Wednesday, September 3, 2008

Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending

Updated October 22, 2020

The link in the original post is no longer valid.

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Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents (withdrawn 08/03/2018)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 Reportedly, revisions to a draft guidance on 510(k) submissions for devices or combination products that incorporate antimicrobial agents are awaiting final sign-off at the FDA.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.

Return Home: The Health, Drug, Prescription, and GMP Supersite Blog

If you are looking for live, onsite, in-person delivered courses or classes, then consider the following popular courses:
Root Cause Analysis & Deviation Investigation Report Writing - cGMP Training
Our most popular course
Qualstar - Pharmaceutical Simulation - Advanced cGMP Training
Put fun back into GMP training!














SkillsPlus Intl Inc. - The best GMP training, best QSR training, best instructors
SkillsPlus Intl Info Blog

No comments:

From SkillsPlus International Inc.