USA: FDA Modifies List of Standards for Premarket Device Reviews

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

The FDA has published in the Federal Register 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 and 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.