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Regulatory News | 09 July 2014 | By Alexander Gaffney, RAC
US medical device regulators have announced more than 30 new additions to their list of recognized device consensus standards.
In a Federal Register announcement on 9 July 2014, the US Food and Drug Administration (FDA) announced its 36th update to its "List of Recognized Standards"—its fourth update to the list in 2014—containing dozens of modifications and 33 newly recognized standards.
Those standards come to be recognized by FDA through a process known as "incorporation by reference." Because the standards are often highly technical, time-consuming to produce and expensive to create, FDA defers to outside technical experts to create the standards, and then adopts those standards—sometimes with changes, but most often without—for use by regulated industry.
Members of industry are then responsible for complying with those standards, and usually must pay to access them.
So far this year, FDA has released three updates to the list of recognized standards:
Those updates have ranged from the minute, such as update 33's five new standards and 35's three new standards, but can also be massive, such as update 34's hundreds of changes and two dozen additions.
FDA's newest Recognition List, number 36, appears to be its largest yet this year, with 33 new standards and 153 changes to existing standards.
All newly-recognized standards may be found below. All other standards can be found in FDA's Federal Register notice.
Tags: List of Recognized Standards, Medical Device Standards, Incorporation by Reference