DXE Medical PMA Series – Part 1


FDA’s new stringent evaluation standards are set to improve dependability of AEDs. The goal of this series is to educate customers on the issue.

To learn more about what is being covered in this series, click here.

Q: What is the Pre-Market Approval ruling made by the FDA?

A: The FDA made a final ruling (Section 515(b)(1)(A) of the FD&C Act (21 U.S.C. 360e(b)) in February of 2015 that stated that current and future devices with an AED (Automated External Defibrillator) function would have to go through the more robust Pre-Market Approval (PMA) process to carry the FDA’s approval. The PMA process is the same as what drugs must go through to get approval for use in the U.S. Previously, the FDA allowed these devices to go through a less rigorous process called the 510k. This new process is both time-consuming and expensive, and has caused the manufacturers of existing devices to evaluate whether or not to pursue the PMA for older products that they do not expect to make any longer. Any new products or products currently manufactured MUST go through the PMA process in order to be sold into the U.S. market.

Source: Find more about PMAs from the FDA here.

 Q: Why did the FDA make this ruling?

A: The FDA has been concerned with failure rates of AEDs, and wanted more oversight into the approval process. The purpose is always to protect the U.S. population from unnecessary risk, and make sure that only quality products are being used on people in need.

From the FDA:

“Automated external defibrillators save lives,” said William Maisel, M.D., M.P.H, deputy director for science, chief scientist and acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “These changes to the way these devices are reviewed will allow us to more closely monitor how they are designed and manufactured. This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices.”

Q: What does “PMA” mean and what do the manufacturers have to do to get this approval?

A: PMA stands for “Pre-Market Approval.” Manufacturers of devices or products must submit an adequate amount of information, field studies, patient data, etc. to get this approval. This is why devices are usually launched in countries other than the U.S. first. The product is “tested” in these other countries and the manufacturer uses the data gathered to support making it available in the U.S.

Source: Find more about PMAs from the FDA here.

Models previously sold by DXE Medical that were affected by this new regulation are:

  • Physio-Control Lifepak 500 AED
  • Physio-Control Lifepak 10, 11
  • Philips HeartStart FR2 AED
  • Philips XL
  • Zoll PD1400
  • Zoll M Series monitor/defibrillator
  • Zoll E Series monitor/defibrillator

*For a complete list of affected devices, please contact us.

Trade-In & Trade-Up Program
If you do have an affected device, DXE offers a Trade-In & Trade-Up Program. Right now, if you are ready to trade in your M Series, you can use this trade-in value for a new or recertified Lifepak 12 or Philips HeartStart MRx defibrillator from DXE Medical.

DXE Medical will be sending out a series containing more information regarding the FDA’s recent change in regulations for PMAs on devices with AED functionality. There are many questions that will be answered, but if you have a question you would like us to answer, please submit your questions. If you do have any questions, please call 866-349-4363 or email customerservice@dxemed.com.

DXE Medical, Inc. was founded in 1999. It provides new and refurbished defibrillators, AEDs, EKGs, as well as other medical equipment and has grown to serve customers in all 50 states and 40 countries worldwide. For more information, please visit: http://www.dxemed.com/.

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