FDA Final Order for Medical Device Reclassification
Reclassification of Cardiovascular Devices
External Pacemaker Pulse Generator and Pacing System Analyzers
21 CFR Part 870
FDA issues Final Order, effective as of April 18, 2016, to reclassify external pacemaker pulse generator (EPPG) as well as to create a separate classification regulation for pacing system analyzers (PSAs) devices and reclassify PSA devices into class II (special controls).
FDA’s reclassification is based on new information and subject to premarket notification.
The EPPG devices are currently class III devices (preamendments) under product code “DTE.”
According to the Final Order, it creates a separate classification regulation for PSAs places single and dual chamber PSAs, which are currently classified with EPPG devices, and triple chamber PSAs (TCPSAs), which are currently postamendments class III devices, into that new classification regulation.
In view of various information, FDA concludes that special controls, in conjunction with general controls, will provide reasonable assurance of the safety and effectiveness of EPPG and PSA devices.
Under section 513(d) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as preamendments devices), are classified after FDA has:
- Received a recommendation from a device classification panel (an FDA advisory committee);
- published the panel’s recommendation for comment, along with a proposed regulation classifying the device; and
- published a final regulation classifying the device.
FDA has classified most preamendments devices under these procedures.
Download Final Order
Preamendments Class III Devices
A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification (510(k)) procedures to such a preamendments device or to a device within that type (both the preamendments and substantially equivalent devices are referred to as preamendments class III devices) may be marketed without submission of a premarket approval application (PMA) until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval or until the device is subsequently reclassified into class I or class II.
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Last Updated: 2016-04-19
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