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Sponsors of 510(k)s for electrosurgical devices and bipolar electrosurgical vessel sealers intended for general surgery should test the biocompatibility of all materials that will come into contact with the patient, a pair of FDA guidances recommend. Read More
A new UK proposal would allow the country’s healthcare administration to consider “burden of illness” as a measurable component when assessing new medical products for government reimbursement. Read More
The FDA is proposing to establish five categories of Class III devices, delineated by risks, benefits and available controls — a move that could help to streamline classification of high-risk devices and promote consistent expectations about the process. Read More
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