The Food and Drug Administration (FDA) developed this document to provide guidance to industry and FDA staff about the procedures the Center for Devices and Radiological Health (CDRH) follows when we receive a request for recognition of a voluntary consensus standard for medical products. The guidance outlines principles for recognizing a standard wholly, partly, or not at all, as well as reasons and rationales for withdrawing a standard.
For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.
Congress enacted the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-115) and the 21st Century Cures Act (Pub. L. 114-255). These acts amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by amending section 514(c), 21 U.S.C. 360d(c), regarding the recognition of standards.
The term “recognize” in section 514(c) of the FD&C Act refers to FDA’s identification of standards as appropriate for manufacturers of products to declare conformance to meet relevant requirements under the FD&C Act, including premarket submission requirements. This guidance refers to voluntary consensus standards recognized by FDA in the Federal Register in accordance with section 514(c) of the FD&C Act as “FDA-recognized consensus standards.”
CDRH’s Standards and Conformity Assessment Program (S-CAP) furthers the aim of international harmonization because the same standards (or international equivalents) are relied upon by sponsors to meet other countries’ regulatory requirements when appropriate. For example, adherence to such standards is an optional method of meeting the General Safety and Performance Requirements (“GSPR”) under the European Medical Device Regulation (“EU MDR”).
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