US FDA releases Modifications to the List of Recognized Standards


The US FDA announced a publication containing modifications made to the list of standards FDA recognizes for use in premarket review (FDA Recognized Consensus Standards). This publication will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The US FDA has released information pertaining to:

1. Modifications to the list of recognized standards (Table 1) which includes

  • The withdrawal of standards and their replacement by others, if applicable;

  • the correction of errors made by FDA in listing previously recognized standards; and

  • the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.

2. New entries to the list not previously recognized by the FDA (Table 2).

For more information on the List, check out the following link:

- Recognition List Number: 050

Contact us at info@arqon.com.


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