🧬FDA Classifies Postnatal Chromosomal Detection System as Class II
Medical Devices; Immunology and Microbiology Devices; Classification of the Postnatal Chromosomal Copy Number Variation Detection System
Summary
The Food and Drug Administration (FDA, the Agency, or we) is classifying the postnatal chromosomal copy number variation detection 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 the postnatal chromosomal copy number variation detection system's classification. 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 postnatal chromosomal copy number variation detection system into class II, which reduces regulatory burdens. This impacts compliance costs and accelerates product market entry, benefiting businesses in the medical device sector.