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Content tagged with medical device

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House votes (again) to repeal medical device tax

The U.S. House of Representatives voted 283-132 this week to repeal the 2.3% tax levied upon medical devices as part of the Affordable Care Act.


FDA lays out plans to improve post-market medical device oversight

The FDA today laid out plans for improving post-market medical device oversight, including a significant investment in its new National Evaluation System for health Technology.


UK to recognize CE Marks for limited time in case of ‘no deal’ Brexit

The UK’s Medicines & Healthcare products Regulatory Agency will continue to recognize CE Marked products for use in the country for a limited time following a ‘no deal’ Brexit scenario, according to new guidance from the agency.


Report: FDA hiding millions of adverse event reports from docs, public

The FDA is hiding millions of medical device adverse event and malfunction reports from the public, according to a new report from Kaiser Health News.


FDA finalizes streamlined bundled, quarterly MDR reporting system

The FDA today announced it finalized its new Voluntary Malfunction Summary Reporting Program intended to streamline medical device manufacturer malfunction reporting.


FDA: Updated predicate devices will improve safety, efficacy in 510(k) clearances

The FDA yesterday released a notice explaining why it believes a push for modernizing predicate devices used in equivalence testing within the 510(k) clearance pathway will improve overall safety and effectiveness.


Surgical staplers and staples linked to 41K+ injury or malfunction reports

FDA said today that it has received more than 41,000 adverse event reports — including 366 deaths — associated with surgical staplers and staples for internal use, and that it may require stricter product review of the devices.


Fighting Misinformation Targeted at Patients in Clinical Trials

If sponsors want to enroll and retain patients, they must take steps to mediate the information overload & falsehoods that their patients are exposed to and continue to establish trusting relationships with them. Using the correct guidance as a road map, sponsors can work to drive recruitment, enrollment and completion of their trials with more robust data at a lower cost and reach their goals of regulatory approval at a faster rate.


FDA previews safety-focused STeP pathway, finalizes breakthrough device guidance

The FDA today outlined its plans for finalizing guidance on its Breakthrough Device Program as well as plans for a new Safer Technologies Program (STeP) intended to encourage device tech that significantly improves safety as compared to current devices on the market.


First guidance on new rules for certain medical devices

EMA has published the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices .