Medical device makers will have to start paying a fee on sales of their goods, after the Senate wouldn’t delay or repeal the tax before the 115th Congress ended.
The FDA set a new record for generic drug approvals in fiscal 2018, and now it aims to speed its nods to new devices like upgraded hearing aids in the new year.
The FDA will continue to review potentially risky medical products imported into the U.S. during the partial government shutdown, according to agency Commissioner Scott Gottlieb.
Device-specific records may become available to the public sooner, thanks to the FDA.
The FDA offered medical device makers another option to get products on the market faster, promoting a “least-burdensome approach” to review innovative devices.
A joint House panel will examine the use of fetal tissue for research Dec. 13, just a few days after the NIH announced it would foot a $20 million bill for research substitutes.
The medical device industry plans to keep up its battle for repeal of a tax on sales of its goods, not just an extended deadline.