FDA’s new stringent evaluation standards are set to improve dependability of automated external defibrillators (AEDs).
This is part 2 of the DXE Medical PMA Series regarding important information you should know about the FDA’s recent change in regulations on AED Pre-Market Approval (PMA) requirements.
Q: Does the FDA’s ruling apply to only AEDs or also to manual defibrillators with an AED function?
A: As several manufacturers and numerous other resources (FDA agents and attorneys) read the ruling, the PMA requirement DOES apply to both AEDs and manual defibrillators with an AED function.
Source: Please refer to page 7 of the FDA Transcript of the final hearing here. When asked about additional function assessments other than AED function, the FDA representative states:
“Certainly for the AED functions they need to have a reasonable assurance of safety and effectiveness, but we would not expect any change to the – say monitoring functions or the ECG functions that currently exist on some of the monitor defibrillators.”
Q: When do the manufacturers have to complete the PMA?
A: All manufacturers of devices, parts and accessories were given until May 4th, 2015 to present their “intent” to file the PMA. The intent to file is only to notify the FDA that the manufacturer plans on pursuing the PMA process. Once the intent to file has been received by the FDA, the manufacturer has until August of 2016 to complete the PMA process for approval by the FDA.
Source: Please refer to page 4 of the FDA Transcript of the final hearing here.
Q: What happens while the manufacturers are pursing the PMA process?
A: In short, nothing. The device is still covered by the prior 510k and is approved for use until August 2016, when the file period expires.
Source: Please refer to page 5 of the FDA Transcript of the final hearing here.
Q: What does a FDA “class change” mean?
A: The FDA moved AEDs and defibrillators with an AED function on them to a Class III device, from a Class II. Class III devices differ from Class II devices in that they deliver a therapy or a drug. The FDA has decided that AEDs do deliver therapy; therefore, as Class III devices, they must go through a more rigorous approval process.
Source: From the FDA:
“The Food and Drug Administration Safety and Innovation Act calls for the FDA to publish proposed and final orders to reclassify or call for PMAs for pre-amendments devices.”
Q: Which devices sold by DXE Medical are affected?
A: Models previously sold by DXE Medical that are 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 DXE Medical at 866-349-4363 or email CustomerService@DXEMed.com.
About the DXE Medical PMA Series:
The DXE Medical PMA Series contains pertinent information regarding the FDA’s recent change in regulations for PMAs on devices with AED functionality. This series will answer many questions, but if you have an immediate question you would like us to answer, please call 866-349-4363 or email email@example.com. To view previous PMA Series releases:
- Introduction: http://www.ireachcontent.com/news-releases/fda-sets-new-regulations-affecting-entire-aed-market-530233411.html
- Part 1: http://www.dxemed.com/blog/dxe-medical-pma-series-part-1/
About DXE Medical:
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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