Coalition Comments on Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System

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Division of Dockets Management
Food and Drug Administration
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Comments of the Patient, Consumer, and Public Health Coalition on Proposed Order “Effective Date of Requirement for Premarket Approval for Automated External Defibrillator System”

[Docket No. FDA-2013-N-0234]

As members of the Patient, Consumer, and Public Health Coalition, we strongly support the FDA proposed order that will require the premarket approval application (PMA) for Automated External Defibrillators systems (AEDs).  However, we oppose the FDA exercising an enforcement discretion that would allow 510(k) cleared AEDs to remain on the market for 15 months after FDA issues a final order requiring a PMA for these devices.

Automated External Defibrillators Should Require PMAS

We strongly agree with the 2011 FDA Panel that stated “because AEDs are lifesaving devices it is appropriate to regulate them in class III.”^[1]  More than 350,000 Americans will collapse from sudden cardiac arrest this year.^[2]  For many of these men and women, their “survival depends upon a rapid sequence of rescue events that includes the successful delivery of a defibrillation shock from an AED. Rescuers have only minutes before these patients’ heart rhythms degenerate beyond rescue capabilities.”^[1]  In other words, if an AED is working, it can save a life.  If it doesn’t work correctly, the person is likely to die.

FDA’s presentation to the 2011 Panel noted that the number of adverse reaction reports for AEDs more than doubled from 2005 to 2010.^[1]  We have reviewed the data on the FDA web site and note that the numbers have continued to increase in 2011 and 2012.  During the period from January 1, 2005 to March 31, 2010, there were 23,591 Medical Device Reports (MDRs) including 721 deaths.^[3]  Researchers have reported that more than 20 percent of the nearly one million AEDs in circulation were recalled by the FDA.^[4]

A study of high-risk recalls of medical devices from 2005-2009, Medical Device Recalls and the FDA Approval Process, published in the Archives of Internal Medicine in 2011, noted that cardiovascular devices comprised the largest category of high-risk recalls.^[5]  Eleven out of the 13 high-risk cardiovascular recalls for devices that had been cleared by the 510(k) process were for AED devices.

Most members of the FDA’s 2011 Panel recommended the “reconfirmation of AEDs as class III devices” and “expressed significant concerns” that the increase in recalls and adverse events indicate that the 510(k) process “has not been successful” and increased regulatory oversight is needed.^[1]  Although the AED manufacturers who were present at the public meeting disagreed and stated that this would stifle innovation, they were unable to provide a single example of an improved AED that was delayed from reaching the market because of FDA regulatory policies.

Exercising Enforcement Discretion

Preamendments class III AED devices may be commercially distributed without a PMA until 90 days after FDA issues a final order.  AED manufacturers have known for many years that Congress had passed laws forbidding the continued use of the 510(k) review process for a Class III device.  They have known since 2011 that the FDA’s advisory panel recommended that AEDs remain as Class III devices subject to PMA.  This provided ample time to prepare PMA applications.  Given the large number of deaths from defective AEDs and the large number of recalled AEDs, there is no reason to continue to allow AEDs of unproven safety and effectiveness to remain on the market without enforcement for 15 months from the date the final order is issued.  The FDA’s justification, the “widespread distribution of AEDs”^[1] is baffling.  FDA has stated that “most AED manufacturers already have the clinical data they need to support a PMA.”^[1] Nonetheless, because FDA recognizes that the continued access to AEDs is important to the public health, FDA is proposing to consider exercising enforcement discretion.”  We disagree strongly with that analysis.

Access to AEDs that function properly is important to public health, not access to defective AEDs. Since the FDA admits that only “a small number of manufacturers may need to conduct additional investigations to support approval,”^[1] there is no reason to believe that there would be a shortage of PMA-approved AEDs available to the public.  FDA should not exercise enforcement discretion under these circumstances, since there is no public health need and a delay sets a terrible precedent that could endanger patients.  FDA should enforce the PMA requirement 90 days after the final order.

Conclusion

We support FDA’s proposed order to require PMAs for Automated External Defibrillators systems. AEDs must be class III PMA devices because the lives of men and women depend on the effectiveness of these devices.  When they do not work, people have died.  The PMA process will reduce the number of defective AEDs by adding rigor to the review process, including better clinical data, pre-market inspections, and post-market studies.   The law specifies PMAs for class III devices for a reason—to protect patients.  More than 350,000 Americans may need an AED this year, which is why we do not support the FDA exercising enforcement discretion for 15 months.

American Medical Student Association
Center for Medical Consumers
Consumers Union
National Research Center for Women & Families
National Women’s Health Network
Center for Science and Democracy, Union of Concerned Scientists
U.S. PIRG
WoodyMatters

For more information, contact Paul Brown at (202) 223-4000 or at pb@center4research.org