Agencies Launch White House-Mandated Review Of Regulations

Article preview from "The Gray Sheet"- May 30, 2011

FDA and CMS announced preliminary plans May 26 for updating, streamlining or eliminating certain regulations in response to a White House request.The targeted rules include a collection of device-specific initiatives, although many of the efforts pre-date the Obama administration initiative.

Agencies Launch White House-Mandated Review Of Regulations

Article preview from "The Gray Sheet"- May 30, 2011

FDA and CMS announced preliminary plans May 26 for updating, streamlining or eliminating certain regulations in response to a White House request.

The targeted rules include a collection of device-specific initiatives, although many of the efforts pre-date the Obama administration initiative.

Among the priorities: converting adverse event reporting to an electronic system, downclassifying more devices to lower risk categories, and allowing manufacturers to use validated symbols in device labeling in place of English text.

At the request of the Obama administration, 30 departments and agencies, including the Department of Health and Human Services, are scrutinizing existing regs.

The goal is "to remove what the president has called unjustified rules and absurd and unnecessary paperwork requirements that waste time and money," Cass Sunstein, administrator of the White House Office of Information and Regulatory Affairs, said on a May 26 call hosted by the American Enterprise Institute.

Continued...

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