FDA Proposes Expedited Medical Device Access Program

The agency proposes a new expedited access program for medical devices for patients whose conditions are urgent and serious.

The FDA has proposed a new, expedited access program for medical devices that would give patients with serious conditions earlier access to high-risk medical devices. The proposed program—the Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions (EAP)—is designed for patients whose needs are unmet by current technology, the FDA reports.

The program "features earlier and more interactive engagement with FDA staff—including  the involvement of senior management and a collaboratively developed plan for collecting the scientific and clinical data to support approval—features that, taken together, should provide these patients with earlier access to safe and effective medical devices," according to FDA.

To be eligible for participation in the program, a medical device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease, have an acceptable data development plan, and represent one of the following:

     1. No approved alternative treatment/diagnostic exists, or
     2. A breakthrough technology that provides a clinically meaningful advantage over existing technology, or 
     3. Offers a significant, clinically meaningful advantage over existing approved alternatives, or 
     4. Availability is in the patient's best interest  

"We are excited to offer a proposed program for expedited access for certain high-risk medical devices," said Dr. Jeffrey Shuren, M.D., director of FDA's Center for Devices and Radiological Health. "The program allows manufacturers to engage early and often with the agency. We expect most devices that enter this program will be in the pre-clinical trial phase."

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 - June 2022

    June 2022

    Featuring:

    • SAFETY CULTURE
      Corporate Safety Culture Is Workplace Culture
    • HEAT STRESS
      Keeping Workers Safe from Heat-Related Illnesses & Injuries
    • EMPLOYEE HEALTH SCREENING
      Should Employers Consider Oral Fluid Drug Testing?
    • PPE FOR WOMEN
      Addressing Physical Differences
    View This Issue