Key result
The FDA clarified that it has not made an absolute decision to forgo new clinical data requirements for all implantable leads with IS-4 connectors.
Clarifies the FDA's position on the requirement for clinical data for implantable leads with IS-4 connectors.
To the Editor: In their Perspective article in this issue of the Journal, Hauser and Almquist1 discuss issues involved in the testing of implantable cardioverter–defibrillators (ICDs). The authors contend that “the decision by the FDA [Food and Drug Administration] and industry to forgo premarketing clinical testing of the [new quadripolar,2 or IS-4] connector is not in the best interest of patients.” This is an incorrect description of the position of the FDA. The FDA has made no absolute decision that all implantable leads with IS-4 connectors will not require new clinical data. When we are evaluating an application for a . . .
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Shein et al. (2008) conducted a letter in Implantable cardioverter-defibrillator (ICD) testing. The FDA clarified that it has not made an absolute decision to forgo new clinical data requirements for all implantable leads with IS-4 connectors.
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