🦠FDA Classifies Antimicrobial Susceptibility Testing Device as Class II
Medical Devices; Immunology and Microbiology Devices; Classification of the Cellular Analysis System for Multiplexed Antimicrobial Susceptibility Testing
Summary
The Food and Drug Administration (FDA, the Agency, or we) is classifying the cellular analysis system for multiplexed antimicrobial susceptibility testing into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the cellular analysis system for multiplexed antimicrobial susceptibility testing's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's final classification of the cellular analysis system for multiplexed antimicrobial susceptibility testing as class II introduces regulatory requirements for compliance and market entry, thus affecting businesses in the medical device industry. It emphasizes the reduction of burdens for innovation, aligning with business strategies for improved access to the market.