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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.


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.


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.


Trump tariffs place nearly $1 billion in duties on the medtech industry

The U.S. medical device industry is facing nearly $1 billion in tariffs from the Trump administration, about $4 billion less than what was originally expected. Customs and Border Protection began collecting the additional duties on July 6.


FDA sets March dates for microbiology, neurology device panel meetings

The FDA this week set two new March dates for public medical device advisory committee meetings, the first to discuss microbiology devices and the second to discuss a specific neurological device, according to official FDA releases.


Untangling the Complexities of Clinical Trials

genae was interviewed by Pharma Tech Outlook on the complexities of clinical trials. Discover this must-read article and how genae identified an unmet need for excellence in medical device clinical trials.