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Andy Farb

Andy Farb

Chief Medical Officer of the Division of Cardiovascular Devices at FDA's Center for Devices and Radiological Health; cardiologist and cardiovascular pathologist with expertise in structural heart disease and early feasibility clinical studies.

Jul 1, 2026

Michael MackMODERATOR
21:12
Andy, let's step back a minute here.
21:15
Yeah, let's pause for a moment.
21:17
Yes, exactly.
21:18
So we've all been there.
21:22
TAVR was a transformative technology that entered the landscape and with it, it transformed the way we think about post-approval studies and the NCD and our working with CMS colleagues was a great way that our typical standalone post-approval studies used to be done were evolved into a joined effort under the NCD with the requirement for registry and then the execution of the TVT registry to fully align the FDA post-approval study requirements, which is hopefully showing continued assurance of safety and effectiveness with the CMS and NCD requirements to support reasonable and necessary coverage determination.
22:20
And so as we go forward, is it surprising that after many years that we rethink about the process and then evolve that and change that based on new data? No, I think that's fully expected.
22:33
But again, when we do that, we want to maintain what has been working so well, which is a process that's been inclusive of all the stakeholders, where their alignment of the clinical needs for the providers and the patients, as well as, and I would argue, fully consistent with the regulatory needs of safe and effective devices being available to the patients, and that we continue this collaborative process of shared sense of purpose as we make these changes going forward.

48 MINS LATER

Roxana MehranMODERATOR
71:44
What do you think about this with this current CED?

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