🧬FDA Classifies Pharmacogenetic Assessment System as Class II Device
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System
Summary
The Food and Drug Administration (FDA, the Agency, or we) is classifying the pharmacogenetic assessment system 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 classification of the pharmacogenetic assessment system. We are taking this action because we have determined that classifying the device into class II 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 regulation classifies the pharmacogenetic assessment system into class II, which allows for less stringent requirements benefiting businesses manufacturing such devices. This reduces regulatory burdens and facilitates faster market access to innovation, indicating financial implications for device manufacturers and investors in the healthcare sector.