🧪FDA Classifies Cytomegalovirus Detection Device for Regulatory Ease
Medical Devices; Immunology and Microbiology Devices; Classification of the Cytomegalovirus Nucleic Acid Detection Device for Congenital Cytomegalovirus Infection
Summary
The Food and Drug Administration (FDA, Agency, or we) is classifying the cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection 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 cytomegalovirus nucleic acid detection device for congenital cytomegalovirus infection'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 classification of the cytomegalovirus detection device into class II (special controls) reduces regulatory burdens, which could ease market entry for manufacturers, leading to increased innovation in medical devices. This impacts businesses involved in developing or distributing these devices, suggesting a more accessible pathway to compliance and potential financial benefits.