Legislation
In an effort to streamline AI rules for high-risk systems and improve competitiveness, two European Parliament committees agreed amendments to the EU AI Act that will allow medtech companies to avoid double certification with notified bodies. A plenary vote takes place in late March.
Small Biz Bill A Big Win For Medtech Innovation: Bipartisan Legislation Awaits President’s Signature
The US Congress overwhelmingly passed legislation reauthorizing federal programs essential to smaller medtech firms in need of funding. AdvaMed says the bill is critical for medtech innovation.
A recent FDA report to Congress reflects ongoing safety issues with orthopedic and cardiac implants, as well as commodities such as syringes and PPE.
The Trump EPA wants to loosen restrictions the Biden administration placed on facilities that sterilize medical devices with ethylene oxide, arguing the rollbacks are necessary to ensure device accessibility and supply chain security. Opponents to the rollbacks say EtO is a danger to public health.
During the latest round of MDUFA negotiations, the FDA and medtech industry agreed to include language in the next commitment letter that would provide direction for the use of carryover funds from user fees. The parties also found agreement on several other topics.
During MDUFA negotiations held Feb. 11, the medtech industry agreed to a proposal from the FDA to base its hiring commitments on MDUFA IV.
CMS is asking stakeholders to help the agency craft potential regulatory changes aimed at bolstering its efforts to combat Medicare and Medicaid fraud. The agency has provided several topics to help guide stakeholder engagement.
The latest round of MDUFA VI negotiations discussed different perspectives between the FDA and industry on TAP 2.0 and the agency’s proposals for enhancing the program.
A federal district court in Oregon denied the state’s motion to dismiss certain constitutional claims brought forward by a trade association in a suit filed last year over the state's Extended Producer Responsibility law. The case likely has implications for EPR laws across the country.
AdvaMed welcomed the Supreme Court’s recent decision to strike down the Trump administration’s policy on imposing tariffs on US trade partners, though the trade group doesn’t see the tariff issue going away.
The US Supreme Court struck a blow to the Trump administration’s efforts to impose sweeping tariffs, ruling the president exceeded his authority. Limiting tariffs has been a priority for the medtech industry.
A new report from the Senate HELP Committee offers regulatory and legislative reforms aimed at offering patients faster access to medical innovations, including changes to AI and digital health regulation.
AdvaMed president Scott Whitaker said the group is focused on the need for tariff stability in conversations with the Trump administration. The organization remains optimistic about other policy areas. New chairman and ResMed CEO Mick Farrell laid out his five priorities.
As medtech moves toward 2026, experts highlight increased regulatory complexities, particularly around AI, cybersecurity, and device user fees. Urgent regulatory updates are needed to keep pace with rapid technology changes while ensuring patient safety and operational efficiency.
The FDA and medtech industry held multiple meetings last month to continue talks for the next round of medical device user fee amendments. Stakeholder priorities included resource planning, fee structure reforms, IT enhancements, international harmonization, and real-world evidence.
In this second of a three-part series, Medtech Insight spoke with three neuroethicists who raised concerns about privacy, patient safeguards and the need for comprehensive guidelines. These issues are becoming more pressing as BCI companies get ready to commercialize their products.
As requested by a pair of US senators, the GAO has published a report on how the FDA handles medical device recalls. The review found that the agency lacks the necessary staff and regulatory authority to process recalls safely and effectively.
Rapid advancements in neurotechnology intensify the need for clear regulations concerning neural data privacy. As these technologies evolve at unprecedented speeds, lawmakers, legal experts, and neuroethicists are increasingly focused on their societal impact.
A recent study demonstrates that certain types of blood-based tests that screen for multiple cancers at once have the potential to flip the script on cancer diagnoses, including some of the deadliest types.
But the Senate’s reduction would not be as much as the House of Representatives and President Trump proposed earlier this year, which is likely a win for the agency.