Reporting Adverse Events: FDA Seeks Comments on Revisions to Submission Forms

Regulatory NewsRegulatory News | 15 March 2018 |  By 

FDA on Thursday sought comments on modifications and revisions the agency is planning to make to the forms used by health professionals, drugmakers and hospitals to report adverse events.

The proposed modifications would align the forms with current regulations, rules and guidance, while formatting modifications are being proposed to enhance the “quality, utility, and clarity of the information” in them and proposed extensions “will only have changes in the form instructions to provide clarity of reporting,” FDA said in a Federal Register notice.


The agency currently uses three different forms:
  • Form FDA 3500, which is intended to be used for voluntary (i.e., not mandated by law or regulation) reporting by healthcare professionals on serious adverse events, product problems and product use errors and therapeutic failures
  • Form FDA 3500B, which is written in plain language and is intended to be used for voluntary reporting by consumers, patients and their caregivers
  • Form FDA 3500A, which is used for mandatory reporting (i.e., required by law or regulation).
“When FDA receives this information from healthcare professionals, patients, or consumers, the report becomes data that will be used to assess and evaluate the risk associated with the product,” the agency said. “FDA will then take whatever action is necessary to reduce, mitigate, or eliminate the public's exposure to the risk through regulatory and public health interventions.”

The agency also noted that hospitals are not required by federal law or regulation to submit reports associated with drugs, biologics or special nutritional products. However, hospitals and other user facilities are required by federal law to report medical device-related deaths and serious injuries.

The Medical Device User Fee and Modernization Act of 2002 required FDA to revise the forms, known as MedWatch forms, to better report information on reprocessed single-use devices, including the name of the reprocessor and whether the device has been reused.


As far as comments, FDA said it would like to know: “(1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.”

The agency also said it welcomes comments on translating the consumer form, Form FDA 3500B, into Spanish and other languages.
 Federal Register


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy