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FDA Down-Classifies External Pacemaker Pulse Generator Devices and PSAs

Posted 15 April 2016 | By Zachary Brennan 

FDA Down-Classifies External Pacemaker Pulse Generator Devices and PSAs

The Food and Drug Administration (FDA) on Friday released a final order to reclassify external pacemaker pulse generator (EPPG) devices and pacing system analyzers (PSAs), which are currently class III devices, into class II (special controls).

The final order also creates a separate classification regulation for PSAs and places single- and dual-chamber PSAs, which are currently classified with EPPG devices, and triple-chamber PSAs (TCPSAs), which are currently post-amendments class III devices, into that new classification regulation. FDA is also making a slight modification to identify EPPG devices as prescription devices.


On 17 October 2011, FDA first published a proposed rule calling for the down-classification of EPPG devices from class III to class II, but that proposal was withdrawn in September 2014 because of the authorization of the Food and Drug Administration Safety and Innovation Act (FDASIA), as well as new information discussed during an FDA advisory meeting.

In describing the idea for the down-classification, FDA says: “Single and dual chamber PSAs have historically been classified with EPPG devices. Single and dual chamber PSAs combine the functionality of a single or dual chamber EPPG, which is currently a class III device, and the functionality of a pacemaker electrode function tester, which is regulated as a class II device under § 870.3720 (21 CFR 870.3720). Single and dual chamber PSA devices have been found substantially equivalent to EPPG devices through the 510(k) process.”

TCPSA devices, however, have not been determined to be substantially equivalent to a predicate device through the 510(k) process and, because TCPSAs were not marketed before 28 May 1976, they have been reviewed through the PMA process as class III devices.

Safety Panel

In 2013, a panel of medical experts supported the reclassification of EPPG and PSA devices.

“The 2013 Panel recommended that EPPG devices (including single and dual chamber PSAs) be reclassified to class II with special controls when intended for cardiac rate control or prophylactic arrhythmia prevention,” the final order says. The panel’s rationale for the EPPG device reclassification was based on the proposed special controls FDA presented, which the 2013 panel “believed were adequate (along with general controls) to mitigate the risks of the device.”

The 2013 panel also recommended that TCPSA devices be reclassified to class II with special controls when intended for use during the pulse generator implant procedure.

The decision for the TCPSA device reclassification was based on: “(1) These devices are used only during the implant procedure where backup monitoring is continuous, hazards can be recognized and treated immediately, and where there is a reasonable expectation that users are adequately trained; (2) these devices are not intended to provide the long-term hemodynamic benefit of biventricular pacing or cardiac resynchronization therapy; and (3) the recommended special controls will mitigate the health risks associated with the device.”

Here are the 11 September 2013 panel transcript and other meeting materials.

“Since the 2013 Panel meeting, FDA has not become aware of new information that would provide a basis for a device classification panel to make a different recommendation or different findings,” FDA says.

Public Comment

In response to the proposed order from 2014, FDA received two comments and responded to those, in addition to three sets of other comments from the October 2011 proposed rule that was withdrawn.

“Four comments suggested that EPPG devices are life-sustaining and should be subject to premarket approval to provide better assurance of safety and effectiveness; as such, the comments asserted that EPPG devices should remain in class III. Further, one comment indicated that the proposed special controls are not sufficient to mitigate the risks associated with EPPG devices,” FDA says. “Three other comments also discussed the risks associated with these devices and the need for adequate mitigation through premarket approval.”

In response, FDA says it “has concluded that for EPPG devices, special controls will provide reasonable assurance of safety and effectiveness to appropriately mitigate risks to health. Therefore, these life-supporting devices can be reclassified into class II.”

Three comments referenced the number of medical device reports (MDRs) associated with EPPG devices and suggested that MDR data support keeping EPPG devices in class III. Two of those comments also discussed the number of MDR reports for malfunctions associated with EPPG devices and suggested that this shows the performance standards that have been developed and used to support EPPG marketing applications are insufficient to provide reasonable assurance of safety and effectiveness, FDA says.

The agency, however, said that increased premarket regulatory requirements cannot be assumed to result in fewer MDRs, nor are MDRs necessarily an indicator of poor device performance.

FDA also said it performed “multiple analyses of MDRs for EPPG devices in the Manufacturer and User Facility Device Experience (MAUDE) database. The Agency’s analysis of the available data shows that over 85 percent of reports had either no patient involvement or no known consequences to the patient. These types of malfunction reports were generally discovered during routine servicing, which may be anticipated for reusable electrical devices. FDA’s MDR analyses were conducted multiple times during the reclassification process and showed trends of increased reporting, but with an associated sharp decline in the relative number of death and injury reports over the last several years (i.e., the increased reporting was largely for device malfunctions).”

The National Center for Health Research said in its comment from 2014, in which it "strongly opposed" the down-classification of both types of devices: "We don’t consider 25 deaths, 264 injuries, and more than 3,500 malfunctions a 'low frequency' and point out that other devices have been restricted or recalled for much lower rates of reported serious adverse reactions.  The FDA’s Total Product Life Cycle (TPLC) database is consistent with the high MAUDE numbers we found. TPLC data shows 3,235 problems reported for EPPG devices in the last five years."

But FDA said the trend in the statistics is “indicative of tighter adherence to MDR requirements and a related change in reporting practices rather than a change in device performance. FDA’s detailed review of MDRs for EPPG devices also did not suggest design or functional issues that would be decreased by requiring premarket approval for EPPG devices.”

“FDA also reviewed device recalls for EPPGs over the past 15 years and did not find evidence indicating the need for class III premarket approval regulation of these devices,” the order says.

One comment suggested that EPPG devices remain in class III and require PMAs because FDA failed to identify new information on which to base the reclassification recommendation, specifically noting: (1) Performance standards developed in support of PMAs are not publicly available, and (2) FDA used information submitted in response to the 515(i) Order that was not publicly available in the agency’s analysis of risks to health for EPPG devices.

“While the 2013 Panel agreed with the identified risks to health presented at the September 11, 2013, meeting, it recommended that FDA consider rewording some of the language for clarity and also to ensure that certain hazards, such as asynchronous pacing and arrhythmia induction, are included in the risks to health,” the final order says. “FDA agreed with the 2013 Panel’s recommendations and modified the risks to health accordingly as outlined in section V of the 2014 proposed order. The Agency identified in the proposed order special controls, including non-clinical performance testing data and labeling that, together with general controls (including prescription use), would provide reasonable assurance of the safety and effectiveness of EPPG devices.”

What Manufacturers Need to Do

Following the effective date of this final order, FDA says that firms marketing an EPPG or PSA device “must comply with the applicable mitigation measures set forth in the codified special controls.”

“Manufacturers of EPPG or PSA devices that have not been legally marketed prior to the effective date of this final order, or models (if any) that have been marketed but are required to submit a new 510(k) under 21 CFR 807.81(a)(3) because the device is about to be significantly changed or modified, must obtain 510(k) clearance and demonstrate compliance with the special controls included in this final order, before marketing the new or changed device,” FDA says.

Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers

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