Compliance
The New Civil Liberties Alliance, which represented a plaintiff in the lawsuit last summer that ended court deference to federal agencies, is asking for a stay on the consumer protection agency’s rule on infant support cushions. The law firm argues that CPSC wrongly used an expedited process to issue the rule.
Chaos continues at the FDA’s device center as reinstated staffers begin daily commutes to comply with the administration’s return to office policy. Staffers can no longer publicly share their pronouns per Trump’s “Defending Women” executive order.
Even if manufacturing challenges don’t derail the 2025 launch plans, the regulatory setback introduces new challenges for Dexcom’s continuous glucose monitors at a time when competition from Abbott and Medtronic is intensifying.
Data recently published in The BMJ found that almost 30% of device adverse event reports filed with the US FDA are late or missing accurate date information. A relatively small number of companies account for more than half of the late reports.
Medtech Insight sat down with Arcadia's chief strategy officer Aneesh Chopra to discuss interoperability, industry standards and the future of health care data and AI.
In response to the Trump administration increasing its tariffs on imports from China, Beijing announced a ban on gene sequencers from US biotech firm Illumina, signaling a full-blown trade war could be in the making. Trump also pushed the deadline for implementing tariffs on Canada and Mexico back by another month.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 30 documents have been posted on the tracker since its last update.
A recent webinar highlighted the need for manufacturers to monitor, manage, and address software vulnerabilities under FDA cybersecurity policy. Important elements include a thorough software bill of materials, coordinated vulnerability disclosure, and maintaining system security.
As the EU AI Act takes shape, critical details are emerging rapidly. However, the approaching deadlines are even more pressing. This article delves into the essential information that medtech professionals need to stay ahead.
The EU’s new Product Liability Directive will make it easier for European consumers to seek compensation relating to defective products even if manufacturers are based outside the bloc. Legal experts caution that this could have substantial implications for pharmaceutical companies.
The Irish notified body has had to suspend IVD client work since late 2024.
Industry and healthcare professionals generally welcome the European Commission's proposal to broaden the use of eIFUs. However, more official statements are still awaited.
Anita Jackson is facing 25 years for device adulteration and a host of other charges. She says the trial and appeals court failed to consider her defense.
Two US FDA device center websites have been restored under a restraining order. The pages now carry a disclaimer alleging they include "extremely inaccurate" content about gender; however, neither site includes any substantive discussion of trans issues.
Medtechs watch with interest as NICE, a long-standing component of market access for innovative technologies in the National Health Service, vows to get to grips with technology programs that often miss the target for developers of groundbreaking solutions.
For the fourth time in as many years the FDA has issued a communication concerning a key accessory from Olympus used in several types of urological procedures. This time, however, the agency has added a class I recall confirmation to its original early alert on the device issued in December 2024. A device safety specialist provided Medtech Insight with a deeper understanding of the problem as well as overall scope safety.
The US FDA says in a legal memo that its new guidance on scientific information on unapproved uses (SIUU) is “speech-enabling” and argues that challenges should be interpreted as attempts to roll back the approval process.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 80 documents have been posted on the tracker since its last update.
The FDA's recent communication freeze has blocked participation in international standards development groups. The agency's absence could impact the alignment of US and international standards, potentially affecting medical device manufacturers' ability to sell products globally.
The US FDA says diabetes patients who rely on their smartphones to receive critical disease-related alerts should ensure their phones are configured correctly. If not, the alerts might be missed.