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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.

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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.

Health Canada Proposes Changes to Priority Review Requests for Medical Device

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.