It’s a new year – and that means the US Congress has some unfinished business to tend to.
Among the device-related issues that Congress left pending in 2019 – but which legislators are likely to revisit in the...
2020 Outlook: US Congress Will Address Surprise Billing, Ratify USMCA, Conduct More Medtech Safety Oversight
Congress was able to approve a permanent medical device tax repeal and pass a “LAB Act” bill favorable to the diagnostic industry in 2019. But what device-related legislation is ahead in 2020? Medtech Insight takes a look at some of the medtech bills and draft legislation likely to affect manufacturers pending in late 2019 that are likely to be reviewed – and perhaps approved – in 2020.
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Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
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Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
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The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.