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# Coordinate FDA Medical Product Centers Better: GAO
- URL: https://www.fdaweb.com/coordinate-fda-medical-product-centers-better-gao/
- Published: 2016-06-15T12:00:00.000Z
- Updated: 2026-09-14T21:09:45.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135952

The FDA strategic integrated management plan (SIMP) for its three Centers overseeing medical products (CBER, CDER, CDRH) does not include leading practices for strategic planning or document a comprehensive strategy for the Centers, according to a new Government Accountability Office [report](http://www.gao.gov/products/GAO-16-500?utm%5Fmedium=email&utm%5Fsource=govdelivery). In 2012, Congress required the agency to develop a SIMP for the Centers that identified initiatives for improving efficiency, initiatives for workforce development, and measures for assessing the progress of the initiative. FDA issued the SIMP 7/2013.

The GAO report evaluates the extent to which the SIMP serves as a strategic planning document; describes the types of plan initiatives; and describes the mechanism FDA has to evaluate the effectiveness of its plan initiatives.

FDA officials reportedly told GAO that circumstances at the time of the SIMP’s development, including leadership gaps, limited the agency’s ability to structure the plan into an effective strategic planning document. “While officials said they use a variety of other key documents for strategic planning, such as agency-level and initiative-specific plans,” the report says, “these other plans also do not describe a long-term strategy for addressing key issues that cut across medical product Centers. For example, these other FDA documents do not describe the agency’s plans for collaboration between the Centers that could benefit certain initiatives, improve their decision-making, and improve the quality of evidence and clarity of guidance.”

According to GAO, the absence of a comprehensive long-term plan for medical product oversight may hinder FDA’s efforts to address emerging issues that require Center collaboration, such as access to quality data. “Fully documenting such a strategy, either in a separate plan or through existing documents, would help the agency identify measurable goals and objectives for the Centers that align with its mission and help communicate its priorities to key stakeholders,” it says.

The report recommends that FDA engage in a strategic planning process to identify challenges that cut across the medical product Centers and document how it will achieve measurable goals and objectives in these areas. The agency agreed with the recommendation.