http://www.medicaldevicenow.com Tue, 21 May 2013 05:39:33 -0500 FeedCreator 1.7.2 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-07-12/massachusetts-passes-ammednments-to-gift-ban-law/ The third attempt to eliminate the bill altogether succeeded in the passage of changes instead. Thu, 12 Jul 2012 00:00:00 -0500 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-07-12/massachusetts-passes-ammednments-to-gift-ban-law/ http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-07-12/president-obama-signs-fda-bill-into-law/ The bill’s approval has been praised for its demonstration of bipartisanship. Thu, 12 Jul 2012 00:00:00 -0500 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-07-12/president-obama-signs-fda-bill-into-law/ http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-07-12/fda-to-release-plan-for-device-identification-system/ Device identification is mandated by the recently passed user fee legislation. Thu, 12 Jul 2012 00:00:00 -0500 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-07-12/fda-to-release-plan-for-device-identification-system/ http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-06-28/congress-passes-fda-user-fee-act-bill-awaits-presidents-approval/ The passage of the legislation praised as a rare example of bipartisan American politics. Thu, 28 Jun 2012 00:00:00 -0500 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-06-28/congress-passes-fda-user-fee-act-bill-awaits-presidents-approval/ http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-06-28/us-supreme-court-votes-to-uphold-universal-healthcare/ The most controversial aspect of the bill, the individual mandate, was also upheld. Thu, 28 Jun 2012 00:00:00 -0500 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-06-28/us-supreme-court-votes-to-uphold-universal-healthcare/ http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-06-20/fda-user-fee-reauthorization-bill-passes-house-with-voice-vote/ The next step is for the Senate to vote on the final version of the bill. Wed, 20 Jun 2012 00:00:00 -0500 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-06-20/fda-user-fee-reauthorization-bill-passes-house-with-voice-vote/ http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-06-01/house-passes-user-fee-reauthorization/ House and Senate must now reconcile their versions of the legislation. Fri, 01 Jun 2012 00:00:00 -0500 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-06-01/house-passes-user-fee-reauthorization/ http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-06-01/mdma-election-panel-discusses-medical-device-industry-strategy/ Meeting participants upbeat about user fee passage, applaud House action on device tax repeal. Fri, 01 Jun 2012 00:00:00 -0500 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-06-01/mdma-election-panel-discusses-medical-device-industry-strategy/ http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-05-25/user-fee-re-authorization-clears-the-senate/ Machinations to repeal device tax continue. Fri, 25 May 2012 00:00:00 -0500 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-05-25/user-fee-re-authorization-clears-the-senate/ http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-05-17/mdma-letter-to-irs-restates-position-on-device-tax/ Association says there should be a delay in final rules until industry's concerns are adequately addressed. Thu, 17 May 2012 00:00:00 -0500 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-05-17/mdma-letter-to-irs-restates-position-on-device-tax/ http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-04-26/new-advamed-chairman-presents-associations-goals/ Looking ahead, Dvorak has plans extending till after his contract ends. Thu, 26 Apr 2012 00:00:00 -0500 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-04-26/new-advamed-chairman-presents-associations-goals/ http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-04-11/fda-accepts-three-companies-for-innovation-pathway-approval-process/ The fast-track approval program is a desirable prize for company applicants. Wed, 11 Apr 2012 00:00:00 -0500 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-04-11/fda-accepts-three-companies-for-innovation-pathway-approval-process/ http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-03-29/fda-issues-guidance-on-considerations-used-in-device-approval-de-novo-decisions/ Agency says guidance outlines process for clinical data, risks, benefits and patient risk tolerance. Thu, 29 Mar 2012 00:00:00 -0500 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-03-29/fda-issues-guidance-on-considerations-used-in-device-approval-de-novo-decisions/ http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-03-21/user-fee-agreement-a-step-closer/ Public meeting to be held soon. Wed, 21 Mar 2012 00:00:00 -0500 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-03-21/user-fee-agreement-a-step-closer/ http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-03-21/lawmakers-propose-udi-law/ Legislation would require FDA final rule by the end of the year. Wed, 21 Mar 2012 00:00:00 -0500 http://www.medicaldevicenow.com/contents/view_regulatory-news/2012-03-21/lawmakers-propose-udi-law/