FoundationOne CDx
FDA premarket approval P170019/S025 · decided 2021-11-10
Approval details
- PMA number
- P170019
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne CDx
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2020-12-28
- Decision date
- 2021-11-10
- Days to decision
- 317 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for the FoundationOne CDx. The device is intended use is expanded to grant companion diagnostic group labeling claims for melanoma patients harboring BRAF V600E alterations for BRAF inhibitor monotherapy group claim and for BRAF V600E or V600K alterations for BRAF/MEK inhibitor combination group claim.
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