🧬FDA Classifies Mutation Detection Test for Myeloproliferative Neoplasms
Medical Devices; Immunology and Microbiology Devices; Classification of the Mutation Detection Test for Myeloproliferative Neoplasms
Summary
The Food and Drug Administration (FDA, the Agency, or we) is classifying the mutation detection test for myeloproliferative neoplasms 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 mutation detection test for myeloproliferative neoplasms. 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
$$$ - High
The regulation classifies mutation detection tests for myeloproliferative neoplasms as Class II, which reduces regulatory burdens and enables faster market access for businesses. This classification allows devices to utilize a less burdensome 510(k) premarket notification process, potentially increasing innovation and competition.