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The FDA could sign off on STAAR Surgical’s Visian Toric Implantable Collamer Lens within the next several months, following an advisory panel’s conclusion that the lens is approvable. 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
New FDA draft guidance on blood glucose test systems, released in January, shouldn’t lengthen approval times, a CDRH official assured devicemakers Wednesday during a webinar hosted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
When applying CLIA categorization of diagnostics, CDRH plans to alert sponsors to the categorization within two weeks of a positive marketing decision, the agency says. Read More