FDA Proposes Mandatory Electronic Safety Reporting

The U.S. Food and Drug Administration is proposing to amend postmarket safety reporting regulations for three of its centers to require that manufacturers and other facilities subject to current reporting requirements submit their reports in an electronic format. The agency issued two proposed rules on Friday--one that applies to electronic medical device adverse event reporting and one that applies to electronic drug and biologic product adverse experience reporting. The rules would not change what types of incidents are required to be reported to the FDA, but they would require that the incidents be reported in an electronic format that the FDA can process, review, and archive.

“Both proposed rules will improve the agency’s ability to obtain safety information more quickly, which will help lead to faster identification of potential safety problems,” said David Buckles, Ph.D., director of the Division of Postmarket Surveillance at the FDA’s Center for Devices and Radiological Health (CDRH). “Information obtained from these reports may be critical to future action that improves patient safety.”

Currently, CDRH receives most mandatory medical device adverse event reports on paper, which requires that reports are manually entered into the center’s adverse event database, called the Manufacturer and User Facility Device Experience (MAUDE) database, for further analysis. Not only is this step costly, but it hinders CDRH’s ability to review safety data quickly to uncover potential public health problems.

The proposed regulation for medical devices would require manufacturers, importers, and user facilities to submit reports to the FDA in electronic format, which will be loaded into the MAUDE database.

The electronic medical device reporting system, known as eMDR, provides a choice of two electronic options for reporting postmarket safety information. Small manufacturers with a limited number of reports may prefer an application known as eSub, which runs on free software available from the FDA. Large manufacturers, which can submit hundreds of reports per year, may prefer to use a batch submission protocol, based on a widely recognized informatics standard.

The FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) currently receive adverse event reports on paper forms or electronically. Safety reporting data submitted on paper forms must be manually entered into the FDA’s Adverse Event Reporting System (AERS) before these data can be evaluated. Since 2000, CDER and CBER have allowed manufacturers (through a pilot program and FDA guidance) to submit adverse event reports electronically, which get quickly entered into AERS. This pilot program has enabled FDA staff to more rapidly review postmarketing safety data and identify emerging safety problems. Safety reports in electronic format can currently be submitted to the FDA either through the FDA’s Electronic Submission Gateway or on CD-ROM, digital tape, or floppy disk. International Conference on Harmonization (ICH) standards for data elements and technical specifications are used for these electronic submissions.

The proposed rule for drugs and biologics reporting would require manufacturers, packers, and distributors to submit reports to the FDA in electronic format, which will eliminate manual processing of paper forms by both manufacturers and the FDA. Reports will be submitted to the FDA using either the ICH electronic standards or through an FDA safety reporting Web portal that is currently under development.

“Electronic reporting of serious and unexpected adverse experiences will reduce industry costs and encourage better communication with the FDA and other regulators,” said Gerald J. Dal Pan, M.D., director of CDER’s Office of Surveillance and Epidemiology.

The proposed rule for drugs and biologics reporting does not, however, apply to safety reports filed under an investigational new drug application, annual reports that manufacturers submit to the FDA on approved drugs and biologics, biologic product deviation reports, reports of complications of blood transfusion and collection confirmed to be fatal, and certain reports on human cells, tissues, and cellular and tissue-based products.

The proposed rule for medical devices does not apply to reports submitted on a voluntary basis, FDA noted.

Manufacturers submitting reports under either rule would be required to obtain an electronic certificate to use the FDA Electronic Submissions Gateway. Information on how to prepare and send postmarket safety reports for devices and for drugs and biologics is contained in draft guidance documents. Draft guidance for device reports is now available. The draft guidance for drug and biological product reports has been available since June 2008.

To access FDA’s Web site on Electronic Medical Device Reporting, visit www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm. For FDA’s Web site on the FDA eSubmitter, go to www.fda.gov/ForIndustry/FDAeSubmitter/default.htm.

Download Center

  • Safety Metrics Guide

    Is your company leveraging its safety data and analytics to maintain a safe workplace? With so much data available, where do you start? This downloadable guide will give you insight on helpful key performance indicators (KPIs) you should track for your safety program.

  • Job Hazard Analysis Guide

    This guide includes details on how to conduct a thorough Job Hazard Analysis, and it's based directly on an OSHA publication for conducting JHAs. Learn how to identify potential hazards associated with each task of a job and set controls to mitigate hazard risks.

  • A Guide to Practicing “New Safety”

    Learn from safety professionals from around the world as they share their perspectives on various “new views” of safety, including Safety Differently, Safety-II, No Safety, Human and Organizational Performance (HOP), Resilience Engineering, and more in this helpful guide.

  • Lone Worker Safety Guide

    As organizations digitalize and remote operations become more commonplace, the number of lone workers is on the rise. These employees are at increased risk for unaddressed workplace accidents or emergencies. This guide was created to help employers better understand common lone worker risks and solutions for lone worker risk mitigation and incident prevention.

  • EHS Software Buyer's Guide

    Learn the keys to staying organized, staying sharp, and staying one step ahead on all things safety. This buyer’s guide is designed for you to use in your search for the safety management solution that best suits your company’s needs.

  • Vector Solutions

Featured Whitepaper

OH&S Digital Edition

  • OHS Magazine Digital Edition - May 2022

    May 2022

    Featuring:

    • WEARABLE TECHNOLOGY
      How Wearable Technology is Transforming Safety and the Industrial Workplace
    • TRAINING: CONFINED SPACES
      Five Tips to Improve Safety in Confined Spaces
    • INDUSTRIAL HYGIENE
      Monitor for Asbestos to Help Save Lives
    • PPE: FALL PROTECTION
      Fall Protection Can Be Surprising
    View This Issue