Regulatory Focus™ > News Articles > 2020 > 1 > FDA Recognizes New Version of ISO 14971, More Than 100 Other Consensus Standards

FDA Recognizes New Version of ISO 14971, More Than 100 Other Consensus Standards

Posted 16 January 2020 | By Michael Mezher 

FDA Recognizes New Version of ISO 14971, More Than 100 Other Consensus Standards

The US Food and Drug Administration (FDA) in late December recognized the newly revised International Organization for Standardization (ISO) risk management standard for medical devices, ISO 14971:2019, along with more than 100 other consensus standards.
 
The move came shortly after ISO released the new version of the standard, now in its third revision, and extended FDA recognition to dozens of other consensus standards developed by ISO, the Association for the Advancement of Medical Instrumentation (AAMI), the American National Standards Institute (ANSI), ASTM International and the United States Pharmacopoeia (USP), among others.
 
The standards recognized are wide ranging, covering topics such as anesthesiology, biocompatibility, materials, physical medicine, radiology, software and sterility.
 
FDA updates its list of recognized consensus standards quarterly, and according to the agency’s September 2018 guidance, standards may be referenced as soon as they are published to the agency’s database. FDA also publishes Federal Register notices listing newly recognized standards.
 
As for the transition to ISO 14971:2019, FDA says it will still accept declarations of conformity to the previous version, ISO 14971:2007, in support of premarket submissions until 25 December 2022. “After this transition period, declarations of conformity to [ISO 14971:2007] will not be accepted,” the agency says.
 
Alongside ISO 14971:2019, FDA recognized AAMI TIR97 Principles for medical device security—Postmarket risk management for device manufacturers, which AAMI says “provides detailed guidance for addressing the unique challenges of maintaining the security of a medical device during its entire life cycle.”
 
The new TIR97 standard is meant to be read alongside the earlier TIR57:2016 Principles for medical device security—Risk management.
 
FDA, AAMI

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