Thanks to the new user fee legislation known as the FDA Reauthorization Act (FDARA), the Food, Drugs and Cosmetics Act (FDCA) has been amended to allow for third-party reviews of Class II devices intended to be permanently implantable, life-sustaining or life-supporting.
But which devices will be allowed such third-party reviews and what will be the implications? That decision will come from FDA, which has to issue guidance on the topic sometime in the next two years, and at least one lawyer thinks FDA will take a cautious approach.
"The statute previously stated that the third-party review program does
not apply to a class II device that is intended to be permanently implantable
or life sustaining or life supporting. FDARA amends this limitation to allow
third-party review if FDA so determines in accordance with the guidance," a new white paper from Covington said. "The statute also previously stated that the third-party review
program does not apply to a class II device that requires clinical data
(subject to a limitation on the ratio of such devices to the total number of
510(k)s). FDARA eliminates this limitation but adds that third-party review may
not be used for: (1) a device classified pursuant to a de novo classification
request or designated as a breakthrough device; or (2) a device of a type
listed as not eligible for review in the guidance."
Background on FDARA and Third-Party Reviews
President Donald Trump in late August signed a bill that reauthorizes the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, biosimilars and medical devices through 2022.
Taking effect 1 October, the 86-page law (text here) passed the House via voice vote in July and by a vote of 94-1 in the Senate in late August. It reauthorizes FDA's ability to collect set amounts of money that the biopharmaceutical and medical device industries will pay each of the next five years for consistent reviews of medical products based on timelines agreed to by industry and FDA.
In addition to setting up the fees and timelines, the law makes what could be some key changes worth tracking as they are implemented, particularly to this third-party review program, which was created by the FDA Modernization Act of 1997 (FDAMA), based on an FDA pilot.
According to FDA, “The purpose of the program is to improve the efficiency and timeliness of FDA's 510(k) process,” which is how most medical devices receive marketing clearance in the US.
Under the program, FDA accredits third parties (Accredited Persons) authorized to conduct the primary review of 510(k)s for eligible devices. By law, FDA must issue a final determination within 30 days after receiving the recommendation of an Accredited Person.
One of those changes from FDARA is amending this limitation on third-party reviews, but will this change actually lead to implantable, life-sustaining or life-supporting devices hitting the market without FDA review and only third-party reviews?
Scott Danzis, a partner in Covington & Burling’s food & drug and health care practice groups, told Focus: “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.
“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 added.
And, “Even after a device has gone through third party review, the sponsor must still submit a 510(k) to FDA,” Danzis added, 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 added.
As for the guidance that’s coming, the new law says that within 24 months of enactment, FDA must issue draft guidance on the factors the agency will use in determining whether a Class I or Class II device type is eligible for third-party review.
And when finalized, FDA must post on its website an updated list of Class I and Class II device types and the agency’s determination whether each device type is eligible or not eligible.
FDA previously published a list of devices eligible for third-party review in 2002 (with more information from 2014).