On The Virtual Horizon? FDA Revising Software Guidance, Part 11 Policy
This article was originally published in The Gray Sheet
Executive Summary
Stakeholders will have an opportunity to comment on FDA's evolving policy on Part 11 electronic records regulation during a June meeting
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Modular PMA goals: FDA should complete review of 70% of PMA modules within 90 days, starting in fiscal 2006, AdvaMed proposes in Jan. 7 comments to FDA. Under the plan, 80% of modules would be completed in 90 days in 2007. AdvaMed's review performance targets differ from two proposals FDA offered at a November MDUFMA stakeholder meeting (1"The Gray Sheet" Nov. 29, 2004, p. 4). Under one agency option, 70% of modules would be completed within 120 days in 2006, rising to 80% in 2007. The alternative pledged 50% in 90 days in 2006, increasing to 60% in 2007. FDA's proposals "simply codify current performance levels, which have declined since the passage of MDUFMA," AdvaMed protests in its comments to FDA. Maintaining that user fees provide for additional review resources and that Congress has fully funded FDA for FY 2005 as required by MDUFMA, AdvaMed contends that its proposed targets for the agency are "reasonable and represent appropriate incremental improvement over current review performance"...
Regulatory News In Brief
Modular PMA goals: FDA should complete review of 70% of PMA modules within 90 days, starting in fiscal 2006, AdvaMed proposes in Jan. 7 comments to FDA. Under the plan, 80% of modules would be completed in 90 days in 2007. AdvaMed's review performance targets differ from two proposals FDA offered at a November MDUFMA stakeholder meeting (1"The Gray Sheet" Nov. 29, 2004, p. 4). Under one agency option, 70% of modules would be completed within 120 days in 2006, rising to 80% in 2007. The alternative pledged 50% in 90 days in 2006, increasing to 60% in 2007. FDA's proposals "simply codify current performance levels, which have declined since the passage of MDUFMA," AdvaMed protests in its comments to FDA. Maintaining that user fees provide for additional review resources and that Congress has fully funded FDA for FY 2005 as required by MDUFMA, AdvaMed contends that its proposed targets for the agency are "reasonable and represent appropriate incremental improvement over current review performance"...
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