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The Medical Device Manufacturers Association is urging members of Congress and other stakeholders to address provisions in anti-patent troll legislation that the group says could harm small medtech innovators. Read More
The FDA may withdraw a humanitarian device exemption if it subsequently approves a PMA or clears a 510(k) for the humanitarian-use device or a comparable device with the same indication, a draft Q&A guidance on HDEs explains. Read More
The European Commission’s Scientific Committee on Emerging Newly Identified Health Risks is recommending a step-by-step approach to the introduction of new or technically modified metal-on-metal joint implants, citing continued concerns about the higher risks and poorer durability vis-à-vis alternative materials such as polyethylene. Read More
New FDA draft guidance on blood glucose test systems, released in January, shouldn’t lengthen approval times, a CDRH official assured devicemakers Wednesday during a webinar hosted by the American Association for Clinical Chemistry. Read More
The HHS Office of Inspector General plans to step up efforts to prevent fraud and overspending for diabetes test strips, releasing a host of findings about false claims, questionable billing and pricing. Read More