Wednesday, September 3, 2008

Medical Devices Containing Antimicrobial Agents - FDA Guidance Pending

Updated January 16, 2017

The link in the original post is no longer valid.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Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents

- -  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 Reportedly, revisions to a draft guidance on 510(k) submissions for devices or combination products that incorporate antimicrobial agents are awaiting final sign-off at the FDA.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
Who Offers Live Onsite GMP Training?
SkillsPlus Intl Info Blog

The Designated Rep and Exemptee Professionals Blog
The Health, Drug, Prescription, and GMP Supersite Gift Store 

TrackBack URL for the article cited above:

No comments:

From SkillsPlus International Inc.

Custom Search

Even More Resources, Books, & Things (many from

    GMP Training Gifts & Giveaways