On January 15, 2013 the Food and Drug Administration (FDA) published an updated list of standards the Agency recognizes for use in premarket reviews of medical devices. This publication, entitled “Modifications to the List of Recognized Standards, Recognition List Number: 030” will assist manufacturers who choose to declare conformity with consensus standards.
The FDA notice outlines additions, withdrawals, correction of errors, and revisions of standards recognized by the FDA. The majority of the changes are related to replacing obsolete revisions with the newest versions of the standards. In addition, Table 3 lists newly recognized standards and manufacturers should review the ones that are applicable to their operations. For example, medical device manufacturers whose products or quality systems incorporate software components should pay attention to four new entries added under the Software/Informatics section: Validation of Software for Regulated Processes (AAMI TIR362007), Guidance on the Application of ISO 14971 to Medical Device Software (IEC/TR 80002-1 Edition 1.0 2009-09), Application of Quality Management System Concepts to Medical Device Data Systems (ANSI/AAMI SW87 2012), and Guidance on the use of AGILE Practices in the Development of Medical Device Software (AAMI TIR45 2012).
The Agency’s current list of FDA recognized consensus standards may be accessed in a searchable database at the FDA website. In addition, you may want to revisit the FDA website and review Guidance on the Recognition and Use of Consensus Standards.