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Routine Notice Added Final

CDRH Acknowledgment Letter to Shane Parker - FDA-2025-V-5013

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Summary

FDA CDRH issued an acknowledgment letter to Shane Parker in response to submission FDA-2025-V-5013. The acknowledgment letter confirms receipt of the submission but the actual document content is not publicly available due to personally identifiable information protections.

What changed

This document is an administrative acknowledgment letter from FDA CDRH confirming receipt of a submission (FDA-2025-V-5013) filed by Shane Parker. The actual submission content is not publicly viewable due to PII protections, with only a redacted version available.

Affected parties who filed submissions with FDA CDRH should monitor Regulations.gov for any responsive communications or requests for additional information related to their filings. This acknowledgment confirms the submission entered the administrative review process but does not indicate any substantive determination.

What to do next

  1. Monitor Regulations.gov for updates to FDA-2025-V-5013

Archived snapshot

Apr 10, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Content

There are no documents available to view or download

Attachments 2

Acknowledgment Letter from FDA DMB to Shane Parker

Restricted: Personally Identifiable Information

More Information
- Author(s) CDRH

Acknowledgment Letter from FDA DMB to Shane Parker_Redacted

More Information
- Author(s) CDRH
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Last updated

Classification

Agency
FDA
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
FDA-2025-V-5013
Docket
FDA-2025-V-5013

Who this affects

Applies to
Medical device makers
Industry sector
3345 Medical Device Manufacturing
Activity scope
Device submission filing Regulatory correspondence
Geographic scope
United States US

Taxonomy

Primary area
Medical Devices
Operational domain
Regulatory Affairs
Compliance frameworks
GxP
Topics
Healthcare Administrative Law

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