The lifespan of medical devices is growing longer as more and more hospitals are turning to device reprocessing to cut costs, reduce waste and maximize potential use of these items. Millions of single ...
The US Food and Drug Administration (FDA) on Wednesday finalized guidance on its 510(k) third party review program (3P510k) detailing how it will determine whether different types of devices are ...
Every healthcare facility faces the same challenge: to reduce costs without sacrificing the delivery of quality care. As a result of dwindling healthcare reimbursements, and increased awareness of ...
The US Food and Drug Administration (FDA) has published a draft guidance that updates a 2020 final guidance on its third party 510(k) review program (3P510K). Besides pointing out new updates to the ...
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