Comments on: FDA asks Device Makers…But, what about the kids!?! http://my510k.com/fivetenblog/pediatrics/fda-asks-device-makers-but-what-about-the-kids Social Media in the Medical Device World Fri, 23 Apr 2010 00:07:30 +0000 http://wordpress.org/?v=2.9.2 hourly 1 By: uberVU - social comments http://my510k.com/fivetenblog/pediatrics/fda-asks-device-makers-but-what-about-the-kids/comment-page-1#comment-75 uberVU - social comments Mon, 05 Apr 2010 21:26:22 +0000 http://my510k.com/fivetenblog/?p=168#comment-75 <strong>Social comments and analytics for this post...</strong> This post was mentioned on Twitter by odomlewis: RT @my510k: In case you missed it - FDA asks Device Makers...what about the kids!?! http://bit.ly/dAIGl1 #medicaldevices #pediatrics #peds... Social comments and analytics for this post…

This post was mentioned on Twitter by odomlewis: RT @my510k: In case you missed it – FDA asks Device Makers…what about the kids!?! http://bit.ly/dAIGl1 #medicaldevices #pediatrics #peds…

]]> By: Tweets that mention Five-Ten Blog - FDA asks Device Makers…But, what about the kids!?! -- Topsy.com http://my510k.com/fivetenblog/pediatrics/fda-asks-device-makers-but-what-about-the-kids/comment-page-1#comment-69 Tweets that mention Five-Ten Blog - FDA asks Device Makers…But, what about the kids!?! -- Topsy.com Fri, 02 Apr 2010 14:14:25 +0000 http://my510k.com/fivetenblog/?p=168#comment-69 [...] This post was mentioned on Twitter by Sarah Glenn and Tina Avanzato Chiodo, Brad Ryba. Brad Ryba said: In case you missed it - FDA asks Device Makers...what about the kids!?! http://bit.ly/dAIGl1 #medicaldevices #pediatrics #peds [...] [...] This post was mentioned on Twitter by Sarah Glenn and Tina Avanzato Chiodo, Brad Ryba. Brad Ryba said: In case you missed it – FDA asks Device Makers…what about the kids!?! http://bit.ly/dAIGl1 #medicaldevices #pediatrics #peds [...]

]]> By: Brad Ryba http://my510k.com/fivetenblog/pediatrics/fda-asks-device-makers-but-what-about-the-kids/comment-page-1#comment-68 Brad Ryba Fri, 02 Apr 2010 05:23:07 +0000 http://my510k.com/fivetenblog/?p=168#comment-68 Thanks for clarifying this and including the link to the proposed federal notice. Actually, the timing is listed in the final ruling (http://edocket.access.gpo.gov/2010/2010-7193.htm) which is effective August 16, 2010. Public comments can be submitted on the direct final rule by June 15, 2010. I have updated my post just a bit, based on your comments and some additional research. The section III does call out HDE, PMA and PDP submissions, and since 510(k) was not explicitly excluded, it would be wise consider that it may be included at some point. After the comment period I would not be surprised to see this apply to 510(k) as well. Good to have you as a contributor...thanks! Thanks for clarifying this and including the link to the proposed federal notice. Actually, the timing is listed in the final ruling (http://edocket.access.gpo.gov/2010/2010-7193.htm) which is effective August 16, 2010. Public comments can be submitted on the direct final rule by June 15, 2010. I have updated my post just a bit, based on your comments and some additional research. The section III does call out HDE, PMA and PDP submissions, and since 510(k) was not explicitly excluded, it would be wise consider that it may be included at some point. After the comment period I would not be surprised to see this apply to 510(k) as well. Good to have you as a contributor…thanks!

]]> By: uberVU - social comments http://my510k.com/fivetenblog/pediatrics/fda-asks-device-makers-but-what-about-the-kids/comment-page-1#comment-61 uberVU - social comments Thu, 01 Apr 2010 19:48:53 +0000 http://my510k.com/fivetenblog/?p=168#comment-61 <strong>Social comments and analytics for this post...</strong> This post was mentioned on Twitter by my510k: New Blog Post - FDA askes Device Makers...But, what about the kids!?! http://bit.ly/bDMFNs #medicaldevices #my510k #pediatrics #peds... Social comments and analytics for this post…

This post was mentioned on Twitter by my510k: New Blog Post – FDA askes Device Makers…But, what about the kids!?! http://bit.ly/bDMFNs #medicaldevices #my510k #pediatrics #peds…

]]> By: blewispunk http://my510k.com/fivetenblog/pediatrics/fda-asks-device-makers-but-what-about-the-kids/comment-page-1#comment-58 blewispunk Thu, 01 Apr 2010 18:07:22 +0000 http://my510k.com/fivetenblog/?p=168#comment-58 My understanding from the FR notice (http://edocket.access.gpo.gov/2010/2010-7192.htm) is that this does not apply to 510(k) submissions. Per section III it only applies to HDE, PMA, and PDP submissions. Also, when I looked at something on this the other day I thought the effective date was in August. Great post though, just want to make sure it is taken to apply to the right types of applications and in the appropriate timeframes. My understanding from the FR notice (http://edocket.access.gpo.gov/2010/2010-7192.htm) is that this does not apply to 510(k) submissions. Per section III it only applies to HDE, PMA, and PDP submissions.

Also, when I looked at something on this the other day I thought the effective date was in August.

Great post though, just want to make sure it is taken to apply to the right types of applications and in the appropriate timeframes.

]]> By: Tweets that mention Five-Ten Blog - FDA askes Device Makers…But, what about the kids!?! -- Topsy.com http://my510k.com/fivetenblog/pediatrics/fda-asks-device-makers-but-what-about-the-kids/comment-page-1#comment-57 Tweets that mention Five-Ten Blog - FDA askes Device Makers…But, what about the kids!?! -- Topsy.com Thu, 01 Apr 2010 17:48:32 +0000 http://my510k.com/fivetenblog/?p=168#comment-57 [...] This post was mentioned on Twitter by TrackWise and Brad Ryba, Brad Ryba. Brad Ryba said: New Blog Post - FDA askes Device Makers...But, what about the kids!?! http://bit.ly/bDMFNs #medicaldevices #my510k #pediatrics #peds [...] [...] This post was mentioned on Twitter by TrackWise and Brad Ryba, Brad Ryba. Brad Ryba said: New Blog Post – FDA askes Device Makers…But, what about the kids!?! http://bit.ly/bDMFNs #medicaldevices #my510k #pediatrics #peds [...]

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