Hi Folks,
I wanted to bring up something that's been on my mind. You might have seen the recent FDA final guidance on Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J. I am a bit puzzled about whether this notification implies the cancellation of marketing clearance, including listing, 510(k), and PMA.
Our company has a few 510(k) exempt devices (which happen to be included in the 506J proposed device list) listed for applying the CFG only. These devices are not for sale in the USA but still being supplied to other overseas countries. In this situation, do we need to inactive such a listing and notify the FDA?
I'd really appreciate your thoughts on this. Feel free to leave any comments below. Thanks a bunch!
Best Regards,
Emma
I wanted to bring up something that's been on my mind. You might have seen the recent FDA final guidance on Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J. I am a bit puzzled about whether this notification implies the cancellation of marketing clearance, including listing, 510(k), and PMA.
Our company has a few 510(k) exempt devices (which happen to be included in the 506J proposed device list) listed for applying the CFG only. These devices are not for sale in the USA but still being supplied to other overseas countries. In this situation, do we need to inactive such a listing and notify the FDA?
I'd really appreciate your thoughts on this. Feel free to leave any comments below. Thanks a bunch!
Best Regards,
Emma
