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.
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.
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.
The FDA today announced it finalized its new Voluntary Malfunction Summary Reporting Program intended to streamline medical device manufacturer malfunction reporting.
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Health Canada intends to modify its policy for medical device manufacturers to request priority reviews by nixing its requirement on a separate submission and adding a new required criterion for eligibility.
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.
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.