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# Reclassify Some Oncology Panels: Petition
- URL: https://www.fdaweb.com/reclassify-some-oncology-panels-petition/
- Published: 2024-08-06T12:00:00.000Z
- Updated: 2026-09-14T14:37:26.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157510

Foundation Medicine is petitioning FDA to reclassify all next-generation sequencing oncology panel devices used for somatic or germline variant detection that include one or more companion diagnostic indications from Class III to Class II. Foundation’s just-released 6/28 [petition](https://downloads.regulations.gov/FDA-2024-P-3484-0001/attachment%5F1.pdf?ref=fdaweb.com) says the genomics company believes “there is sufficient information available to establish special controls that, if appropriately rigorous and combined with general controls, can provide a reasonable assurance of the safety and effectiveness of these devices.”

Absent a full PMA, Foundation says, appropriately rigorous special controls are the only way to ensure that patients and physicians have access to high-quality tests and the opportunity to benefit from the most effective therapy for their specific type of cancer.