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U.S. Department of Health and Human Services

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Notice to Industry: FDA Launches Pilot Project for Electronic Submission of Field Alert Reports

FDA is encouraging companies to participate in this voluntary pilot intended to modernize the current method of field alert reporting.
 
The new interactive, electronic version is called Form FDA 3331-Automated. This new form uses Extensible Markup Language (XML) to transition from Adobe PDF to a fully electronic form. Adobe Acrobat Reader allows firms to use this form during the transition to submit the field alert information with traditional e-mail programs, and no additional software or licenses are required. Use of XML enables firms to enter data efficiently and allows the data to be validated at the source, eliminating duplication errors when information has to be re-entered. FDA’s goal is eventually to replace the current paper-based submission procedure. This pilot program is the first step in that direction.
 
Under 21 CFR 314.81(b)(1),companies that manufacture drug products approved under a New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) are required to submit a Field Alert Report (FAR) within 3 days of identifying a problem with the product.
 
A FAR for any distributed drug product must alert the FDA to:
 
  • Any incident that causes the drug product or its labeling to be mistaken for or applied to another article
  • Bacteriological contamination
  • A significant chemical, physical or other change or deterioration
  • Failure to meet the specifications established for the drug in the application
 
All firms—including those who choose to take part in the voluntary pilot program—will still be required to submit a signed FAR.  Companies that elect to use the XML functionality of the new Form FDA 3331-Automated will still be required to submit a signed PDF form by email. 
 
For additional information users can click on this link: PILOT- Form FDA 3331-Automated Pilot Program or contact district field alert monitors [http://www.fda.gov/ICECI/Inspections/IOM/ucm124063.htm