This month the FDA posted a notice on updates to the forms for reporting adverse events related to medical products (either drugs or devices) to the agency. Manufacturers and compounders have a regulatory mandate to report serious adverse events and they use form 3500A for that purpose. Form 3500 is for voluntary reports by healthcare professionals. The agency has received comments that this voluntary reporting program be better advertised to healthcare professionals, which I support. However, we don’t have to rely on our healthcare professionals to report any problems we experience with medical products, because the agency has a separate form (and program, called FDA MedWatch) for voluntary consumer reporting. The form is written in plain language and can be used by any person (patient or caregiver) wishing to report a problem with their medical product. The online version of the form may be found here, and that page includes instructions and links for report problems with products not covered by MedWatch (such as tobacco products or vaccines). For those preferring to mail or fax their reports, the link to a fillable PDF form (which includes instructions) may be found here.

Text Copyright © 2018 Katrina Rogers