510(k) form update
This article was originally published in The Gray Sheet
Device center modifies 510(k) "indications for use" 1form to facilitate bundling of Rx/OTC premarket notifications. The old form asked sponsors to choose prescription use or over-the-counter use, while the updated form gives the option of OTC and/or Rx. With some devices, the main difference between prescription and OTC versions are different instructions for professional and lay audiences, CDRH explains, adding that sponsors may wish to bundle the premarket notifications. The device center also has modified its database to accommodate Rx/OTC 510(k)s. CDRH's in vitro diagnostics office in particular is "encouraging the immediate use" of the new form for "all 510(k) submissions"...
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