Free Shipping on Orders over 99!
Contact Support 888-652-1882
Shop By

FDA Pre-Market Approval (PMA)

FDA Pre-Market Approval (PMA)

Our FDA Pre-Market Approval (PMA) page offers vital insights into the FDA's approval process for Class III medical devices, including AEDs. We delve into the significance of the FDA's 2015 final order and its impact on AED manufacturers. The page guides users on verifying the FDA approval status of their AED models and provides advice on transitioning to compliant devices. This information is essential for adhering to FDA regulations and ensuring the use of safe, effective AEDs.



Have Question? Contact Us


Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. 


The FDA published a final order in 2015 requiring premarket approval applications for new and existing AEDs and accessories. All AEDs must go through the FDA’s PMA process in order to be approved for sale in the US.


In 2019, the FDA notified AED manufacturers who did not submit a PMA application for their AEDs, that they are no longer allowed to market their AED. It was also stated that by February 3, 2020*, manufacturers of accessories (such as batteries, pad electrodes, adapters and hardware) for FDA-approved AEDs, are required to file a premarket approval application. If a PMA is not filed by then, the manufacturer must cease marketing and can no longer support these accessories effective February 2022. This deadline also applies to accessories intended for AEDs that are not FDA-approved. 


To ensure your device is approved by the FDA, check for your model on the table below. If it is not on the list, contact us today for more information on how we can assist you in transitioning to a premarket approved device and how you can earn up to $625 through our trade-in program. 


The Following AEDs are no longer supported by the FDA (as of Feb 3, 2022)

  • Welch Allyn AED 10
  • Welch Allyn AED 20
  • Lifepak 500
  • HeartSine 300
  • HeartSine 300P
  • Philips FR2
  • Philips Forerunner
  • Burdick First Save Model 92531
  • Burdick Cardiovive AT AED Model 92532
  • Burdick Cardiovive DM Model 92533
  • Cardiac Science Powerheart AED Model 9300E-0xx
  • Cardiac Science Powerheart AED Model 9300E-1xx
  • Cardiac Science Powerheart AED Model 9300A-2xx
  • Cardiac Science Powerheart AED Model 9300E-2xx
  • Cardiac Science Powerheart AED Model 9300P-2x
  • Cardiac Science Firstsave Model 9300C-xxx
  • Cardiac Science Firstsave Powerheart Model 9300D-xxx


The Following Manual Defibrillators are no longer supported by the FDA (as of Feb 3, 2022)

  • Philips MRx
  • ZOLL M Series
  • Lifepak 12

*FDA deadline moved to February 3, 2022: "The FDA has since issued a guidance to revise its compliance policy regarding the deadline for filing PMAs for these necessary AED accessories, announcing that the FDA does not intend to enforce compliance with the PMA submission requirement for these necessary accessories until February 3, 2022. This revised compliance policy  allows facilities additional time, particularly during the COVID-19 pandemic, to procure FDA-approved AEDs and manufacturers to file the required PMA for necessary accessories, respectively."