---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-23-050935"
form_type: "8-K"
ticker: "RCEL"
cik: "0001762303"
company_name: "AVITA Medical, Inc."
filed_at: "2023-10-02T23:59:59+00:00"
generated_at: "2026-06-10T06:26:48.467320+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# AVITA Medical receives FDA additional info request for RECELL GO PMA; launch pushed to mid-2024

## Summary
- FDA placed RECELL GO PMA supplement on hold for ~4-6 months pending additional info.
- Review will resume 180-day cycle upon complete response, with 90 days remaining.
- Implied product launch is now between May 1 and July 1, 2024.
- PMA was submitted June 30, 2023 under Breakthrough Device program.
- Company received notice at halfway point of the 180-day review cycle.

## SEC filing metadata
- accession: 0000950170-23-050935
- form_type: 8-K
- ticker: RCEL
- cik: 0001762303
- company_name: AVITA Medical, Inc.
- filed_at: 2023-10-02T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1762303/000095017023050935/0000950170-23-050935-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1762303/000095017023050935/rcel-20231002.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-23-050935
- JSON: https://secwatch.observer/filing/0000950170-23-050935.json
- Plain text: https://secwatch.observer/filing/0000950170-23-050935.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.