🧬FDA Proposes Reclassification of Hematology Devices Affecting ISH Systems
Hematology and Pathology Devices; Reclassification of In Situ Hybridization Test Systems for Use With a Corresponding Approved Oncology Therapeutic Product
Summary
The Food and Drug Administration (FDA) is proposing to reclassify in situ hybridization (ISH) test systems indicated for use with a corresponding approved oncology therapeutic product (product codes NYQ, MVD, OWE, and PNK) from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation, along with the special controls that FDA believes are necessary to provide a reasonable assurance of safety and effectiveness for this device type.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The proposed reclassification from Class III to Class II for in situ hybridization (ISH) test systems will significantly lower regulatory burdens for manufacturers, allowing for more cost-effective 510(k) submissions rather than more expensive PMAs, thus enhancing market access and competitiveness in the oncology diagnostics sector.