Does FDARA Open the Door to Third-Party Reviews of Implantable Devices? Lawyer Discusses

Scott Danzis is quoted in a Regulatory Focus article regarding the allowance of third-party reviews under the FDA Reauthorization Act. “While the revised statute does allow for implantable, life sustaining, or life supporting devices to be eligible for third party review, we expect that FDA will be cautious in adding such devices to that program," Danzis says. “Accordingly, while it is possible that FDA will designate some implantable or life sustaining/supporting devices to be subject to third party review, that will happen only if FDA is able to set forth a public health justification for doing so,” he adds. 

“Even after a device has gone through third-party review, the sponsor must still submit a 510(k) to FDA,” Danzis says, noting FDA conducts thorough reviews of 510(k)s, as described in this guidance. “So it is not the case that implantable/life supporting devices will enter the market with no FDA review, even if they are added to the third party program. If FDA identifies deficiencies in a third party 510(k), it will request additional information and conduct a review that is similar to a traditional 510(k),” he says.