to FDA, if known. (e) User facility information (Block F) shall contain the following:

(1) Whether reporter is a user facility;

(2) User facility number; (3) User facility address; (4) Contact person;

(5) Contact person's telephone number;

(6) Date the user facility became aware of the event (month, day, year);