FDA Announces Updates to Premarket Review Standards

Aug 05, 2011   

On August 2, 2011, the U.S. Food and Drug Administration (FDA) published a notice for comment in the Federal Register regarding updated, withdrawn and modified standards for reviewing premarket applications for medical devices. The notice, entitled Modifications to the List of Recognized Standards, Recognition List Number: 027, is intended to “assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.”

This notice describes 1) the withdrawal of standards and their replacement by others; 2) the correction of errors made by the 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 these standards. The FDA will incorporate these modifications into the list of FDA Recognized Consensus Standards.

Fuerst Ittleman is well-equipped to assist members of FDA-regulated industry navigate the laws and regulations applicable to medical device applications in the United States. For more information about the current regulatory framework surrounding medical devices, please contact us at contact@fidjlaw.com.