What are the voluntary and mandatory reporting options under MedWatch?
The U.S. Food and Drug Administration’s (FDA) MedWatch initiative is designed to ensure the safety of drugs, biologics, medical devices and other products regulated by FDA. The information provided here is limited to medical device reporting under MedWatch.

FDA’s voluntary reporting form (Form 3500) is used by healthcare professionals and others to report serious adverse events, product quality problems, and instances of product user error associated with FDA-regulated products. The MedWatch mandatory reporting form (Form 3500A) is used by device user facilities, distributors, and manufacturers to submit reports of device-related deaths, serious injuries, and serious illnesses. Facilities must report all suspected medical -device-related deaths to both FDA and the product’s manufacturer, if known. Reports of serious injuries should be submitted to the product’s manufacturer or, if the manufacturer is unknown, to FDA, These reports, as shown in the table below, must be submitted on the MedWatch 3500A mandatory reporting form.

Requirements for Mandatory Reporting of Device-Related Incidents (MedWatch Form 3500A)

Can I still report device-related incidents to ECRI Institute?
ECRI Institute’s decision to discontinue its Computerized Problem Reporting System for submitting MedWatch reports will have no effect on ECRI Institute’s Problem Reporting Network (PRN), a voluntary program through which healthcare providers, patients, and manufacturers can confidentially report medical-device-related incidents and deficiencies to us. As we have for the past 40 years, we will gather and investigate reports of incidents involving medical devices (including capital equipment, reusable and disposable instruments, and reagents) to help improve patient care and inform purchase decisions. You can submit PRN reports online or you can download and complete a copy of our PRN form and mail or fax it to ECRI Institute.

Please fax or mail your report to: 

ECRI Institute
5200 Butler Pike
Plymouth Meeting PA, 19462-1298, USA
Fax: (610) 834-1275

Where can I get copies of the MedWatch forms?
Both forms are available for download from FDA’s Web site. Instructions for completing the voluntary and mandatory reporting forms are posted with the forms.

Remember to use the appropriate form depending on whether you are completing a voluntary or mandatory report. Form 3500 is used for voluntary reports of serious adverse events associated with FDA-regulated products. 

Healthcare providers must use Form 3500A, the mandatory-report form, to report device-related deaths, serious injuries, and serious illnesses.

Can I submit MedWatch forms online?
The voluntary reporting form (3500) may be submitted to FDA electronically; no such option exists for the mandatory reporting forms.

FDA also provides software for installing a version of the 3500 and 3500A that may be filled using a computer, but the user must still print and mail or fax the form after completing it. The software may be downloaded  from FDA’s Web site.

FDA does allow facilities to submit a computer-generated facsimile of the 3500A form. Facilities must obtain written approval from FDA to use this approach. Instructions for preparing a facsimile of form 3500A are provided in FDA’s “Instructions for Completing the MedWatch Form 3500A.”

Where should I send the forms?
Mandatory reporting forms. Healthcare facilities must submit a mandatory reporting (3500A) form to FDA and the manufacturer if the incident involves a death or, in the case of serious injuries, if the manufacturer is not known. Mandatory reporting forms for device-related information can be submitted to FDA at the following address by standard mail:

MDR Reporting
Center for Devices and Radiological Health
Food and Drug Administration
P.O. Box 3002
Rockville, MD 20847-3002

If the forms are sent by a courier service, use the following address:

CDRH–Mandatory Device Reporting
1350 Piccard Drive
Rockville, MD 20850

The envelope containing reports submitted to FDA must be identified as such. FDA suggests marking the envelope with the words “User Facility Report.”

Healthcare providers can also fax the mandatory reporting form to FDA. The agency asks that you call the agency’s data entry staff at (240) 276-3000 when you wish to fax the report. The staff will provide a fax number for submitting the report.

The hospital materials management department can help identify the address for the manufacturer of the product involved.

Voluntary reporting forms. FDA’s voluntary reporting (3500) form is ready to mail to FDA and does not require a stamp. Just follow the folding and taping instructions provided on the form. It should be mailed to the following address:

MedWatch
FDA Safety Information and Adverse Event Reporting Program
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20852-9787

Healthcare providers can also fax the voluntary reporting form to FDA at (800) FDA-0178.

What is the annual summary form?
Under the medical device reporting requirements of the SMDA, user facilities must submit an annual summary report to FDA of all adverse events reported to manufacturers or FDA during a designated reporting period. The information is submitted on Form 3419. The annual report must be submitted by January 1 and include events that were reported between January 1 through December 31 of the previous year.

If no mandatory medical device reports were submitted in the previous year, an annual report does not need to be submitted.

Where can I get copies of the annual summary form?

The annual report form (Form 3419) is available for download from FDA’s Web site.  Instructions for completing the form are available online.

Do I need to include copies of the mandatory MedWatch report (Form 3500A) with the annual summary?
FDA wants information that is already on the 3500A form. The most efficient approach, therefore, is for reporting facilities to attach a copy of each 3500A form to the annual summary. Alternatively, you can provide a summary of each event by completing Part 2 of Form 3419 for each event.

Where should I send the annual summary?
Use the same address that you use for submitting mandatory MedWatch reports of device-related information to FDA. The mailing address is as follows:

MDR Reporting
Center for Devices and Radiological Health
Food and Drug Administration
P.O. Box 3002
Rockville, MD 20847-3002

Remember to clearly identify the envelope containing the annual summary. FDA suggests marking the envelope with the words “User Facility Annual Report.”

Can I submit the annual summary online?
No.

I have questions about medical device reporting. Where can I go for help?
ECRI Institute’s problem reporting and risk management staff are available to answer questions from subscribers to its membership programs. Contact us at problemreport@ecri.org or hrc@ecri.org.

Facilities can also contact FDA staff with questions about medical device reporting, including those regarding interpretation of policy, by mail, telephone, or fax. The table below lists FDA’s contact information for help on medical device reporting.