Updated FDA Requirements for AED Systems

Updated FDA Requirements for AED Systems

fdaEffective on February 3, 2015 the Food and Drug Administration issued a final order requiring premarket approval applications (PMA) to be filed for automated external defibrillator (AED) systems and accessories (such as pad electrodes, batteries, and adapters). This order was prompted by safety concerns that arose from MDR adverse events and AED device recalls. The FDA determined that AED systems require increased regulatory oversight, and so AED have been classified as class III devices that require premarket approval in order to be marketed or distributed.

Overview of Final Order

  • For both new devices and accessories, if a 510(k) clearance was not issued, a PMA approval must be received before the device (or accessory) can be marketed.
  • Currently Marketed Devices can continue to be distributed; however an “Intent to File” must be submitted to the FDA 90 days from the date of the final order (Monday May 4, 2015).
    • Intent to file should include list of all devices for which PMA approval will be sought.
    • If Intent to File is submitted, distribution can continue until a PMA is submitted, but no longer than 18 months from date of the final order.
    • If Intent to File is not submitted, distribution must cease 90 days from the date of the final order.
    • Multiple “Public Access” or “Professional” devices can be included in a single PMA. Accessories can also be included in the PMA.
    • If Intent to file is not received with 90 days, or if the PMA is not approved, the manufacturer must cease distribution or they will be subject to seizure and condemnation.
  • Intent to file is not required for Currently Marketed AED Accessories. However:
    • If accessory is not included in the AED Device PMA, a separate PMA must be submitted within 5 years (60 months) from the date of final order.
    • If accessory is included in the PMA, distribution can continue unless a not approvable or a denial decision is issued.

Boston Biomedical Associates’ Role:

  • Intent’s to File are due to the FDA on May 4, 2015 and PMA’s are due August 3, 2016. This leaves little time to gather resources and information.
  • Boston Biomedical Associates offers the following services to ensure that your device can meet the premarket approval requirements ahead of the August 3, 2016 deadline.
    • Submission of FDA Pre-Submissions to gather input from the agency
    • Oversight of each PMA module preparation and submission
    • Modular PMA writing
    • Working with internal stakeholders to aid in PMA compilation
    • Project Management for all aspects of PMA Readiness
    • Management of FDA correspondence.
    • Data Management and statistical analyses for clinical reports
    • If the clinical data is scarce, we offer the expertise to demonstrate that your device is safe and effective.
      • This includes study design and execution of all aspects of clinical studies, if required, to support your PMA
    • QSIT GMP Mock Audit preparation
    • BIMO Mock Audit preparation

For information on how we can help or to speak to one of our regulatory experts, please contact Mack Rubley, Vice President Consulting Services at 508-351-8632 ext. 245 or at mrubley@boston-biomedical.com.

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Mack Rubley
mrubley@boston-biomedical.com

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