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...
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.
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...
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.
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.
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.