Introduction to Building 66 at the FDA

Building 66, located at the FDA White Oak Campus in Silver Spring, Maryland, is a pivotal facility for the U.S. Food and Drug Administration (FDA). It houses the Center for Devices and Radiological Health (CDRH). This building is part of a larger campus that embodies the FDA's commitment to operational excellence and scientific advancement in public health.

Development of the White Oak Campus

The FDA White Oak Campus was established following the FDA Revitalization Act of 1990, aimed at consolidating various FDA operations into a single location to enhance efficiency and collaboration. The campus encompasses ten office buildings and four laboratory buildings, totaling approximately 3.1 million rentable square feet. Building 66 was officially dedicated on May 11, 2009, marking a significant milestone in the FDA's efforts to modernize its facilities and improve its regulatory capabilities.

Legislative Framework

Various legislative acts have supported the construction and expansion of the White Oak Campus, including the Family Smoking Prevention and Tobacco Control Act of 2009, FDA Food Safety Modernization Act of 2011, FDA Safety and Innovation Act of 2012, Drug Quality and Security Act of 2013, 21st Century Cures Act of 2016, and FDA Reauthorization Act of 2017.

Design and Structure

Building 66 is designed to facilitate the work of CDRH, which ensures that medical devices and radiological health products are safe and effective. The building has been recognized for its sustainable design practices, earning LEED certification from the U.S. Green Building Council, indicating it meets high standards for energy efficiency and environmental sustainability.

The interior layout is optimized for administrative functions and scientific research, featuring state-of-the-art laboratories for testing and evaluating medical devices, office spaces designed to foster communication and collaboration, and meeting rooms for discussions, presentations, and training sessions. Recent renovations included an accessible walkway connecting Building 10 to Building 66 with a climate-controlled vestibule.

Mission and Responsibilities

The CDRH protects public health by regulating medical devices and ensuring their safety and effectiveness. Key responsibilities include pre-market review of new medical devices before they can be marketed, post-market surveillance to monitor devices after they reach the market, and guidance development to help manufacturers comply with regulatory standards.

Research Initiatives

The CDRH engages in various research initiatives aimed at improving device safety, including clinical studies collaborating with manufacturers to assess device performance, public health research investigating trends in device-related injuries or complications, and innovation support providing resources for emerging technologies in medical devices.

Visitor Access and Outreach

Building 66 is accessible to visitors who wish to learn more about the FDA's work. The campus offers guided tours highlighting its facilities and educational resources, and the FDA conducts outreach programs to educate healthcare professionals about regulatory processes related to medical devices.

Expansion Plans

As part of ongoing efforts to meet increasing demands for regulatory oversight, there are plans for further expansion of the White Oak Campus. The National Capital Planning Commission approved a Master Plan in December 2018 that outlines these future developments.

References

• https://www.fda.gov/about-fda/buildings-and-facilities/white-oak-campus-information

• https://www.fda.gov/about-fda/white-oak-campus-information/building-66-office-building-occupied-cdrh-0