Burgess Takes Issue With Sunstein Defense Of Device Reg Review Process

Rep. Michael Burgess (R-TX) says White House regulations chief Cass Sunstein did not adequately provide a response to an inquiry on how FDA can better incorporate device industry input in the development of guidance documents. Sunstein defended FDA, arguing that both the administration’s Office of Information and Regulatory Affairs and the agency have processes in place to ensure that the public can provide input in policy development. His defense came in a response to questions for the record from a recent Capitol Hill hearing.

The White House earlier this year issued an executive order calling for federal agencies to list regulations that are overly burdensome on industry or ineffective, with the administration finalizing those plans this week. In response to the regulatory review, the House Energy and Commerce’s oversight subpanel convened hearings on the plans, with some Republicans contending that reforms to many of the listed regulations would not lift a burden on industry.

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