FoundationOne CDx (F1CDx)
FDA premarket approval P170019/S023 · decided 2021-06-30
Approval details
- PMA number
- P170019
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- FoundationOne CDx (F1CDx)
- Generic name
- Next generation sequencing oncology panel, somatic or germline variant detection system
- Applicant
- Foundation Medicine, Inc.
- Date received
- 2020-12-01
- Decision date
- 2021-06-30
- Days to decision
- 211 days
- Decision code
- APPR
- Product code
- PQP
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Boston, MA
- Statement
- Approval for Expanding the indications for use to include a CDx indication for detecting ALK rearrangements in non-small cell lung cancer patients who may be candidates for brigatinib treatment.
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