21 C.F.R. Subpart B—Generally Applicable Requirements for Individual Adverse Event Reports
Title 21 - Food and Drugs
(a) What form must I complete and submit? There are two versions of the MEDWATCH form for individual reports of adverse events. If you are a health professional or consumer, you may use the FDA Form 3500 to submit voluntary reports regarding FDA-regulated products. If you are a user facility, importer, or manufacturer, you must use the FDA Form 3500A to submit mandatory reports about FDA-regulated products. (1) If you are a user facility, importer, or manufacturer, you must complete the applicable blocks on the front of FDA Form 3500A. The front of the form is used to submit information about the patient, the event, the device, and the “initial reporter” (i.e., the first person or entity who reported the information to you). (2) If you are a user facility, importer, or manufacturer, you must complete the applicable blocks on the back of the form. If you are a user facility or importer, you must complete block F. If you are a manufacturer, you must complete blocks G and H. If you are a manufacturer, you do not have to recopy information that you received on a Form 3500A unless you are copying the information onto an electronic medium. If you are a manufacturer and you are correcting or supplying information that is missing from another reporter's Form 3500A, you must attach a copy of that form to your report form. If you are a manufacturer and the information from another reporter's Form 3500A is complete and correct, you may fill in the remaining information on the same form and submit it to us. (b) To whom must I submit reports and when? (1) If you are a user facility, you must submit MDR reports to: (i) The manufacturer and to us no later than 10 work days after the day that you become aware of information that reasonably suggests that a device has or may have caused or contributed to a death; or (ii) The manufacturer no later than 10 work days after the day that you become aware of information that reasonably suggests that a device has or may have caused or contributed to a serious injury. If the manufacturer is not known, you must submit this report to us. (2) If you are an importer, you must submit MDR reports to: (i) The manufacturer and to us, no later than 30 calendar days after the day that you become aware of information that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or (ii) The manufacturer, no later than 30 days calendar after receiving information that a device you market has malfunctioned and that this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. (3) If you are a manufacturer, you must submit MDR reports to us: (i) No later than 30 calendar days after the day that you become aware of information that reasonably suggests that a device may have caused or contributed to a death or serious injury; or (ii) No later than 30 calendar days after the day that you become aware of information that reasonably suggests a device has malfunctioned and that this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; or (iii) Within 5 work days if required by §803.53. (c) What kind of information reasonably suggests that a reportable event has occurred? (1) Any information, including professional, scientific, or medical facts, observations, or opinions, may reasonably suggest that a device has caused or may have caused or contributed to an MDR reportable event. An MDR reportable event is a death, a serious injury, or, if you are a manufacturer or importer, a malfunction that would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. (2) If you are a user facility, importer, or manufacturer, you do not have to report an adverse event if you have information that would lead a person who is qualified to make a medical judgment reasonably to conclude 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. Persons qualified to make a medical judgment include physicians, nurses, risk managers, and biomedical engineers. You must keep in your MDR event files (described in §803.18) the information that the qualified person used to determine whether or not a device-related event was reportable. (a) The MEDWATCH Medical Device Reporting Code Instruction Manual contains adverse event codes for use with FDA Form 3500A. You may obtain the coding manual from CDRH's Web site at http://www.fda.gov/cdrh/mdr/373.php; and from the Division of Small Manufacturers, International, and Consumer Assistance, Center for Devices and Radiological Health, 1350 Piccard Dr., Rockville, MD 20850, FAX: 301–443–8818, or e-mail to [email protected]. (b) We may sometimes use additional coding of information on the reporting forms or modify the existing codes. If we do make modifications, we will ensure that we make the new coding information available to all reporters. (a) If you become aware of information from multiple sources regarding the same patient and same reportable event, you may submit one medical device report. (b) You are not required to submit a medical device report if: (1) You are a user facility, importer, or manufacturer, and you determine that the information received is erroneous in that a device-related adverse event did not occur. You must retain documentation of these reports in your MDR files for the time periods specified in §803.18. (2) You are a manufacturer or importer and you did not manufacture or import the device about which you have adverse event information. When you receive reportable event information in error, you must forward this information to us with a cover letter explaining that you did not manufacture or import the device in question.
Title 21: Food and Drugs
PART 803—MEDICAL DEVICE REPORTING
Subpart B—Generally Applicable Requirements for Individual Adverse Event Reports
§ 803.20 How do I complete and submit an individual adverse event report?
§ 803.21 Where can I find the reporting codes for adverse events that I use with medical device reports?
§ 803.22 What are the circumstances in which I am not required to file a report?
