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You might be interested in the guidance document:
Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents (withdrawn 08/03/2018)
- - original post follows below - -
Here's a late-breaking scoop from FDA Legislative Watch, "FDA Finalizing Guidance For Devices Containing Antimicrobial Agents." Reportedly, revisions to a draft guidance on 510(k) submissions for devices or combination products that incorporate antimicrobial agents are awaiting final sign-off at the FDA. Apparently, one of the biggest issues for debate is whether a device is substantially equivalent to a marketed product with the same design, or whether it is a modification. Bottomline, modified devices require much more data.
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