Since 1977, FDA has recognized consensus standards developed by international and national organizations to fulfill certain requirements of premarket review submissions.
Now the FDA has announced a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 055” (Recognition List Number: 055), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
In this publication, FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the Agency is recognizing for use in premarket submissions and other requirements for devices. FDA is incorporating these modifications to the list of FDA Recognized Consensus Standards in the Agency's searchable database. They are doling out the following changes, implemented from April 29th, 2021:
- (1) the withdrawal of standards and their replacement by others, if applicable;
- (2) the correction of errors made by FDA in listing previously recognized standards; and
- (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards.
The detailed list of changes may be consulted at this link.
- Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 055
- Section 204 of the Food and Drug Administration Modernization Act of 1997
- FDA Recognized Consensus Standards