• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

Adverse Event Reports - Background

View PDF of the Adverse Event Reports Section (72 KB)


Transparency Report Arrow Background

Summary of Public Comments

Considerations

View All Draft Proposals For This Topic


Background

Mandatory Reporting Requirements Applicable to Drugs and Biological Products
FDA regulations and statutory provisions establish adverse event reporting requirements for human drugs, including biological products, and animal drugs. These requirements apply to responsible persons as defined under each provision—generally manufacturers, packers, or distributors of the products in question, as well as holders of approved premarket applications (new drug applications (NDAs), abbreviated new drug applications (ANDAs), new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and biologics license applications (BLAs)), whether or not they also manufacture, pack or distribute.

Drugs for human use and biological products
In general, manufacturers, packers, distributors and applicants with approved applications for new drugs for human use, manufacturers, packers and distributors of licensed biological products, and persons identified on the label as the manufacturer, packer, or distributor of prescription drugs marketed for human use without an approved application are required to submit postmarketing safety reports of adverse drug experiences to FDA.  A report of each adverse drug experience that is both serious and unexpected must be made to FDA as soon as possible, but no later than 15 days after receiving information about the event.  Persons required to file such 15-day Alert reports are also required to investigate and submit any new information to FDA. 

Applicants with approved applications for new drugs or with biologics licenses must also report certain other adverse events to FDA on a periodic basis.

Nonprescription (OTC) drugs marketed without an approved application are also subject to adverse event reporting requirements, under section 760 of the Federal Food, Drug, and Cosmetic Act.  Manufacturers, packers, or distributors whose name appears on the label of a nonprescription human drug product marketed without an approved application must report serious adverse events associated with their product to FDA within 15 business days.

Animal drugs

For animal drugs, reports of product and manufacturing defects that may result in serious adverse drug events must be submitted by the applicant (or by non-applicant manufacturers, packers, distributors or labelers of the product through the applicant) to the appropriate FDA District Office or resident post within three working days of the company becoming aware that a defect exists.  In addition, a report of each adverse drug event that is both serious and unexpected must be submitted to FDA within 15 working days after the applicant first receives information about the event, no matter what the source of the information.  Applicants must promptly investigate each adverse drug event that is the subject of a 15-day alert report and provide any significant new information about the event to FDA.  Additional drug experience information must be submitted to FDA at periodic intervals—every six months for the first two years following NADA or ANADA approval and yearly thereafter.

Mandatory Medical Device Reporting (MDR) Requirements Applicable to Medical Devices Intended for Human Use
The MDR regulation requires adverse event reporting for manufacturers of medical devices, device user facilities (e.g., hospitals, nursing homes) and importers of medical devices.

Manufacturers of medical devices must submit a report to FDA, no later than 30 calendar days after the day that they receive or otherwise “become aware” of information, from any source, that reasonably suggests that one of their marketed devices (1) may have caused or contributed to a death or serious injury, or (2) has malfunctioned and the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.  Manufacturers of medical devices must also submit a report to FDA no later than five work days after the day that they “become aware” that (1) an MDR reportable event necessitates “remedial action” to prevent an unreasonable risk of substantial harm to public health; or (2) FDA has made a written request for the submission of such a report.

Importers of medical devices must submit MDR reportable events to FDA, with a copy to the manufacturer, as soon as practicable, but no later than 30 calendar days after the day that they receive or otherwise “become aware” of information, from any source, that reasonably suggests that one of their marketed devices may have caused or contributed to a death or serious injury.  Importers must also submit a report to the manufacturer as soon as practicable, but no later than 30 calendar days after the day that they receive or otherwise “become aware” of information, from any source, that reasonably suggests that one of their devices has malfunctioned and that the 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.

Device user facilities, which include hospitals, ambulatory surgical facilities, nursing homes, outpatient diagnostic facilities, or outpatient treatment facilities, which are not a physician’s offices, must also submit adverse event reports.  As soon as practicable, but no more than 10 work days after the day that they “become 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 device user facility, user facilities must submit a report to FDA and to the manufacturer of the device, if known.  User facilities must also submit a report to the manufacturer of the device, if known, and, if the manufacturer is not known, to FDA, no later than 10 work days after the day that they “become 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 in their facility.  Device user facilities are also required to summarize all reportable events that occurred in the facility during the annual reporting year in annual reports submitted to FDA.

Reporting Requirements Applicable to Dietary Supplements
Manufacturers, packers, or distributors whose name appears on the label of a dietary supplement marketed in the United States must report serious adverse events associated with their product to FDA within 15 business days.

Voluntary Reporting
Anyone can submit reports to FDA about adverse events associated with any FDA-regulated products, including foods, drugs and medical devices.  These reports can be submitted in a variety of ways.  Adverse events that occur while using medical products (excluding vaccines), conventional foods and dietary supplements, cosmetics, and infant formula can be reported to the Agency’s MedWatch program.  Anyone may report vaccine-related illness or injury to the Vaccine Adverse Event Reporting System (VAERS). 

Although FDA requests detailed information about the product and its usage in order to better characterize the adverse event and determine the likelihood it may be caused by the product, adverse event reports vary in the amount of information that can be provided or is known.

In some cases, FDA provides a mechanism for the public to quickly access information from adverse event reports submitted to FDA. 

  • The Agency’s Adverse Event Reporting System (AERS) collects information about adverse events, medication errors and product problems that occur after the administration of approved drug and therapeutic biological products.  Individuals familiar with the creation of relational databases can download quarterly (noncumulative) data files from the AERS Web site, including, among other things, the trade name and/or established name of the product, dosage, route of administration, the adverse event, and the health outcome. 
  • Information about human vaccine adverse events is available online through the Vaccine Adverse Event Reporting System (VAERS). VAERS collects information about adverse events that occur after the administration of vaccines licensed for use in the United States.  Public VAERS records include, among other things, the vaccine, dosage, route of administration, the adverse event (including a narrative description), and the health outcome.
  • Information about medical device adverse event reports is available online through the Manufacturer and User Facility Device Experience (MAUDE) database.  Users can search the database for information on medical devices that may have malfunctioned or caused death or serious injury.  Public MAUDE reports include, among other things, the trade name and/or established name of the product, the adverse event (including a narrative description), and the health outcome.

In addition, in some cases, the Agency alerts the public to new information about serious adverse events when it issues communications about an emerging safety issue.