The FDA is asking stakeholders for help identifying federal requirements that can be repealed or replaced under the Trump administration’s deregulatory push.
The agency opened several comment dockets — including one for CDRH — as it seeks to implement Trump’s executive order that the federal government identify two regulations for elimination for each new one proposed. The dockets will be open for the next 90 days.
In its request, the FDA said it is looking to achieve “meaningful burden reduction” while fulfilling its public health objectives.
In reviewing the comments, the agency plans to consider whether there have been advancements in science, technology or industry practices that supersede previous regulations in some way. The FDA will also consider regulatory requirements mirrored by consensus standards or third-party organizations, such as the ICH.
Trump’s executive order, issued shortly after taking office in January, directs agencies to identify regulations considered to be outdated, unnecessary or ineffective; inhibit job creation; or impose costs exceeding benefits.
The White House later narrowed the scope of the order, clarifying that it only applied to regulations with significant economic impacts of more than $100 million per year (IDDM, Feb. 3).
The CDRH docket is available here: www.regulations.gov/document?D=FDA-2017-N-5105.