FDA Modifies List of Standards for Premarket Device Reviews

Regulatory NewsRegulatory News | 23 October 2019 |  By 

The modified list of standards published on Wednesday is meant to assist medical device manufacturers that elect to declare conformity with consensus standards to meet certain US Food and Drug Administration (FDA) requirements.

Back in 1997, the Food and Drug Administration Modernization Act allowed FDA to recognize consensus standards developed by national and international organizations to satisfy certain portions of device premarket review submissions or other requirements.

Since then, FDA has published final guidance in September 2018 on the appropriate use of voluntary consensus standards in premarket submissions and draft guidance on the recognition and withdrawal of voluntary consensus standards.

Published in the Federal Register on Wednesday are two tables that include new entries to the list of recognized standards, and another list containing the withdrawal of standards and their replacement by others, if applicable, the correction of errors made by FDA in listing previously recognized standards and changes to the supplementary information.

The table on modified standards includes those related to anesthesiology, biocompatibility, cardiovascular, dental/ear, nose and throat, quality systems/risk management, general hospital/plastic surgery, in vitro diagnostics, materials, ophthalmic, orthopedic, radiology, sterility and tissue engineering.

In addition to most of these categories, the second list of new standards also includes ones related to nanotechnology, physical medicine, software/informatics.

The standards are primarily from ISO, ASTM, CLSI, UL, CLSI, ANSI and IEEE, and range from a standard for standby batteries to one on medical device safety assurance to point-of-care device communication.

Federal Register

Recognized Consensus Standards Searchable Database


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