Medtech's Unfinished Business For Congress In 2018: What's Ahead
• By Sue Darcey
US Congress successfully pushed through a user-fee bill in 2017 to help smooth the regulatory path at FDA for medical devices and other products, but other efforts, including several industry priorities, remain undone. On top on the list, of course, is the effort to repeal the device excise tax. But legislation is also on the table to address diagnostics regulation, telehealth reimbursement, and medtech cybersecurity vulnerability, among other issues. Here is a look at the medtech landscape in Congress in 2018.
US Capitol Building
[Editor's note: Follow progress with legislation impacting the device and diagnostics industry with Medtech Insight's US Congress Tracker.]
In 2017, the Republican-led US House and Senate managed to push through a slate of FDA reform provisions, under the banner of the user-fee FDA Reauthorization Act that was championed...
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During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
A battle may be forming over the 2027 FDA user fee reauthorizations. At a conference Friday, Democratic Rep. Jake Auchincloss supports them for their effectiveness, while Deputy FDA Commissioner Grace Graham echoed criticisms from HHS Sec. Kennedy, among others, in calling for reform to ensure public trust.
Health and Human Services Secretary Robert F. Kennedy Jr. emphasized administrative cost reductions and defended budget decisions during a Senate hearing on HHS funding. Some senators, however, expressed concerns over the impacts spending cuts had on essential health programs.
During his testimony before US senators on the impact of tariffs on critical supply chains, AdvaMed’s Scott Whitaker said the Trump tariffs could jeopardize America’s preeminence in medtech. Other industry experts echoed similar concerns.
Predictability, proportionality, stability, harmonization and simplification offer the right way forward to address the challenging unintended effects of the EU medical device regulations, the European Commission’s head of devices tells the EU’s largest annual medtech conference.
Now that the landmark Pandemic Agreement has finally been adopted, work will start on drafting a pathogen access and benefit sharing system that will be voluntary for use by drug companies.
The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.
