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Voluntary consensus standards guidance updated by FDA

Posted 14 September 2020 | By Kari Oakes 

Voluntary consensus standards guidance updated by FDA

Voluntary consensus standards guidance updated by FDA
The US Food and Drug Administration has issued a final guidance addressing voluntary consensus standards, updating a September 2018 version.
The final guidance also supersedes one issued in 2007 by the Center for Devices and Radiological Health (CDRH) entitled “CDRH Standard Operating Procedures for the Identification and Evaluation of Candidate Consensus Standard for Recognition.”
The final document, issued jointly by CDRH and the Center for Biologics Evaluation and Research (CBER), lays out the procedures used by CDRH when the office receives requests for recognition of voluntary consensus standards for medical products.
Options for agency actions in this case include complete or partial recognition, or non-recognition. The agency may also withdraw standards from recognition.
In determining whether and how to recognize voluntary consensus standards, FDA seeks to ensure that the standards are “fair and relevant and useful for regulatory purposes,” according to the guidance.
Specific elements that FDA is looking to see in a consensus standard include openness, balance, the presence of due process and an appeals process, and an approach that involves consensus. The guidance outlines which standards are prioritized, clarifying that such organizations as the International Organization for Standardization (ISO) and ASTM International produce standards that meet these criteria, though professional and trade associations may also promulgate standards FDA will recognize.
The guidance lays out the procedure for requesting recognition, which, in addition to identifying information and the proposed list of product types to which the consensus statement would apply, should also include the basis for recognition. This, explained FDA, would include scientific, technical or regulatory details that form the basis for the consensus document. Any individual may also request recognition of a voluntary consensus standard.
The agency will make a determination regarding extent of recognition (EOR) and provide a rationale for its EOR determination. When a standard is partially recognized, FDA will indicate which parts are and are not recognized and provide a rationale for its decisions.
A variety of factors may play into a partial or complete non-recognition EOR, according to the guidance. These include specifications or methods that may be infeasible or scientifically unacceptable or in conflict with other standards or regulations. Also, the agency may decline to recognize a standard that “creates a barrier to domestic or international trade or that impedes innovation or technical progress.”
The final guidance, said FDA in announcing its release in the Federal Register, include revisions in response to comments received for the draft guidance. Revisions from the draft include “specifying that FDA will provide the rationale for complete and partial recognition and describing considerations for determining the timing of a transition period between versions of standards,” according to the Federal Register.
FDA-recognized consensus standards are maintained by the agency in a searchable database.


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Tags: devices, FDA, medical, US

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