FDA Proposes Changes to its Adverse Event Reporting Forms

Regulatory NewsRegulatory News | 11 December 2014 |  By 

The US Food and Drug Administration (FDA) is proposing several changes to its adverse event reporting forms, known within the industry as Forms 3500, 3500A and 3500B.


FDA has three adverse event reporting forms it uses to collect information about medical products, including drugs (prescription and non-prescription), biologics, medical devices and dietary supplements.

  • Form 3500, which healthcare providers can use to report information on a voluntary basis
  • Form 3500A, which medical product manufacturers and some facilities are required to use when they are made aware of adverse events involving their product or facility
  • Form 3500B, a voluntary, consumer-friendly reporting form

The most recent of those forms, 3500B, was only launched by FDA in June 2013 as a way to get patients more involved in the regulatory process. However, FDA only permits this form to be submitted by mail or fax, presumably to cut down on malicious or frivolous reporting.

To learn more about FDA's consumer-friendly adverse event reporting form 3500B, please see our June 2013 article, "New Medwatch Form Geared Toward Simple Adverse Event Reporting for Consumers."

Changes Proposed

Now in a new Federal Register announcement, FDA says it wants to make some changes to all three versions of its Form 3500 in the hopes of bringing the forms "into conformation … with current regulations, rules and guidances."

The changes are mostly intended to add clarity to the forms. For example, FDA proposes changing all three forms to include checkboxes for years, months, weeks and days—a helpful addition if a patient was an infant. Another proposed addition would allow patients to input their weight in either pounds or kilograms—helpful for patients who may not be familiar with the US system of weights and measurements. The date field would also be changed to a format of DD-MM-YYYY to clarify exactly how the date should be formatted.

FDA said these changes would make it easier to scan in forms using optical character recognition software, decreasing the burden on staff.

FDA also said it wants to use a new "race and ethnicity" field to allow for the selection of multiple races—useful information since different races can sometimes be affected by drugs in different ways.

FDA's form will also now apply to compounded pharmaceutical products as well, and will contain a prompt to include data about the "manufacturer/compounder" and the lot number, if applicable.


Federal Register Announcement


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