FDA Standards Program
Participation in the development and use of standards is are integral to the execution of FDA's mission to protect and promote the public health.
Standards are an invaluable resource for industry and FDA. For decades, FDA has supported and benefited from the participation in the development and use of standards to support the Agency’s mission in protecting and promoting the public health as per the National Technology Transfer Advancement Act (NTTAA) of 1996. Effective and meaningful participation in standards development organizations (SDOs) for the products FDA regulates are critically important. The use of standards can increase predictability, streamline premarket review, and facilitate market entry and use for safe and effective regulated products.
The Office of Regulatory and Emerging Science (ORES) tracks the participation of FDA’s Standards Activities and chairs the FDA’s Standards Committee to discuss policy issues and coordinate cross-cutting standards that affect multiple centers. Examples include activities related to nanotechnology, materials, and combination products. By engaging in standards development, FDA can advance Agency and industry interests. The use of standards also promotes international harmonization.
Standard-setting activities include:
- material specifications
- testing methods
- manufacturing practices
- product standards
- scientific protocols
- the development of performance characteristics
- compliance criteria
- labeling
- other technical or policy criteria.
Resources For You
Contact us: FDAStandards@fda.hhs.gov