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1. Purpose
This Policy Statement establishes Agency-wide policies and procedures and describes responsibilities for implementing the Office of Management and Budget Circular No. A-119, “Federal Participation in the Development and Use of Voluntary Standards,” within the US Food and Drug Administration (FDA).
2. General
This Policy Statement is based on and incorporates the information provided: by statute in the National Technology Transfer and Advancement Act (NTTAA; PL 104-113); by OMB directive (OMB A-119); by regulation (21 CFR 10.95, Participation in outside standard-setting activities); by the existing FDA Policy on Standards (“Policy regarding the development and use of standards with respect to international harmonization of regulatory requirements and guidelines”, 60 FR 53078 (Oct. 11, 1995)); and by FDA Staff Manual Guide 9100.1, “Development and Use of Voluntary Standards”.
3. Policies and Scope
3.1 Implementing the previously mentioned legislation, regulation and policy statement, FDA adopts, by reference, either in their entirety or in part, standards developed through non-government organizations (NGOs) and intergovernmental international standards organizations in lieu of internally developed government-unique standards and guidance, when those standards represent the most appropriate standards for a specific purpose and are not in conflict with US statute or regulation.
3.2 FDA will preferentially use internationally harmonized standards – standards developed by organizations typically involving representatives from many countries - in their processes, when those standards represent the most appropriate standards for a specific purpose and are not in conflict with US statute or regulation.
3.3 Guidance documents published by FDA will, wherever appropriate, reference the standards, including terminology, definitions, test methods, practices, guides, and material specifications developed through voluntary consensus processes with the regulated industry and other interested parties. Wherever appropriate, these standards will be adopted in lieu of methods developed solely within FDA.
3.4 Where appropriate, FDA encourages sponsors of product applications and manufacturers to cite appropriate voluntary consensus standards in support of their applications and manufacturing process documents. Where the use of voluntary consensus standards would be inconsistent with applicable law or otherwise impractical, citation of other non-government standards should be considered.
3.5 Where FDA decides to incorporate voluntary consensus or other non-government standards/guidelines into FDA regulations or guidance, it does so under FDA’s rule on promulgation of regulations (21 CFR 10.40), other procedural regulations in 21 CFR, or under its good guidance practices regulations under 21 CFR 10.115. Unless promulgated by regulation, the use of these standards is voluntary by the industry or government.
3.6 For Medical Devices, as described in statute, FDA shall, by publication in the Federal Register, recognize all or part of an appropriate standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet a premarket submission requirement or other requirement under this Act to which such standard is applicable. (Federal Food, Drug, and Cosmetic Act Section 514(c) (1) (A) (21 U.S.C. 360d))
3.7 Engagement by an FDA employee - whether civil service or Commissioned Corps - as the liaison to activities of a standards development organization does not connote FDA agreement with, or endorsement of decisions reached or standards developed. The FDA employee remains obligated to represent and support Agency policy, practices, and priorities while engaged in these activities.
3.8 When FDA employees - whether civil service or Commissioned Corps - participate in any activity as part of their assigned duties, they are doing so in their official capacity as a U.S. government representative and not in their personal capacity, even if the invitation for such participation implies or specifies that participation is in a “personal” or “expert” capacity.
4. Responsibilities
4.1 The Office of Science and Health Coordination (OHSC) will maintain a Standards Management Program (SMP) for FDA. The SMP will develop and operate a unified standards system within FDA, including:
4.2 Office of International Programs (OIP) will maintain coordination with the OSHC on international trade issues, e.g. Mutual Recognition Agreements (MRAs), global harmonization, etc., as described in the active Memorandum of Understanding between these Offices.
4.3 FDA Centers will implement this Policy in their regulatory activities. Each Center will establish procedures (e.g., Standard Operating Procedures and Policies (SOPP), Manual of Policy and Procedures (MAPP) for implementing relevant provisions of the Policy that may include development of appropriate documents (e.g. Appointment of Liaisons, Records Management, etc.)
5. Agency Coordination
To improve the internal coordination of FDA’s participation in standards development organizations (SDOs), FDA establishes the FDA Standards Committee (FDASC). The purpose of the FDASC is to ensure effective participation by FDA in the development of domestic and international standards and to promote FDA adherence to uniform policies in the development and use of standards and in conformity assessment activities.