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  1. FDA Standards Program

Standards at FDA

What are Standards?

The term “standard” or “technical standard” means: The common and repeated use of rules, conditions, guidelines or characteristics for products or related processes and production methods, and related management systems practices.

What do Standards Do?

Standards define terms; classify components; delineate procedures; specify dimensions, materials, performance, designs, or operations; measure quality and quantity in describing materials, processes, products, systems, services, or practices; test methods and sampling procedures; or describe fit and measure size or strength.

Why are Standards Important?

Standards are an essential resource for industry and FDA staff because they:

  1. Facilitate product evaluation through science-based methodologies
  2. Streamline the premarket evaluation and help in postmarket surveillance
  3. Open participation by all stakeholders for standards development
  4. Often represent best practices and leading-edge thinking
  5. Can lead to international harmonization, which is vital in a globalized economy

How do Standards Help FDA?

FDA has supported and benefitted from participating in developing and using standards for decades to support its mission. To give one example, standards help address aspects of evaluation of medical products safety and effectiveness like material specifications, testing methods, pass/fail performance criteria, and processes to address risk management and usability.

What is FDA’s Role in Developing Standards?

The Agency’s effective and meaningful participation in standards development organizations (SDOs) for the products we regulate is crucial. Every FDA center participates in developing and using consensus standards created by outside organizations. By engaging in standards development, FDA can advance Agency and industry interests. Information exchange to encourage coordination of technical discussions and information dissemination enables more effective engagement with our stakeholders and develops efficiencies in the standards-setting processes. The use of standards also promotes international harmonization.

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