BRENTWOOD, Tenn., Oct. 1, 2015 /PRNewswire-iReach/ -- A new FDA regulation that went into effect on May 4th, 2015 has had a significant impact on the entire AED and Manual Defibrillator industry, and DXE has launched an informational series to educate and inform our customers.
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DXE Medical's GM, Matt Spencer, a 16-year veteran of the AED/Defibrillator business, will be addressing this topic in the new PMA Series. We will be taking any questions that you have on the process, so please contact us any time and we'll be glad to help.
For PART 1 of the DXE PMA Series, click here.
Due to the importance of these life-saving devices, all units in the field prior to May 04, 2015 have been "grandfathered" by the FDA, meaning customers may continue using their AEDs that were purchased prior to this date. However, for AEDs that are currently being marketed after the May 5th date, manufacturers needed to have filed an application (or submit an intent to file) for Pre-Market Approval ("PMA") by May 4th, 2015 in order to continue selling these products. To extent "an intent to file" a PMA for a particular model was submitted by the May 4th date, that AED may be sold for another 15 months, at which point the actual PMA needs to be filed with the FDA. The AED can still be sold while the FDA is reviewing the PMA application until an approval or denial letter is issued by the FDA. If a PMA or an intent to file a PMA was not applied for timely, the AED can no longer be sold.
Currently marketed AED accessories were similarly impacted in that manufacturers have sixty (60) months to file PMA in order to continue selling these products. However, an intent to file a PMA is not needed for AED accessories.
Failure to comply with these new PMA regulations can place unnecessary liability on manufacturers, distributions and users of AEDs and related accessories, both from an FDA enforcement and product liability perspective.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.
DXE has an onsite, trained staff to answer any PMA questions on all devices during working business hours. If you do have any questions regarding this topic, or any AED and manual defibrillator topic, please call 866-349-4363 or email CustomerService@DXEMed.com.
DXE Medical, Inc. was founded in 1999. It provides new and premium recertified 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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Media Contact:Justin Darby, DXE Medical Inc, 8663494363, justin@dxemed.com
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SOURCE DXE Medical Inc
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