• Regulatory NewsRegulatory News

    FDA to Soon Require Medical Device Companies to Submit Adverse Event Data Electronically

    The US Food and Drug Administration (FDA) is reminding manufacturers and importers of medical devices about an upcoming requirement to submit all adverse event reports electronically. Background The shift was made final in February 2014 under a final rule, Medical Device Reporting: Electronic Submission Requirements . While medical device manufacturers have long been required under 21 CFR 803 to report known or suspected adverse events to FDA, the regulator has tra...
  • Regulatory NewsRegulatory News

    US FDA Proposes Changes to MedWatch Program for Healthcare Products

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. US drug and medical device market regulators are proposing changes to voluntary and mandatory post-market reporting forms used by consumers and healthcare providers for adverse events related to medical products. The Food and Drug Administration is seeking comment through July 1, 2015 on  changes  to three reporting components of its MedW...
  • Regulatory NewsRegulatory News

    FDA Proposes Changes to its Adverse Event Reporting Forms

    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. Background 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 ...