Washington, D.C.-based AdvaMed President and CEO Scott Whitaker shared his thoughts on the device tax and device company inspections, as reported by Regulatory Affairs Professionals Society.
Here are five issues he discussed:
1. Mr. Whitaker believes the tax will be repealed in the second or third quarter of this year.
2. He said, "We feel pretty good that if we move to another vehicle, whether its tax reform, State Children's Health Insurance Program reauthorization, tax extenders, that the Chairman and the leadership of the House — and the Senate, frankly — will support moving it to another vehicle."
3. Mr. Whitaker and AdvaMed support two bills in Congress seeking to overhaul the way the FDA inspects device manufacturers.
4. He trusts the Office of Regulatory Affairs' upcoming realignment will improve inspection issues but wants more to be done to fully fix the situation.
5. Mr. Whitaker also hopes the Medical Device User Fee Amendment is reauthorized this year.
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